Occluded Artery Trial: Long Term Follow-Up
Judith S Hochman, Professor Of Medicine
Medicinenew York University School Of Medicine
Grant 5U01HL062509-08 from National Heart, Lung, And Blood Institute IRG: ZHL1
Project start date: 1999-09-30
Project end date: 2011-05-31
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OCCLUDED ARTERY TRIAL--CLINICAL COORDINATING CENTER
Judith S Hochman, Professor Of Medicine
St. Luke´s-roosevelt Inst For Hlth Scis
new York, Ny 10019
Grant 5U01HL062509-03 from National Heart, Lung, And Blood Institute IRG: ZHL1
Abstract: Background. The benefits of establishing early coronary reperfusion in acute myocardial infarction (MI) have now been unequivocally established. However, current pharmacological strategies fail to achieve effective reperfusion in 30% or more of patients, and many patients with occluded infarct arteries do not meet current criteria for use of these agents. Early angioplasty, an effective reperfusion method, is available to a small proportion of potentially eligible US acute MI patients. Hence, a substantial number of acute MI patients pass the time when reperfusion therapy has any documented benefit (12-24 hours) with a persistently closed infarct vessel. Several lines of experimental and clinical evidence suggest that late reperfusion of these patients could provide clinically significant reductions in mortality and morbidity. Hypothesis The central hypothesis of the Open Artery Trial is that opening an occluded infarct artery 3-21 days after an acute MI in high-risk asymptomatic patients (ejection fraction less than 50% or proximal occlusion of a large coronary artery) will reduce the composite endpoint of mortality, recurrent MI, and hospitalization for NYHA class IV congestive hear failure (CHF) over an average three year follow-up. Specific aims. The study will be a prospective clinical trial with 3,200 patients randomly allocated in equal proportions to two tretments arms over two years. One treatment will consist of conventional medical management (including aspirin, beta blockers, ACE inhibitors, and risk factor modification). The experimental treatment will consist of conventional medical therapy plus percutaneous coronary intervention and coronary stenting. Clinical outcomes will be compared using an intention-to-treat analysis. We have one primary specific aim 1) To compare the composite outcome of all-cause mortality, non-fetal MI and hospitalization of NYHA class IV CHF based on an average three year follow-up among patients assigned to the two treatments. We have three secondary specific aims 1) To compare the individual components of the study composite primary endpoint in the two treatment arms. 2) To compare the medical costs of the two treatments and assess the cost effectiveness of percutaneous revascularization in the study population. 3) To compare health-related quality of life in the two treatment groups. Operations. The Luke´s-Roosevelt Hospital in New York City. The Data Coordinating Center (DCC) is at the Maryland Medical Research Institute. The Economics and Quality of Life Coordinating Center is at Duke University. The Angiographic Core Laboratory is at the University of British Columbia
Keywords: artery occlusion, human therapy evaluation, intraluminal angioplasty, myocardial infarction ACE inhibitor, aspirin, beta adrenergic agent, blood vessel prosthesis, cardiovascular disorder epidemiology, clinical trial phase II /III /IV, combination therapy, cooperative study, health care cost /financing, heart disorder chemotherapy, quality of life, reperfusion clinical research, human subject
Project start date: 1999-09-30
Project end date: 2004-08-31
5U01HL062509-03 (2001): $1554161
5U01HL062509-02 (2000): $4022887
Grants awarded to Judith S Hochman
EARLY REVASCULARIZATION FOR CARDIOGENIC SHOCK
Judith S Hochman, Professor Of Medicine
St. Luke s-roosevelt Inst For Hlth Scis New York, Ny 10019
Grant 5R01HL050020-02 from National Heart, Lung, And Blood Institute IRG: CLTR
Abstract: This 5-year multi-center randomized trial will assess the effectiveness of Early Revascularization (ERV) using approved mechanical and surgical procedures (primarily PTCA and CABG) in reducing the current high in- hospital mortality rate from cardiogenic shock (CS) complicating acute myocardial infarction (MI). Approximately 7.5% of all MI s which are diagnosed in an ER or in-hospital lead to CS and in-hospital death rate of 70%-80% (usually within 1-2 days of diagnosis of CS). This high death rate has not changed in the last two decades. Non-random clinical series and animal studies suggest that rapid revascularization following CS complicating acute MI may substantially improve survival. However the apparent benefit reported in the non-random clinic studies could have resulted (partly) from a selection bias towards patients with a better prognosis. The primary goal of this trial is to assess the effectiveness of ERV (within 16 hours of CS diagnosis and within 40 hours post MI) in reducing in-hospital mortality by a minimum of 20% absolute reduction or more with 90% power comparing 130 patients randomized to ERV with 130 patients randomized to conventional therapy (CT) consisting of thrombolytics and a possible late attempt at revascularization (greater than or equal to 88 hours post MI). Secondary aims include 1. comparing survival at 6 months post-MI; and 2. assessing the quality of life among survivors using three measures (a subjective Quality of Life assessment designed for this type of post-MI population, a physical functioning questionnaire from which NYHA functional classes I-IV can be constructed). All patients with a clinically suspected diagnosis of CS complicating MI will form a Registry, with limited information collected on in-hospital procedures, medications, length of stay and vial status at discharge. The subset of eligible, consenting patients randomized in the trial will have more detailed in-hospital information ed and will be followed for at least six months post MI with telephone interviews at 2 weeks post discharge, 6 months post-MI and (if recruited early) 12 months post-MI. The modified Naughton test will be completed at 6 months post-MI. A final telephone interview will be completed with a proxy if the patient expires before the next scheduled contact. An early stopping rule is proposed with interim analyses to monitor protocol adherence. The final analysis will be according to intention to treat. Some subgroup analyses within treatment groups are proposed to identify important subgroups most or least likely to benefit from ERV and other therapeutic combinations.
Keywords: cardiogenic shock, coronary bypass, heart revascularization, human therapy evaluation, intraluminal angioplasty, myocardial infarction, clinical trial, fibrinolytic agent, human mortality, medical complication, patient /disease registry, quality of life, sex difference, angiography, human subject
Project start date: 1994-09-15
Project end date: 1999-08-31
5R01HL050020-02 (1995): $798945
1R01HL050020-01A2 (1994): $837728
5R01HL050020-05 (1998): $243263
5R01HL050020-04 (1997): $578104
Occluded Artery Trial: Long Term Follow-Up
Judith S Hochman, Professor Of Medicine
New York University School Of Medicine New York, Ny 10016
Grant 2U01HL062509-06A1 from National Heart, Lung, And Blood Institute IRG: ZHL1
Abstract: The Occluded Artery Trial (OAT) is an NHLBI-funded international, multicenter, randomized trial testing the hypothesis that percutaneous coronary intervention with optimal medical therapy is superior in reducing clinical events compared to optimal medical therapy alone in stable, but high-risk, post-myocardial infarction patients. OAT patients have totally occluded infarct-related arteries 3-28 days after myocardial infarction (Ml) and at least one additional high risk feature, either reduced left ventricular function (ejection fraction < 50%) or proximal coronary artery occlusion. Patients were randomized between 2000 and 2005 to either medical management or medical management plus percutaneous coronary intervention and stenting. The primary endpoint was a composite of death, class IV congestive heart failure (CHF) and recurrent Ml. After an average of three years of follow up of 2,166 enrolled patients, there was no significant difference between the treatment groups for the primary endpoint. This application for a competitive renewal proposes A) to extend follow up by an additional 3 years to achieve an average follow up of approximately 6 years on the OAT cohort to examine late trends in events and quality of life and B) to perform additional in depth analyses on the original OAT cohort followed by 3 years. Extended follow up will also increase power to examine prespecified subgroups. Extension of follow up in OAT is designed to provide the medical community with definitive data on the risks and benefits of a strategy of routine PCI of persistently occluded infarct-related arteries in stable patients last post-Mi. OAT has over 200 participating clinical sites, a Clinical Coordinating Center (CCC) at New York University Medical School, a Co-CCC at Mount Sinai Medical Center (Miami), a Data Coordinating Center (DCC) at Maryland Medical Research Institute and an Economics and Quality of Life Coordinating Center at Duke Clinical Research Institute.
Keywords: artery occlusion, human therapy evaluation, intraluminal angioplasty, longitudinal human study, myocardial infarction, ACE inhibitor, aspirin, beta adrenergic agent, blood vessel prosthesis, cardiovascular disorder epidemiology, clinical trial, combination therapy, cooperative study, health care cost /financing, heart disorder chemotherapy, quality of life, reperfusion, clinical research, human subject, patient oriented research
Project start date: 1999-09-30
Project end date: 2011-05-31
2U01HL062509-06A1 (2007): $842231
OCCLUDED ARTERY TRIAL--CLINICAL COORDINATING CENTER
Judith S Hochman, Professor Of Medicine
New York University School Of Medicine New York, Ny 10016
Grant 3U01HL062509-05S1 from National Heart, Lung, And Blood Institute IRG: ZHL1
Abstract: Background. The benefits of establishing early coronary reperfusion in acute myocardial infarction (MI) have now been unequivocally established. However, current pharmacological strategies fail to achieve effective reperfusion in 30% or more of patients, and many patients with occluded infarct arteries do not meet current criteria for use of these agents. Early angioplasty, an effective reperfusion method, is available to a small proportion of potentially eligible US acute MI patients. Hence, a substantial number of acute MI patients pass the time when reperfusion therapy has any documented benefit (12-24 hours) with a persistently closed infarct vessel. Several lines of experimental and clinical evidence suggest that late reperfusion of these patients could provide clinically significant reductions in mortality and morbidity. Hypothesis The central hypothesis of the Open Artery Trial is that opening an occluded infarct artery 3-21 days after an acute MI in high-risk asymptomatic patients (ejection fraction less than 50% or proximal occlusion of a large coronary artery) will reduce the composite endpoint of mortality, recurrent MI, and hospitalization for NYHA class IV congestive hear failure (CHF) over an average three year follow-up. Specific aims. The study will be a prospective clinical trial with 3,200 patients randomly allocated in equal proportions to two tretments arms over two years. One treatment will consist of conventional medical management (including aspirin, beta blockers, ACE inhibitors, and risk factor modification). The experimental treatment will consist of conventional medical therapy plus percutaneous coronary intervention and coronary stenting. Clinical outcomes will be compared using an intention-to-treat analysis. We have one primary specific aim 1) To compare the composite outcome of all-cause mortality, non-fetal MI and hospitalization of NYHA class IV CHF based on an average three year follow-up among patients assigned to the two treatments. We have three secondary specific aims 1) To compare the individual components of the study composite primary endpoint in the two treatment arms. 2) To compare the medical costs of the two treatments and assess the cost effectiveness of percutaneous revascularization in the study population. 3) To compare health-related quality of life in the two treatment groups. Operations. The Luke s-Roosevelt Hospital in New York City. The Data Coordinating Center (DCC) is at the Maryland Medical Research Institute. The Economics and Quality of Life Coordinating Center is at Duke University. The Angiographic Core Laboratory is at the University of British Columbia.
Keywords: artery occlusion, human therapy evaluation, intraluminal angioplasty, myocardial infarction, ACE inhibitor, aspirin, beta adrenergic agent, blood vessel prosthesis, cardiovascular disorder epidemiology, clinical trial, combination therapy, cooperative study, health care cost /financing, heart disorder chemotherapy, quality of life, reperfusion, clinical research, human subject, patient oriented research
Project start date: 1999-09-30
Project end date: 2007-05-31
3U01HL062509-05S1 (2006): $638138
7U01HL062509-05 (2003): $908004
1U01HL062509-01A1 (1999): $3264308
EARLY REVASCULARIZATION FOR CARDIOGENIC SHOCK
Judith S Hochman, Professor Of Medicine
St. Luke s-roosevelt Inst For Hlth Scis New York, Ny 10019
Grant 5R01HL050020-03 from National Heart, Lung, And Blood Institute IRG: CLTR
Project start date: 1994-09-15
Project end date: 1999-08-31
5R01HL050020-03 (1996): $784319