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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00725088
Other study ID # 2006BAI01A02-10
Secondary ID
Status Recruiting
Phase N/A
First received July 28, 2008
Last updated August 22, 2008
Start date December 2006
Est. completion date December 2010

Study information

Verified date July 2008
Source Ministry of Science and Technology of the People´s Republic of China
Contact Wei Gao, MD
Phone 86-10-82268200
Email dr_gaowei@yahoo.com
Is FDA regulated No
Health authority China: Ministry of Health
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether exercise rehabilitation can reduce mortality, reinfarction or heart failure of patients after acute myocardial infarction.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date December 2010
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 35 Years to 74 Years
Eligibility Inclusion Criteria:

- Clinical diagnosis of ST-elevated myocardial infarction

- Heart function class I-II(killip classification)

- Agree to take cardiopulmonary exercise testing before discharge

- Signature of the informed consent document

Exclusion Criteria:

- History of myocardial infarction

- Acute myocardial infarction with severe complications(such as pulmonary edema, severe cardiac arrhythmia or cardiogenic shock)

- Atrial fibrillation

- Other severe diseases, such as HIV infection, malignant tumor or chronic diseases of liver, kidney or pulmonary

- Not be capable of exercise training

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Behavioral:
Exercise training
Exercise training

Locations

Country Name City State
China Peking University Third Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Ministry of Science and Technology of the People´s Republic of China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cardiac mortality one year Yes
Secondary Non-fatal reinfarction, revascularization(PCI/CABG), ischemic stroke, unstable angina pectoris needs for hospitalization, severe heart failure needs for hospitalization one year Yes
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