Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000552
Status:
COMPLETED
Last Update Posted:
2014-03-04
First Post:
1999-10-27
Brief Title:
Shock Trial Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock
Sponsor:
Carelon Research
Organization:
Carelon Research
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
BACKGROUND
Approximately 75 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
Approximately 75 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL049970 | NIH | None | httpsreporternihgovquickSearchR01HL049970 |