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Shock Trial: Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00000552
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : March 4, 2014
National Heart, Lung, and Blood Institute (NHLBI)
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Brief 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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Infarction Myocardial Ischemia Shock, Cardiogenic Procedure: angioplasty, transluminal, percutaneous coronary Procedure: coronary artery bypass Drug: thrombolytic therapy Phase 3

Detailed Description:


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.


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.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Study Start Date : September 1994
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Men and women with myocardial infarction and cardiogenic shock.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00000552

Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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OverallOfficial: Lynn Sleeper New England Research Institute, Inc.


Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00000552    
Other Study ID Numbers: 96
R01HL049970 ( U.S. NIH Grant/Contract )
First Posted: October 28, 1999    Key Record Dates
Last Update Posted: March 4, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
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Heart Diseases
Myocardial Infarction
Coronary Disease
Myocardial Ischemia
Shock, Cardiogenic
Cardiovascular Diseases
Pathologic Processes
Vascular Diseases
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action