Shock Trial: Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock.
Condition: Cardiovascular Diseases; Coronary Disease; Heart Diseases; Myocardial Infarction; Myocardial Ischemia; Shock, Cardiogenic
MeSH terms: Cardiovascular Diseases; Heart Diseases; Myocardial Infarction; Coronary Disease; Myocardial Ischemia; Shock, Cardiogenic; Infarction; Shock; Ischemia
Study type: Interventional
Phase: Phase 3

Summary: 
      To test if early revascularization, primarily with angioplasty (PTCA) or bypass surgery
      (CABG), reduced all-cause in-hospital mortality from cardiogenic shock compared to
      conventional treatment, including thrombolysis.
    

Detailed description: 
      BACKGROUND:

      Approximately 7.5 percent of all acute myocardial infarctions which are diagnosed in an
      emergency room or in-hospital lead to cardiogenic shock and an in-hospital death rate of 70
      to 80 percent, usually within one to two days of diagnosis of cardiogenic shock. The high
      death rate has not changed in the last two decades. Non-random clinical series and animal
      studies suggest that rapid revascularization following cardiogenic shock complicating acute
      myocardial infarction 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.

      DESIGN NARRATIVE:

      Randomized, multicenter, Phase III, controlled clinical trial. Patients with shock due to
      left ventricular failure complicating myocardial infarction were randomly assigned to
      emergency revascularization or initial medical stabilization. Revascularization was
      accomplished by either coronary-artery bypass grafting or angioplasty. A total of 152
      patients were randomized to early revascularization and 150 patients to conventional therapy
      consisting of thrombolytics and a possible late attempt at revascularization. Intraaortic
      balloon counterpulsation was performed in 86 percent of the patients in both groups. The
      primary endpoint was mortality from all causes at 30 days. Secondary endpoints included
      all-cause mortality at six months and assessment of the quality of life in survivors after
      discharge.

      All patients with a clinically suspected diagnosis of cardiogenic shock complicating
      myocardial infarction formed a registry, with limited information collected on in-hospital
      procedures, medications, length of stay and vital status at discharge.

      The study has been extended through June, 2005 for patient follow-up and data analyses.
      Long-term survival rates (6 to 11 years post-MI) will be estimated and the quality of life of
      survivors of acute MI complicated by cardiogenic shock will be studied. Extended trial data
      analyses will be conducted: a) To determine the early echocardiographic parameters which are
      associated with one year survival in cardiogenic shock patients, and to assess the
      interaction of these parameters with early revascularization; b) To examine differences in
      disease course and patient outcome as a function of age, gender, national practice, and
      changes in serial hemodynamic measurements, as well as to better characterize the related
      conditions and complications of cardiogenic shock.
    

Intervention name(s): angioplasty, transluminal, percutaneous coronary; coronary artery bypass; thrombolytic therapy
Intervention type(s): Procedure; Procedure; Drug
Intervention MeSH terms: Fibrinolytic Agents
Allocation: Randomized
Primary purpose: Treatment