Acute Myocardial InfarctionAIDNCT06406218
The Impact of Phase I Cardiac Rehabilitation on the Prognosis of AMI Patients After PCI
A study testing Phase I Cardiac Rehabilitation Exercise Training in people with Acute Myocardial Infarction and Phase I Cardiac Rehabilitation, run by Han Yaling, MD at 1 site in China.
Trial summary
Previous research has confirmed that patients undergoing percutaneous coronary intervention (PCI) can benefit from cardiac rehabilitation programs. However, there is a paucity of studies on Phase I cardiac rehabilitation commenced within three days following PCI in patients with acute myocardial infarction (AMI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction, Phase I Cardiac Rehabilitation
- What is being tested?
- Phase I Cardiac Rehabilitation Exercise Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- 1 siteChina
- Study dates
- 24 Apr 2024to 30 Apr 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with AMI (including STEMI and NSTEMI) who were treated in the CCU (Coronary Care Unit) for more than 12 hours after emergency PCI;
- Patients who are expected to meet the discharge criteria without the need for repeat PCI during the current hospital stay after PCI;
- No chest pain episodes within 8 hours, with no recurrence of myocardial infarction; remained hemodynamically stable;
- No further increase in serum levels of cardiac biomarkers such as Creatine Kinase -MB (CK-MB) and cardiac troponins (cTn).
Who cannot join
- Patients with Killip class III or higher, or symptoms and signs of acute pulmonary edema and respiratory distress;
- Malignant arrhythmias that cause hemodynamic instability and potentially life-threatening conditions;
- Mechanical lesions such as ventricular wall rupture, valve or tendon rupture;
- Patients who have not yet been weaned off ECMO, IABP, temporary pacemakers, CRRT;
- Patients with liver or kidney dysfunction (transaminase exceeded three times the upper limit of normal; EGFR<30 ml/(min·1.73m^2)) or advanced malignant tumors;
- Patients who cannot undergo exercise rehabilitation due to orthopedic or psychiatric diseases;
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- Patients with language impairment;
- Patients currently undergoing systematic training or participating in other clinical trials without reaching the primary endpoint collection time;
- Researchers believe that patients are not suitable for participation in this study or have not obtained an informed consent form.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
General Hospital of Northern Theater Command
Shenyang, Liaoning, 110016
Ya-Ling Han, PhD, +86 024-28897309, hanyaling@263.net
About this study
Official title: The Impact of Phase I Cardiac Rehabilitation on the Prognosis of Acute Myocardial Infarction (AMI) Patients After Percutaneous Coronary Intervention (PCI): A Single-Center, Randomized Controlled Study
Previous research has confirmed that patients undergoing percutaneous coronary intervention (PCI) can benefit from cardiac rehabilitation programs. However, there is a paucity of studies on Phase I cardiac rehabilitation commenced within three days following PCI in patients with acute myocardial infarction (AMI). Consequently, the objective of the study is to demonstrate whether Phase I cardiac rehabilitation can improve the prognosis at 12 months when compared with the control group. The primary endpoint is the Seattle Angina Questionnaire (SAQ) score at 12 months for the patients. The principal hypothesis of the study is that Phase I cardiac rehabilitation will improve the long-term prognosis for AMI patients at 12 months after PCI.
- Being tested
- Phase I Cardiac Rehabilitation Exercise Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase I Cardiac Rehabilitation Exercise TrainingBehavioural
- In the morning, take a supine position and perform straight leg raises with each leg individually, lifting to a height of 30° and holding for 3-5 seconds. Raise both arms to the side of the head to a 90° angle and hold for 5-10 seconds. Inhale deeply when exerting force and exhale slowly when lowering. Alternate between leg lifts and arm raises, performing 5 sets per session. Adjust intensity based on individual condition and may be repeated. In the afternoon, sit beside the bed for 5 minutes. B) After transitioning to secondary care according to the patient's condition, stand beside the bed for 5 minutes in the morning; in the afternoon, march in place beside the bed for 5 minutes. C) Walk beside the bed for 10 minutes per session, twice a day. D) Move around and doing activities under supervision inside the ward, 10 minutes per session, twice a day.
Spend approximately one day at each level, gradually progressing the exercise to the patient's tolerance level.
| Study group | Role | What they receive |
|---|---|---|
| Phase I Cardiac Rehabilitation Exercise Training | Experimental | Not described Receives: Behavioral: Phase I Cardiac Rehabilitation Exercise Training |
| Guideline control | No intervention | During hospitalization, patients assigned to the guideline control only receive routine medication treatment according to the guidelines, without any exercise intervention or education. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seattle Angina Questionnaire (SAQ)
Seattle Angina Questionnaire Score (from 0 to 500) higher scores mean a better outcome.
The assessment consists of five specific dimensions, with each dimension scored on a scale ranging from 0 to 100.
- Degree of physical activity limitation.
- Stable angina status.
- Frequency of angina attacks.
- Satisfaction with treatment.
- Level of disease awareness.
Measured: 6-month and 12-month
Secondary outcomes (3)
6 minutes walking distance
Measured: 6-month and 12-month
Left ventricular ejection fraction
The percentage of the left ventricular stroke volume relative to the left ventricular end-diastolic volume(%).
Measured: 6-month
MACCE
All-cause death, myocardial infarction, stroke, revascularization again
Measured: 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start24 Apr 2024
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Han Yaling, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Han Yaling, MD, Shenyang Northern Hospital
- Investigators
- Ya-Ling Han, PhD, Principal investigator, Department of Cardiology, General Hospital of Northern Theater Command, Shenyang 110016, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406218
- Sponsor's protocol ID
- AID
- Acronym
- AID
- Status last verified
- May 2024
- First submitted
- 29 Apr 2024
- Last updated
- 9 May 2024
- Results posted
- 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 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Phase I Cardiac Rehabilitation on the Prognosis of Acute Myocardial Infarction (AMI) Patients After Percutaneous Coronary Intervention (PCI): A Single-Center, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06406218
- Acronym / sponsor ID
- AID / AID
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Han Yaling, MDUniversity, hospital or other
- Study start
- 24 Apr 2024 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 9 May 2024 (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.
Previous research has confirmed that patients undergoing percutaneous coronary intervention (PCI) can benefit from cardiac rehabilitation programs. However, there is a paucity of studies on Phase I cardiac rehabilitation commenced within three days following PCI in patients with acute myocardial infarction (AMI). Consequently, the objective of the study is to demonstrate whether Phase I cardiac rehabilitation can improve the prognosis at 12 months when compared with the control group. The primary endpoint is the Seattle Angina Questionnaire (SAQ) score at 12 months for the patients. The principal hypothesis of the study is that Phase I cardiac rehabilitation will improve the long-term prognosis for AMI patients at 12 months after PCI.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase I Cardiac Rehabilitation Exercise Training | Experimental | Behavioral: Phase I Cardiac Rehabilitation Exercise Training |
| Guideline control | No intervention | –During hospitalization, patients assigned to the guideline control only receive routine medication treatment according to the guidelines, without any exercise intervention or education. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with AMI (including STEMI and NSTEMI) who were treated in the CCU (Coronary Care Unit) for more than 12 hours after emergency PCI;
- Patients who are expected to meet the discharge criteria without the need for repeat PCI during the current hospital stay after PCI;
- No chest pain episodes within 8 hours, with no recurrence of myocardial infarction; remained hemodynamically stable;
- No further increase in serum levels of cardiac biomarkers such as Creatine Kinase -MB (CK-MB) and cardiac troponins (cTn).
Key exclusion criteria (9 listed)
- Patients with Killip class III or higher, or symptoms and signs of acute pulmonary edema and respiratory distress;
- Malignant arrhythmias that cause hemodynamic instability and potentially life-threatening conditions;
- Mechanical lesions such as ventricular wall rupture, valve or tendon rupture;
- Patients who have not yet been weaned off ECMO, IABP, temporary pacemakers, CRRT;
- Patients with liver or kidney dysfunction (transaminase exceeded three times the upper limit of normal; EGFR<30 ml/(min·1.73m^2)) or advanced malignant tumors;
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 I Cardiac Rehabilitation Exercise TrainingA) In the morning, take a supine position and perform straight leg raises with each leg individually, lifting to a height of 30° and holding for 3-5 seconds. Raise both arms to the side of the head to a 90° angle and hold for 5-10 seconds. Inhale deeply when exerting force and exhale slowly when lowering. Alternate between leg lifts and arm raises, performing 5 sets per session. Adjust intensity based on individual condition and may be repeated. In the afternoon, sit beside the bed for 5 minutes. B) After transitioning to secondary care according to the patient's condition, stand beside the bed for 5 minutes in the morning; in the afternoon, march in place beside the bed for 5 minutes. C) Walk beside the bed for 10 minutes per session, twice a day. D) Move around and doing activities under supervision inside the ward, 10 minutes per session, twice a day. Spend approximately one day at each level, gradually progressing the exercise to the patient's tolerance level. | Behavioural | Phase I Cardiac Rehabilitation Exercise Training |
Primary outcome
Seattle Angina Questionnaire (SAQ)
Time frame: 6-month and 12-month
Seattle Angina Questionnaire Score (from 0 to 500) higher scores mean a better outcome. The assessment consists of five specific dimensions, with each dimension scored on a scale ranging from 0 to 100. 1. Degree of physical activity limitation. 2. Stable angina status. 3. Frequency of angina attacks. 4. Satisfaction with treatment. 5. Level of disease awareness.
3 secondary outcomes
6 minutes walking distance
Time frame: 6-month and 12-month
Left ventricular ejection fraction
Time frame: 6-month
MACCE
Time frame: 12-month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 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.
Ya-Ling Han, PhD principal investigator
Department of Cardiology, General Hospital of Northern Theater Command, Shenyang 110016, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phase I Cardiac Rehabilitation Exercise Training in people with Acute Myocardial Infarction and Phase I Cardiac Rehabilitation, run by Han Yaling, MD 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 9 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 9 May 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 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 Ya-Ling Han, PhD (+86 024-28897309, hanyaling@263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seattle Angina Questionnaire (SAQ) (time frame: 6-month and 12-month). 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 9 May 2024.