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 abstracted 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.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project (R01)
Project #
1R01HL050020-01A2
Application #
2226100
Study Section
Clinical Trials Review Committee (CLTR)
Project Start
1994-09-15
Project End
1999-08-31
Budget Start
1994-09-15
Budget End
1995-08-31
Support Year
1
Fiscal Year
1994
Total Cost
Indirect Cost
Name
St. Luke's-Roosevelt Institute for Health Sciences
Department
Type
DUNS #
City
New York
State
NY
Country
United States
Zip Code
10019
Jeger, Raban V; Urban, Philip; Harkness, Shannon M et al. (2011) Early revascularization is beneficial across all ages and a wide spectrum of cardiogenic shock severity: A pooled analysis of trials. Acute Card Care 13:14-20
Ramanathan, Krishnan; Farkouh, Michael E; Cosmi, John E et al. (2011) Rapid complete reversal of systemic hypoperfusion after intra-aortic balloon pump counterpulsation and survival in cardiogenic shock complicating an acute myocardial infarction. Am Heart J 162:268-75
Sleeper, Lynn A; Reynolds, Harmony R; White, Harvey D et al. (2010) A severity scoring system for risk assessment of patients with cardiogenic shock: a report from the SHOCK Trial and Registry. Am Heart J 160:443-50
French, John K; Harkness, Shannon; Sleeper, Lynn et al. (2009) Cardiogenic shock without flow-limiting angiographic coronary artery disease: (from the Should We Emergently Revascularize Occluded Coronary Arteries for Cardiogenic Shock Trial and Registry). Am J Cardiol 104:24-8
Lee, Michael S; Tseng, Chi-Hong; Barker, Colin M et al. (2008) Outcome after surgery and percutaneous intervention for cardiogenic shock and left main disease. Ann Thorac Surg 86:29-34
Apolito, Renato A; Greenberg, Mark A; Menegus, Mark A et al. (2008) Impact of the New York State Cardiac Surgery and Percutaneous Coronary Intervention Reporting System on the management of patients with acute myocardial infarction complicated by cardiogenic shock. Am Heart J 155:267-73
Jeger, Raban V; Lowe, April M; Buller, Christopher E et al. (2007) Hemodynamic parameters are prognostically important in cardiogenic shock but similar following early revascularization or initial medical stabilization: a report from the SHOCK Trial. Chest 132:1794-803
Jeger, Raban V; Assmann, Susan F; Yehudai, Loran et al. (2007) Causes of death and re-hospitalization in cardiogenic shock. Acute Card Care 9:25-33
Berkowitz, M Joshua; Picard, Michael H; Harkness, Shannon et al. (2006) Echocardiographic and angiographic correlations in patients with cardiogenic shock secondary to acute myocardial infarction. Am J Cardiol 98:1004-8
Hochman, Judith S; Sleeper, Lynn A; Webb, John G et al. (2006) Early revascularization and long-term survival in cardiogenic shock complicating acute myocardial infarction. JAMA 295:2511-5

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