Acute Myocardial InfarctionNCT00725088
Study of Rehabilitation Therapy on Patients After Acute Myocardial Infarction
A study testing Exercise training in people with Acute Myocardial Infarction, run by Ministry of Science and Technology of the People´s Republic of China at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 35 to 74 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Dec 2006to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100083
About this study
The purpose of this study is to determine whether exercise rehabilitation can reduce mortality, reinfarction or heart failure of patients after acute myocardial infarction.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Exercise training
- Keywords
- ST-Elevated Myocardial Infarction, Exercise Training, Rehabilitation
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingBehavioural
Exercise training
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | exercise training group Receives: Behavioral: Exercise training |
| 2 | No intervention | control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac mortality
Measured: 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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2008 (estimated)
- Study startDec 2006
- Primary completionDec 2008 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Science and Technology of the People´s Republic of China
- Sponsor type
- Other government
- Investigators
- Wei Gao, MD, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00725088
- Sponsor's protocol ID
- 2006BAI01A02-10
- Status last verified
- Jul 2008
- First submitted
- 28 Jul 2008
- Last updated
- 25 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Rehabilitation Therapy on Patients After Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00725088
- Acronym / sponsor ID
- 2006BAI01A02-10
- Conditions
- Acute Myocardial Infarction
- Keywords
- ST-Elevated Myocardial Infarction, Exercise Training, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ministry of Science and Technology of the People´s Republic of ChinaOther government
- Study start
- Dec 2006
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 30 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether exercise rehabilitation can reduce mortality, reinfarction or heart failure of patients after acute myocardial infarction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Exercise trainingexercise training group |
| 2 | No intervention | –control group |
Who may qualify
- Ages
- 35 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise trainingExercise training | Behavioural | 1 |
Primary outcome
Cardiac mortality
Time frame: one year
1 secondary outcome
Non-fatal reinfarction, revascularization(PCI/CABG), ischemic stroke, unstable angina pectoris needs for hospitalization, severe heart failure needs for hospitalization
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Gao, MD principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Acute Myocardial Infarction, run by Ministry of Science and Technology of the People´s Republic of China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Gao, MD (86-10-82268200, dr_gaowei@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac mortality (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2008.