Study of Rehabilitation Therapy on Patients After Acute M... | NCT00725088

Studies
Study of Rehabilitation Therapy on Patients After Acute Myocardial Infarction

NCT00725088

Sponsor

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

Status

Unknown status

Last Update Posted

Aug 25, 2008Estimated

Enrollment

300Estimated

Phase

Not Applicable

Conditions

Acute Myocardial Infarction

Interventions

Exercise training

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2006

Primary Completion Date

Dec 2008Estimated

Completion Date

Dec 2010Estimated

First Submitted Date

Jul 28, 2008

First Submission Date that Met QC Criteria

Jul 29, 2008

First Posted Date

Jul 30, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 22, 2008

Last Update Posted Date

Aug 25, 2008Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Ministry of Science and Technology of the People´s Republic of ChinaOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	exercise training group	Behavioral: Exercise training
2	No Intervention	control group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exercise training	Behavioral	Exercise training	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cardiac mortality		one year

Secondary Outcomes

Measure	Description	Time Frame
Non-fatal reinfarction, revascularization(PCI/CABG), ischemic stroke, unstable angina pectoris needs for hospitalization, severe heart failure needs for hospitalization		one year

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

74 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wei Gao, MD	Contact	86-10-82268200		dr_gaowei@yahoo.com
Fuchun Zhang	Contact	86-10-62017691	8203	zhang.fuchun@medmail.com.cn

Overall Officials

Name	Affiliation	Role
Wei Gao, MD	Peking University Third Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University Third Hospital	Recruiting	Beijing	Beijing Municipality	100083	China

Condition Browse Module

MeSH Terms

ID	Term
D000072657	ST Elevation Myocardial Infarction

Ancestor Terms

ID	Term
D009203	Myocardial Infarction
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided