NCT00725088

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

August 25, 2008

Status Verified

July 1, 2008

Enrollment Period

2 years

First QC Date

July 28, 2008

Last Update Submit

August 22, 2008

Conditions

Acute Myocardial Infarction

Keywords

ST-Elevated Myocardial InfarctionExercise TrainingRehabilitation

Outcome Measures

Primary Outcomes (1)

  • Cardiac mortality

    one year

Secondary Outcomes (1)

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

    one year

Study Arms (2)

1

EXPERIMENTAL

exercise training group

Behavioral: Exercise training

2

NO INTERVENTION

control group

Interventions

Exercise trainingBEHAVIORAL

Exercise training

1

Eligibility Criteria

Age35 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100083, China

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Exercise

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Wei Gao, MD

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Gao, MD

CONTACT

86-10-82268200dr_gaowei@yahoo.com

Fuchun Zhang

CONTACT

86-10-62017691zhang.fuchun@medmail.com.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 28, 2008

First Posted

July 30, 2008

Study Start

December 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2010

Last Updated

August 25, 2008

Record last verified: 2008-07

Locations

CN(1)