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Study of Rehabilitation Therapy on Patients After Acute Myocardial Infarction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by Ministry of Science and Technology of the People´s Republic of China.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Ministry of Science and Technology of the People´s Republic of China
ClinicalTrials.gov Identifier:
NCT00725088
First received: July 28, 2008
Last updated: August 22, 2008
Last verified: July 2008
History of Changes
  Purpose

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


Condition Intervention
Acute Myocardial Infarction
 Behavioral: Exercise training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Rehabilitation Therapy on Patients After Acute Myocardial Infarction

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ministry of Science and Technology of the People´s Republic of China:

Primary Outcome Measures:
  • Cardiac mortality [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Non-fatal reinfarction, revascularization(PCI/CABG), ischemic stroke, unstable angina pectoris needs for hospitalization, severe heart failure needs for hospitalization [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: December 2006
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
exercise training group
 Behavioral: Exercise training
Exercise training
No Intervention: 2
control group

  Eligibility

Ages Eligible for Study:   35 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00725088

Contacts
Contact: Wei Gao, MD 86-10-82268200 dr_gaowei@yahoo.com
Contact: Fuchun Zhang 86-10-62017691 ext 8203 zhang.fuchun@medmail.com.cn

Locations
China, Beijing
Peking University Third Hospital Recruiting
Beijing, Beijing, China, 100083
Sponsors and Collaborators
Ministry of Science and Technology of the People´s Republic of China
Investigators
Principal Investigator: Wei Gao, MD Peking University Third Hospital
  More Information

No publications provided

Responsible Party: Yong Huo, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT00725088     History of Changes
Other Study ID Numbers: 2006BAI01A02-10
Study First Received: July 28, 2008
Last Updated: August 22, 2008
Health Authority: China: Ministry of Health

Keywords provided by Ministry of Science and Technology of the People´s Republic of China:
ST-Elevated Myocardial Infarction
Exercise Training
Rehabilitation

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013