Acute Myocardial InfarctionNCT05661825
Cardiac Rehabilitation for the Patients With Acute Myocardial Infarction
An observational study of Acute Myocardial Infarction, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
The benefits of cardiac rehabilitation include improving exercise tolerance and quality of life. However the attending rate of the patients with acute myocardial infarction was low according to the previous studies. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- phase II cardiac rehabilitation
- How many people
- 850 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Feb 2023to 30 Oct 2023
- Phase
- Observational
- 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 20 years and older
- All sexes
- Adult, Older adult
Study population: Acute myocardial infarction
Who may be able to join
- Cased diagnosed with acute myocardial infarction at emergent department and admitted
- Age over 20 years old
Who cannot join
- AAD cases after admission to ER or the general ward
- Cases died within admission.
- Cases refused the treatments.-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy and Related Factors in Phase II Cardiac Rehabilitation for the Patients With Acute Myocardial Infarction
The benefits of cardiac rehabilitation include improving exercise tolerance and quality of life. However the attending rate of the patients with acute myocardial infarction was low according to the previous studies. This is a retrospective chart review study collecting the basic characteristics of the patients diagnosed with acute myocardial infarction of Wang-Fang Hospital (from Jan 1, 2012 to June 30, 2021). The aims of the studies are to investigate the related issues of cardiac rehabilitation including (1) attending rate (2) the efficacy of exercise training (3) the factors that limit the participation of the training programs.
- Conditions
- Acute Myocardial Infarction
- Being tested
- phase II cardiac rehabilitation
- Keywords
- Acute myocardial infarction, Cardiac rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phase II cardiac rehabilitationOther
Phase II cardiac rehabilitation was provided in the the department of physical medicine and rehabilitation in Wan Fang Hospital. The programs are two times a week, one session for 30 minutes (30 sessions in total). The training programs are focused on aerobic training with bicycles. The training intensity is calculated with 40% to 80% oxygen consumption reserve from the result of cardiopulmonary exercise test. In case of safety, heart rate, blood pressure, EKG and rate of perceived exertion will be monitored during training.
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with acute myocardial infarction in the emergent department | The cases being admitted to the Emergent Department and than transferred to the general ward due to the diagnosis of acute myocardial infarction were included in the study (from Jan 1, 2012 to Jun 30, 2022). The age of these cases must be older than or equal to 20 years old. Receives: Other: phase II cardiac rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of maximal oxygen consumption after intervention
The subjects received cardiopulmonary exercise tests before and after training.
Measured: Baseline, 6 weeks after training, 16 weeks after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start1 Feb 2023
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 850 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shiauyee Chen, Master, Principal investigator, Department of physical medicine and rehabilitation, Wan Fang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05661825
- Sponsor's protocol ID
- TMU-JIRB N202207042
- Status last verified
- May 2024
- First submitted
- 14 Dec 2022
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Related Factors in Phase II Cardiac Rehabilitation for the Patients With Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT05661825
- Acronym / sponsor ID
- TMU-JIRB N202207042
- Conditions
- Acute Myocardial Infarction
- Keywords
- Acute myocardial infarction, Cardiac rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 850 participants (actual)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 22 Dec 2022 (actual)
- 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 benefits of cardiac rehabilitation include improving exercise tolerance and quality of life. However the attending rate of the patients with acute myocardial infarction was low according to the previous studies. This is a retrospective chart review study collecting the basic characteristics of the patients diagnosed with acute myocardial infarction of Wang-Fang Hospital (from Jan 1, 2012 to June 30, 2021). The aims of the studies are to investigate the related issues of cardiac rehabilitation including (1) attending rate (2) the efficacy of exercise training (3) the factors that limit the participation of the training programs.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with acute myocardial infarction in the emergent department | – | Other: phase II cardiac rehabilitationThe cases being admitted to the Emergent Department and than transferred to the general ward due to the diagnosis of acute myocardial infarction were included in the study (from Jan 1, 2012 to Jun 30, 2022). The age of these cases must be older than or equal to 20 years old. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Acute myocardial infarction
Key inclusion criteria (2 listed)
- Cased diagnosed with acute myocardial infarction at emergent department and admitted
- Age over 20 years old
Key exclusion criteria (3 listed)
- AAD cases after admission to ER or the general ward
- Cases died within admission.
- Cases refused the treatments.-
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 |
|---|---|---|
| phase II cardiac rehabilitationPhase II cardiac rehabilitation was provided in the the department of physical medicine and rehabilitation in Wan Fang Hospital. The programs are two times a week, one session for 30 minutes (30 sessions in total). The training programs are focused on aerobic training with bicycles. The training intensity is calculated with 40% to 80% oxygen consumption reserve from the result of cardiopulmonary exercise test. In case of safety, heart rate, blood pressure, EKG and rate of perceived exertion will be monitored during training. | Other | Patients diagnosed with acute myocardial infarction in the emergent department |
Primary outcome
Changes of maximal oxygen consumption after intervention
Time frame: Baseline, 6 weeks after training, 16 weeks after training
The subjects received cardiopulmonary exercise tests before and after training.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Shiauyee Chen, Master principal investigator
Department of physical medicine and rehabilitation, Wan Fang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 25 Jun 2024. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of maximal oxygen consumption after intervention (time frame: Baseline, 6 weeks after training, 16 weeks after training). 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 Jun 2024.