Coronary Disease Morbidity And Mortality In A Population
Veronique L Roger, Professor Of Medicine
Mayo Clinic Coll Of Medicine, Rochester
Grant 2R01HL059205-10A1 from National Heart, Lung, And Blood Institute, IRG: ZRG1
Abstract: Coronary heart disease (CHD) is the leading cause of death and the decline in age-adjusted mortality reflects a shift in the occurrence of death towards older persons. Further, the staggering morbidity of cardiovascular disease will likely increase with the obesity and diabetes epidemics. The American Heart Association and Healthy People 2010 defined goals to improve cardiovascular health, which require population surveillance to assess progress. Our study responds to this need by measuring CHD events, evaluating their prognosis and management in a geographically-defined population. We demonstrated that the incidence of myocardial infarction (MI) remained stable over time while trends diverged by age and sex with an increase in women and the elderly. CHD mortality trends also showed a shift in the burden of CHD towards women and the elderly. Trends in MI incidence paralleled CHD incidence, supporting the conventional approach of relying on MI to assess CHD trends. The definition of MI was then changed to recommend troponin as the preferred biomarker. As troponin is more sensitive than previous biomarkers (creatine kinase and its MB fraction), it was hypothesized that the new definition would change the number and case mix of MI. To test this hypothesis, we amplified our passive surveillance with a novel prospective approach, measured both new and previous biomarkers in all cases in the same population and determined that the new criteria markedly increased the number of MIs but the increment varied according to the clinical acceptance of the new criteria. Importantly, the new definition obscured the boundaries between unstable angina (UA) and MI such that CHD surveillance must now pertain to acute coronary syndromes (ACS) including UA. The biomarker change also altered case mix and outcome. Finally, while troponin predicts risk in ACS, other markers also offer prognostic information. We showed that C-Reactive Protein (CRP) was associated with heart failure (HF) and death while lipoprotein- associated phospholipase A2 (Lp-PLA2), was associated with death but not HF or ischemia post MI. This underscores the challenges of a "multimarker strategy" for risk prediction as risk differs by time or type of event. Further, the added value of novel markers over known indicators should be evaluated. We propose in Aim 1, to examine the incidence and survival of ACS (MI and UA) to test the hypotheses that incidence of ACS remained stable, but the incidence of MI increased while that of UA decreased and that the survival of ACS improved while MIs had worse survival than UA cases. In Aim 2, to prospectively characterize case mix and test the hypothesis that cases meeting only troponin criteria have better outcomes than those meeting CKMB- criteria. In Aim 3 to test the hypothesis that novel biomarkers predict risk after ACS but that the associations vary according to the type of biomarker and event. We will assess the added value of biomarkers over that of known predictors. Our research is uniquely possible in this setting as it builds on the proven method and findings of previous grant cycles to integrate passive surveillance and prospective studies in the community. This research will provide important information on the burden of heart disease in the community as measured by acute coronary syndromes, including unstable angina and myocardial infarction. It will determine the importance of novel biomarkers to predict the risk of adverse events in clinical practice
Project start date: 1998-01-15
Project end date: 2013-05-31
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Coronary Disease Morbidity And Mortality In A Population
Veronique L Roger, Professor Of Medicine
Mayo Clinic Coll Of Medicine, Rochester 200 1st St Sw Rochester, Mn 55905
Grant 2R01HL059205-05A1 from National Heart, Lung, And Blood Institute, IRG: EDC
Abstract: In Olmsted County, data acquired during the initial cycle of RO1 HL59205 document diverging CHD secular trends as a function of sex and age with less favorable changes in CHD mortality, MI incidence and post-MI mortality and morbidity among the elderly. These data, consistent across all indicators measured, underscore that, notwithstanding the decline in age- adjusted CHD deaths, the burden of CHD remains considerable and the morbidity of MI is substantial despite therapeutic progress. These adverse trends have profound implications in an aging population and their continued monitoring is of paramount importance to understand the burden of CHD. To this end, the clinical criteria to diagnose MI, an essential indicator of CHD, recently changed to rely on troponin, a new biomarker with enhanced diagnostic yield. This will increase the number of cases and shift the spectrum of disease, which has profound clinical as well as public health consequences. Surveillance studies play a central role in the measurement of CHD trends and the interpretation of the epidemiological and clinical implications of such changes, which to date have not been studied. For non-concurrent programs, however this important task poses considerable challenges recognized by the NHLBI Working Group on Community Surveillance, which recommended studies collecting simultaneously troponin and CK/CKMB. Building on methods developed during the initial cycle of our grant, the present competitive renewal proposes a novel active surveillance approach required for the dual ascertainment of each case with both troponin and CK/CKMB. Novel approaches to the procurement of carefully timed blood samples will allow us to directly measure the increase in the number of cases of MI due to troponin, directly ascertain the subsequent change in case mix and interpret outcomes, while also assessing concomitant trends in therapies. Further, we propose to capitalize on this active system to examine the prognostic value of quantitative peak troponin (measured at 24-36 hours) and high sensitivity (hs) CRP (measured early after symptom onset) in our MI cohort. These markers were proposed to stratify risk among cases of acute coronary syndromes with elevated troponin but negative CK/CKMB, classified as MIs by the new criteria, such that prognostic studies should examine jointly the value of both markers. To these ends, we propose four specific aims. 1) To examine the impact of the use of troponin on the incidence of hospitalized MI and test the hypothesis that troponin is temporally associated with an increase in incidence, which has not changed when measured with CK/CKMB 2) To measure the trends in the clinical presentation and severity of MI and test the hypotheses that MIs identified only by troponin are less severe than those identified by CK/CKMB. 3) To study the outcomes of MI and test the hypotheses that, they differ in MIs identified only by troponin as compared to MIs identified by CK/CKMB. 4) To examine the prognostic value of peak troponin and hsCRP to test the hypotheses that they provide prognostic information, incremental to conventional risk indicators. The significance of this study resides in the fact that, through our approach, we will quantify any increase in MI incidence due to troponin, measure directly the resulting change in case mix and analyze subsequent outcomes while simultaneously ensuring continuity for MI surveillance. This is crucial to understand the implications of MI diagnoses as newly defined and changing CHD trends, both aspects critically needed for clinical care as well as for epidemiological studies.
Keywords: biomarker, cardiovascular disorder diagnosis, cardiovascular disorder epidemiology, coronary disorder, creatine kinase, diagnosis design /evaluation, human morbidity, human mortality, myocardial infarction, troponin, cardiovascular disorder risk, diagnosis quality /standard, prognosis, serology /serodiagnosis, electrocardiography, human subject, patient oriented research, postmortem
Project start date: 1998-01-15
Project end date: 2007-06-30
2R01HL059205-05A1 (2002): $366612
Grants awarded to Veronique L Roger
Heart Failure In The Community
Veronique L Roger, Professor Of Medicine
Mayo Clinic Coll Of Medicine, Rochester
Grant 5R01HL072435-06 from National Heart, Lung, And Blood Institute, IRG: CASE
Abstract: This study investigates the heart failure (HF) epidemic using community surveillance in a geographically defined population. In the current grant cycle (2003-06), we demonstrated that the incidence of HF, including in and out-patient cases, remained stable overtime while survival improved, thereby leading to an increasing prevalence of HF. This indicates that the HF epidemic is due to an increase in hospitalizations over time among a growing number of survivors. In this revised renewal application, we propose to investigate hospitalizations in HF and address the following questions Is the increase in hospitalizations solely due to the increasing prevalence of HF in a growing population or is it related to an increasing number of recurrent hospitalizations per survivor? What are the risk factors for hospitalizations in HF, including determinants of recurrent events? This investigation should account for key methodological points, lacking from current literature Temporal trends should be analyzed in an incidence cohort to avoid incidence-prevalence bias. Outpatient cases should be included as 42% of HF is diagnosed as outpatient. All-cause and HF-specific hospitalizations should be rigorously ascertained and examined in the same population. Indeed, HF-related hospitalizations relate to the effectiveness of the treatment of HF while all-cause hospitalization may reflect comorbidity among elderly patients with HF. Finally, analytical strategies should include the evaluation of multiple events. Two essential exposures should be prospectively captured the type of HF, defined by ejection fraction (EF) and diastolic function given the heterogeneity of the HF syndrome (56% of prospectively ascertained patients in the community had normal EF and 64% of these have moderate or severe diastolic dysfunction) and psycho-social constructs, in particular health status. We propose to apply the rigorous surveillance methods implemented during the 1st grant cycle to address the following aims Specific aim 1- temporal trends in all-cause and HF-specific hospitalizations after incident HF between 1979 and 2008. Specific aim 2- Association between type of HF (EF and diastolic function) and hospitalizations in a cohort of persons with validated HF, prospectively enrolled with an innovative approach using the electronic medical record that enables rapid ascertainment of cases of active HF. Specific aim 3- Association between health status and hospitalizations in HF prospectively measured using a generic instrument, the Short Form 12 and a disease specific instrument, the Kansas City Cardiomyopathy Questionnaire. The completion of these studies is uniquely possible in this setting because we will build on the proven methodology and findings of the initial funding period and capitalize on the infrastructure of the Rochester Epidemiology Project that captures in- and outpatient events, comorbid conditions and outcomes. Our team of investigators, strengthened by the addition of an expert in psychosocial constructs in HF, Dr. Moser, will employ novel and complementary design and analytical approaches that integrate passive surveillance and prospective identification of persons with HF at diagnosis in the same community. In doing so, we will gain important insights into the burden of hospitalizations among persons living with HF, which are a major driver of human, societal and heath care costs in HF. This will help define preventive strategies
Keywords: cardiovascular disorder epidemiology, community, disease /disorder etiology, heart failure cardiovascular disorder risk, comorbidity, congestive heart failure, coronary disorder, diabetes mellitus, heart disorder diagnosis, hospital utilization, human population study, hypertension, obesity clinical research, echocardiography, human subject, medical record, questionnaire
Project start date: 2007-07-01
Project end date: 2012-06-30
2R01HL072435-05A1 (2007): $708914
Coronary Disease Morbidity And Mortality In A Population
Veronique L Roger, Professor Of Medicine
Mayo Clinic Coll Of Medicine, Rochester 200 1st St Sw Rochester, Mn 55905
Grant 5R01HL059205-09 from National Heart, Lung, And Blood Institute, IRG: EDC
Abstract: In Olmsted County, data acquired during the initial cycle of RO1 HL59205 document diverging CHD secular trends as a function of sex and age with less favorable changes in CHD mortality, MI incidence and post-MI mortality and morbidity among the elderly. These data, consistent across all indicators measured, underscore that, notwithstanding the decline in age- adjusted CHD deaths, the burden of CHD remains considerable and the morbidity of MI is substantial despite therapeutic progress. These adverse trends have profound implications in an aging population and their continued monitoring is of paramount importance to understand the burden of CHD. To this end, the clinical criteria to diagnose MI, an essential indicator of CHD, recently changed to rely on troponin, a new biomarker with enhanced diagnostic yield. This will increase the number of cases and shift the spectrum of disease, which has profound clinical as well as public health consequences. Surveillance studies play a central role in the measurement of CHD trends and the interpretation of the epidemiological and clinical implications of such changes, which to date have not been studied. For non-concurrent programs, however this important task poses considerable challenges recognized by the NHLBI Working Group on Community Surveillance, which recommended studies collecting simultaneously troponin and CK/CKMB. Building on methods developed during the initial cycle of our grant, the present competitive renewal proposes a novel active surveillance approach required for the dual ascertainment of each case with both troponin and CK/CKMB. Novel approaches to the procurement of carefully timed blood samples will allow us to directly measure the increase in the number of cases of MI due to troponin, directly ascertain the subsequent change in case mix and interpret outcomes, while also assessing concomitant trends in therapies. Further, we propose to capitalize on this active system to examine the prognostic value of quantitative peak troponin (measured at 24-36 hours) and high sensitivity (hs) CRP (measured early after symptom onset) in our MI cohort. These markers were proposed to stratify risk among cases of acute coronary syndromes with elevated troponin but negative CK/CKMB, classified as MIs by the new criteria, such that prognostic studies should examine jointly the value of both markers. To these ends, we propose four specific aims. 1) To examine the impact of the use of troponin on the incidence of hospitalized MI and test the hypothesis that troponin is temporally associated with an increase in incidence, which has not changed when measured with CK/CKMB 2) To measure the trends in the clinical presentation and severity of MI and test the hypotheses that MIs identified only by troponin are less severe than those identified by CK/CKMB. 3) To study the outcomes of MI and test the hypotheses that, they differ in MIs identified only by troponin as compared to MIs identified by CK/CKMB. 4) To examine the prognostic value of peak troponin and hsCRP to test the hypotheses that they provide prognostic information, incremental to conventional risk indicators. The significance of this study resides in the fact that, through our approach, we will quantify any increase in MI incidence due to troponin, measure directly the resulting change in case mix and analyze subsequent outcomes while simultaneously ensuring continuity for MI surveillance. This is crucial to understand the implications of MI diagnoses as newly defined and changing CHD trends, both aspects critically needed for clinical care as well as for epidemiological studies.
Keywords: biomarker, cardiovascular disorder diagnosis, cardiovascular disorder epidemiology, coronary disorder, creatine kinase, diagnosis design /evaluation, human morbidity, human mortality, myocardial infarction, troponin, cardiovascular disorder risk, diagnosis quality /standard, prognosis, serology /serodiagnosis, electrocardiography, human subject, patient oriented research, postmortem
Project start date: 1998-01-15
Project end date: 2008-06-30
5R01HL059205-09 (2006): $400161
5R01HL059205-08 (2005): $399846
5R01HL059205-07 (2004): $388939
5R01HL059205-06 (2003): $377613
Heart Failure In The Community
Veronique L Roger, Professor Of Medicine
Mayo Clinic Coll Of Medicine, Rochester 200 1st St Sw Rochester, Mn 55905
Grant 1R01HL072435-01 from National Heart, Lung, And Blood Institute, IRG: EDC
Abstract: Heart failure (HF) is designated as an emerging epidemic. Yet, it is not fully characterized. Most data, derived from hospital discharges, cannot measure incidence, have uncertain validity and cannot capture the full burden of HF because of the shift towards outpatient care. Regarding its etiology, the respective role of hypertension and coronary heart disease (CHD) is controversial. Moreover, the prevalence of obesity and diabetes mellitus is increasing, both conditions linked to HF via several mechanisms such that their contribution to HF could conceivably be increasing but remains to be examined. Finally, while the existence of diastolic HF is recognized, its diagnosis is exclusionary based on symptoms of HF in the absence of LV systolic dysfunction. This approach is unsatisfactory, thus the contribution of DHF to HF remains contentious. These striking gaps in knowledge underscore the necessity of a rigorous investigation of the HF epidemic. Through surveillance of the Olmsted County community, we demonstrated the postponement of CHD towards older ages and the decline over time in the severity of hospitalized MI and the incidence of HF after MI. This implies that, if CHD is the main cause of HF, HF should be postponed towards older ages and its incidence rate relatively stable. During the same period, preliminary findings on HF surveillance suggest that the incidence of first clinical diagnosis of HF may not be increasing as much as implied by hospital discharges and that adverse trends may be occurring preferentially among younger ages. These data from the same community are challenging to reconcile with the concept of an ongoing major contribution of CHD to an epidemic of HF, thereby underscoring the need to rigorously study the epidemiology of HF, which is the focus of this application. We propose 3 specific aims and a community surveillance approach, integrated with our ongoing work on CHD surveillance to investigate the HF epidemic in Olmsted County by characterizing its magnitude and determinants and studying prospectively the contribution of DHF. Aim 1 will estimate the secular trends in the incidence and in the outcome of validated HF to test the hypotheses that there has been an increase in the incidence of HF, which differs by age and sex and that the survival of HF improved while hospitalization for HF has increased. Aim 2 will use a case-control approach to characterize the etiology of HF and its changes over time to test the hypotheses that CHD and hypertension confer an excess risk of HF, the magnitude of which is declining over time, that obesity and diabetes mellitus confer an excess risk of HF the magnitude of which is increasing and that the population attributable risk of CHD and hypertension for HF is declining, while that of obesity and diabetes mellitus is increasing over time. Aim 3 will prospectively characterize the contribution of DHF to HF using brain natriuretic peptide (BNP) among persons with HF and define the prognostic value of BNP in all cases of HF. Thus, the completion of these aims will provide important insights into the epidemiology of HF.
Keywords: cardiovascular disorder epidemiology, community, disease /disorder etiology, heart failure, cardiovascular disorder risk, comorbidity, congestive heart failure, coronary disorder, diabetes mellitus, heart disorder diagnosis, hospital utilization, human population study, hypertension, obesity, blood chemistry, clinical research, echocardiography, human subject, medical record, outcomes research
Project start date: 2003-01-15
Project end date: 2006-12-31
1R01HL072435-01 (2003): $584277
Myocardial Infarction In The Population
Veronique L Roger, Professor Of Medicine
Mayo Clinic Coll Of Medicine, Rochester 200 1st St Sw Rochester, Mn 55905
Grant 5K24HL068765-05 from National Heart, Lung, And Blood Institute, IRG: ZHL1
Abstract: Coronary heart disease (CHD) trends measured via our companion grant R01 HL 59205 document adverse secular trends among the elderly with regards to CHD mortality, MI incidence and post-MI survival. These trends, consistent across all indicators measured, document a shift in the burden of CHD towards older segments of the population and underscore the importance of including all ages to capture age-related differences in outcome and of the access to outpatient data to comprehensively characterize the burden of prevalent CHD. To provide insight into the impact and determinants of CHD trends, which have substantial implications in an aging population, a comprehensive analysis of post-MI outcomes including recurrent ischemic events and heart failure is needed. Indeed, although declining over time, heart failure remains frequent after incident MI and its determinants are not well known. In particular, there is virtually no population-based data on the occurrence of left ventricular (LV) dysfunction and LV remodeling (defined by changes over time in LV geometry), a known precursor of heart failure and on the independent role of age on LV remodeling. The acquisition of such data will be limited by the following factors 1) Older age groups, comprising the highest risk and fastest growing segment of the population, are not included in several surveillance programs. 2) Recent changes in the bio-marker used to diagnose MI clinically will introduce discontinuity in the trends measured through passive surveillance and modify the spectrum of disease labeled as MI. 3) Hospital-based surveillance does not capture outpatient outcomes, an important component of disease prevalence with current shifts away from in-patient care. The exceptional patient-oriented research environment at the Mayo Clinic optimized by the Mayo Clinic Echocardiographic Laboratory and the Rochester Epidemiology Project is a unique resource to address these questions thereby providing a rich experience in patient oriented research to junior investigators. Thus, building on methods implemented through our companion grant, in conjunction with novel and prospective approaches, the objective of this K24 grant is to develop a program to mentor junior investigators in patient-oriented research. The scientific aims of this application are to examine 1) Using prospectively acquired data, the impact of the implementation of Troponin-based diagnostic algorithms on the incidence of hospitalized MI and on CHD mortality. 2) The trends in the severity, natural history and utilization of cardiac procedures after incident MI and the impact of age on such trends. 3) Using prospectively acquired data, the prevalence and change in echocardiographically determined parameters of LV geometry and function in order to determine the prevalence of LV systolic dysfunction after MI, and the incidence of post-MI LV remodeling. To optimize the training potential of these series of studies and the learning experience of mentees a strong mentoring plan is outlined in details in this revised application.
Keywords: age difference, cardiovascular disorder epidemiology, heart disorder diagnosis, heart failure, heart function, heart ventricle, human old age (65+), myocardial infarction, biomarker, echocardiography, human mortality, medical complication, troponin, clinical research, human data, patient oriented research
Project start date: 2002-08-15
Project end date: 2008-04-30
5K24HL068765-05 (2006): $96342
5K24HL068765-04 (2005): $96342
5K24HL068765-03 (2004): $95827
5K24HL068765-02 (2003): $95827
1K24HL068765-01A1 (2002): $95827
Coronary Disease Morbidity And Mortality In A Population
Veronique L Roger, Professor Of Medicine
Mayo Clinic Coll Of Medicine, Rochester
Grant 2R01HL059205-10A1 from National Heart, Lung, And Blood Institute, IRG: ZRG1
Abstract: Coronary heart disease (CHD) is the leading cause of death and the decline in age-adjusted mortality reflects a shift in the occurrence of death towards older persons. Further, the staggering morbidity of cardiovascular disease will likely increase with the obesity and diabetes epidemics. The American Heart Association and Healthy People 2010 defined goals to improve cardiovascular health, which require population surveillance to assess progress. Our study responds to this need by measuring CHD events, evaluating their prognosis and management in a geographically-defined population. We demonstrated that the incidence of myocardial infarction (MI) remained stable over time while trends diverged by age and sex with an increase in women and the elderly. CHD mortality trends also showed a shift in the burden of CHD towards women and the elderly. Trends in MI incidence paralleled CHD incidence, supporting the conventional approach of relying on MI to assess CHD trends. The definition of MI was then changed to recommend troponin as the preferred biomarker. As troponin is more sensitive than previous biomarkers (creatine kinase and its MB fraction), it was hypothesized that the new definition would change the number and case mix of MI. To test this hypothesis, we amplified our passive surveillance with a novel prospective approach, measured both new and previous biomarkers in all cases in the same population and determined that the new criteria markedly increased the number of MIs but the increment varied according to the clinical acceptance of the new criteria. Importantly, the new definition obscured the boundaries between unstable angina (UA) and MI such that CHD surveillance must now pertain to acute coronary syndromes (ACS) including UA. The biomarker change also altered case mix and outcome. Finally, while troponin predicts risk in ACS, other markers also offer prognostic information. We showed that C-Reactive Protein (CRP) was associated with heart failure (HF) and death while lipoprotein- associated phospholipase A2 (Lp-PLA2), was associated with death but not HF or ischemia post MI. This underscores the challenges of a "multimarker strategy" for risk prediction as risk differs by time or type of event. Further, the added value of novel markers over known indicators should be evaluated. We propose in Aim 1, to examine the incidence and survival of ACS (MI and UA) to test the hypotheses that incidence of ACS remained stable, but the incidence of MI increased while that of UA decreased and that the survival of ACS improved while MIs had worse survival than UA cases. In Aim 2, to prospectively characterize case mix and test the hypothesis that cases meeting only troponin criteria have better outcomes than those meeting CKMB- criteria. In Aim 3 to test the hypothesis that novel biomarkers predict risk after ACS but that the associations vary according to the type of biomarker and event. We will assess the added value of biomarkers over that of known predictors. Our research is uniquely possible in this setting as it builds on the proven method and findings of previous grant cycles to integrate passive surveillance and prospective studies in the community. This research will provide important information on the burden of heart disease in the community as measured by acute coronary syndromes, including unstable angina and myocardial infarction. It will determine the importance of novel biomarkers to predict the risk of adverse events in clinical practice
Project start date: 1998-01-15
Project end date: 2013-05-31
5R01HL059205-04 (2001): $320444
5R01HL059205-03 (2000): $287167
5R01HL059205-02 (1999): $374467
1R01HL059205-01 (1998): $340501
Heart Failure In The Community
Veronique L Roger, Professor Of Medicine
Mayo Clinic Coll Of Medicine, Rochester 200 1st St Sw Rochester, Mn 55905
Grant 5R01HL072435-04 from National Heart, Lung, And Blood Institute, IRG: EDC
Keywords: cardiovascular disorder epidemiology, community, disease /disorder etiology, heart failure, cardiovascular disorder risk, comorbidity, congestive heart failure, coronary disorder, diabetes mellitus, heart disorder diagnosis, hospital utilization, human population study, hypertension, obesity, blood chemistry, clinical research, echocardiography, human subject, medical record, outcomes research
Project start date: 2003-01-15
Project end date: 2007-06-30
5R01HL072435-04 (2006): $639592
5R01HL072435-03 (2005): $674827
5R01HL072435-02 (2004): $561543
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