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Study of Rehabilitation Therapy on Patients After Acute Myocardial Infarction

Primary Purpose

Acute Myocardial Infarction

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Exercise training
Sponsored by
Ministry of Science and Technology of the People´s Republic of China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring ST-Elevated Myocardial Infarction, Exercise Training, Rehabilitation

Eligibility Criteria

35 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking University Third HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

exercise training group

control group

Outcomes

Primary Outcome Measures

Cardiac mortality

Secondary Outcome Measures

Non-fatal reinfarction, revascularization(PCI/CABG), ischemic stroke, unstable angina pectoris needs for hospitalization, severe heart failure needs for hospitalization

Full Information

First Posted
July 28, 2008
Last Updated
August 22, 2008
Sponsor
Ministry of Science and Technology of the People´s Republic of China
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1. Study Identification

Unique Protocol Identification Number
NCT00725088
Brief Title
Study of Rehabilitation Therapy on Patients After Acute Myocardial Infarction
Official Title
Study of Rehabilitation Therapy on Patients After Acute Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Unknown status
Study Start Date
December 2006 (undefined)
Primary Completion Date
December 2008 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
ST-Elevated Myocardial Infarction, Exercise Training, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
exercise training group
Arm Title
2
Arm Type
No Intervention
Arm Description
control group
Intervention Type
Behavioral
Intervention Name(s)
Exercise training
Intervention Description
Exercise training
Primary Outcome Measure Information:
Title
Cardiac mortality
Time Frame
one year
Secondary Outcome Measure Information:
Title
Non-fatal reinfarction, revascularization(PCI/CABG), ischemic stroke, unstable angina pectoris needs for hospitalization, severe heart failure needs for hospitalization
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Gao, MD
Phone
86-10-82268200
Email
dr_gaowei@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fuchun Zhang
Phone
86-10-62017691
Ext
8203
Email
zhang.fuchun@medmail.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Gao, MD
Organizational Affiliation
Peking University Third Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100083
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Study of Rehabilitation Therapy on Patients After Acute Myocardial Infarction

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