Acute Myocardial InfarctionNCT04511182
Early Individualized-Exercise Based Cardiac Rehabilitation Programs in Patients With Acute Myocardial Infarction
A study testing Exercise-based cardiac rehabilitation in people with Acute Myocardial Infarction, run by RenJi Hospital at 1 site in China.
Trial summary
Acute myocardial infarction (AMI) is a life-threatening condition and a cause of functional disability. After reperfusion therapies and pharmacological strategies, patients suffered great pain physically and mentally. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Exercise-based cardiac rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2021to 1 Feb 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute myocardial infarction (AMI) within 1 months prior to recruitment.
- Complete revascularization.
- Man or non- pregnant women aged from 18 to 80 years.
Who cannot join
- Uncontrolled hypertension (systolic blood pressure/diastolic blood pressure >160/100 mmHg)，or symptomatic hypotension.
- Significant resting electrocardiogram abnormalities (left bundle branch block, non-specific intraventricular conduction delay, left ventricular hypertrophy, resting ST-segment depression), life-threatening cardiac arrhythmias.
- Acute myocarditis, pericarditis or acute systemic illness.
- Those who are assessed by the doctor as high-risk [12].
- Pacemaker or implantable cardioverter defibrillator.
- Any contraindication to exercise testing or exercise training or inability to complete a CPET.
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- Life-threatening diseases with limited life expectancy <3 year.
- Uncontrolled unstable angina pectoris.
- Significant valvular disease (mitral stenosis, moderate to severe mitral insufficiency, aortic stenosis, or aortic insufficiency, severe mitral / aortic regurgitation).
- Severe mental or cognitive impairment.
- Inability to follow the procedures of the study.
Trial locations and contacts
1 site in 1 country.
China1 site
RenJi Hospital, Shanghai JiaoTong University, School of Medicine
Shanghai, Shanghai Municipality, 200127
Qin Shao, M.D,Ph.D, 86-21-68385225, shaoqindr@126.com
Jun Ma, M.D,Ph.D, 86-21-68383164, drjunma@126.com
About this study
Official title: Early Individualized-exercise Based Cardiac Rehabilitation Program in Patients With a Recent Acute Myocardial Infarction (EARLYmyo-CRPⅡ): Study Protocol for a Randomised Controlled Trial
Acute myocardial infarction (AMI) is a life-threatening condition and a cause of functional disability. After reperfusion therapies and pharmacological strategies, patients suffered great pain physically and mentally. How to improve the quality of life and the prognosis in patients with AMI is a hot topic in the field of cardiac rehabilitation now. In this study, a randomized, controlled and prospective clinical trial is designed for patients with AMI to improve exercise capacity, cardiometabolic parameters, as well as quality of life by an individualized, low-cost exercise intervention we developed after evaluation by Cardiopulmonary Exercise Tests (CPET). Serial CPET are performed to prospectively measure changes in aerobic exercise capacity, and the MOS item short form health survey（SF-36）are constructed to survey life quality. What's more, echocardiography and NT-proBNP are also assessed.
Read the detailed description
Acute myocardial infarction (AMI) is a life-threatening condition and a cause of functional disability, although reperfusion therapies and pharmacological strategies have been developed dramatically. Percutaneous coronary intervention（PCI）can effectively improve the myocardial blood supply of patients, However, various degrees of reduced exercise tolerance, anxiety and depression symptoms, impaired social function may occur after PCI and then lead to the decline of their quality of life. Exercise-based cardiopulmonary rehabilitation, which has beneficial effects on physical fitness, quality of life, cardiovascular risk factors and clinical outcome, is an important part of secondary prevention for patients after an acute myocardial infarction. Despite the evidence of these beneficial effects, cardiac rehabilitation programs are still largely underutilized and the exact benefits are still less well known. In this study, a randomized, controlled and prospective clinical trial is designed for patients with AMI to improve exercise capacity, cardiometabolic parameters, as well as quality of life by an individualized, low-cost exercise intervention we developed after evaluation by Cardiopulmonary Exercise Tests (CPET) . Serial CPET are performed to prospectively measure changes in aerobic exercise capacity, and the MOS item short form health survey（SF-36）are constructed to survey life quality. What's more, echocardiography and NT-proBNP are also assessed.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Exercise-based cardiac rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise-based cardiac rehabilitationBehavioural
Exercise program is based on aerobic exercise and supplemented by strength training following the principle of gradual improvement. The type of exercise, such as walking, jogging, cycling, and the intensity of exercise which is recommended to use a cardiotach or pedometer to detect, are both defined by the results of CPET, such as METs value. Participators must be prepared for about 5-10 minutes to warm up and recover before and after exercise. 30-50 minutes a day, 5 days a week, with a total exercise time of not less than 150 minutes per week. It can be carried out in different stages according to the physical condition. After 1-3 months, the exercise prescription will be re-adjusted according to the results of reexamination.
All patients will undergo Cardiopulmonary Exercise Test, SF-36, echocardiography and laboratory examination prior to initiation of the trial, and which will be checked again after 3 months, and 6 months.
| Study group | Role | What they receive |
|---|---|---|
| exercise intervention group | Experimental | Patients will receive standard medications plus EBCR 。Education covering topics related to AMI and exercise for AMI will be implemented and any consultations on exercise prescription and disease management will be explained by a cardiac rehabilitation team consisting of cardiologists, cardiology nurses and physiotherapists. Receives: Behavioral: Exercise-based cardiac rehabilitation |
| Usual care group（control） | No intervention | Patients will receive standard medications according to national guidelines, as well as education and consultations as intervention group. However，no exercise prescription is given, |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak oxygen consumption (VO2)change
Difference in the interval changes from baseline to 3 months and 6 months in peak VO2 comparing Experimental group with control.
Measured: Baseline, 3, 6 months
Secondary outcomes (11)
Ventilatory efficiency (VE/VCO2 slope) change
Difference in the interval changes from baseline to 3 months and 6 months in Ventilatory efficiency (VE/VCO2 slope) comparing experimental group with control.
Measured: Baseline, 3, 6 months
oxygen consumption (VO2) at anaerobic threshold
Difference in the interval changes from baseline to 3 months and 6 months in VO2 at anaerobic threshold comparing Experimental group with control.
Measured: Baseline, 3, 6 months
Oxygen uptake related to work rate（ΔVO2/ΔWR）change
Difference in the interval changes from baseline to 3 months and 6 months in Oeygen uptake related to work rate（ΔVO2/ΔWR）comparing experimental group with control.
Measured: Baseline, 3, 6 months
Peak /AT Oxygen Pulse (O2-Pulse)change
Difference in the interval changes from baseline to 3 months and 6 months in Peak /AT Oxygen Pulse (O2-Pulse) comparing experimental group with control.
Measured: Baseline, 3, 6 months
Peak metabolic equivalent (MET) change
Difference in the interval changes from baseline to 3 months and 6 months in peak metabolic equivalent (MET) change comparing experimental group with control.
Measured: Baseline, 3, 6 months
Heart rate variability
Difference in the interval changes from baseline to 3 months and 6 months in Heart rate variability comparing experimental group with control.
Measured: Baseline, 3, 6 months
Body mass index（BMI）change
Difference in the interval changes from baseline to 3 months and 6 months in Body mass index（BMI）comparing experimental group with control. BMI is the value obtained by dividing body weight by height square (weight in kilograms, height in meters). BMI is a standard commonly used in the world to measure the degree of obesity and health of the human body.
Measured: Baseline, 3, 6 months
LVEF change
Difference in the interval changes from baseline to 3 months and 6 months in LVEF comparing experimental group with control.
Measured: Baseline, 3, 6 months
NT-proBNP(pg/ml)
Difference in the interval changes from baseline to 3 months and 6 months in NT-proBNP comparing Experimental group with control.
Measured: Baseline, 3, 6 months
The MOS item short form health survey(SF-36)
Difference in the interval changes from baseline to 3 months and 6 months in The MOS item short form health survey(SF-36) comparing experimental group with control.
Measured: Baseline, 3, 6 months
The occurrence and composite of major adverse cardiac events (MACE)
Major adverse cardiac events (MACE) included all-cause mortality, non-fatal myocardial infarction and coronary revascularisation. we check the outcome in 3 months and 6 months.
Measured: 3, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start1 Feb 2021 (estimated)
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Feb 2023 (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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qin Shao, M.D,Ph.D, Study chair, RenJi HospitalJun Ma, M.D,Ph.D, Study director, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04511182
- Sponsor's protocol ID
- CRP2
- Status last verified
- Jan 2021
- First submitted
- 5 Aug 2020
- Last updated
- 5 Feb 2021
- 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 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Individualized-exercise Based Cardiac Rehabilitation Program in Patients With a Recent Acute Myocardial Infarction (EARLYmyo-CRPⅡ): Study Protocol for a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04511182
- Acronym / sponsor ID
- CRP2
- Conditions
- Acute Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 13 Aug 2020 (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.
Acute myocardial infarction (AMI) is a life-threatening condition and a cause of functional disability. After reperfusion therapies and pharmacological strategies, patients suffered great pain physically and mentally. How to improve the quality of life and the prognosis in patients with AMI is a hot topic in the field of cardiac rehabilitation now. In this study, a randomized, controlled and prospective clinical trial is designed for patients with AMI to improve exercise capacity, cardiometabolic parameters, as well as quality of life by an individualized, low-cost exercise intervention we developed after evaluation by Cardiopulmonary Exercise Tests (CPET). Serial CPET are performed to prospectively measure changes in aerobic exercise capacity, and the MOS item short form health survey（SF-36）are constructed to survey life quality. What's more, echocardiography and NT-proBNP are also assessed.
Detailed description
Acute myocardial infarction (AMI) is a life-threatening condition and a cause of functional disability, although reperfusion therapies and pharmacological strategies have been developed dramatically. Percutaneous coronary intervention（PCI）can effectively improve the myocardial blood supply of patients, However, various degrees of reduced exercise tolerance, anxiety and depression symptoms, impaired social function may occur after PCI and then lead to the decline of their quality of life. Exercise-based cardiopulmonary rehabilitation, which has beneficial effects on physical fitness, quality of life, cardiovascular risk factors and clinical outcome, is an important part of secondary prevention for patients after an acute myocardial infarction. Despite the evidence of these beneficial effects, cardiac rehabilitation programs are still largely underutilized and the exact benefits are still less well known. In this study, a randomized, controlled and prospective clinical trial is designed for patients with AMI to improve exercise capacity, cardiometabolic parameters, as well as quality of life by an individualized, low-cost exercise intervention we developed after evaluation by Cardiopulmonary Exercise Tests (CPET) . Serial CPET are performed to prospectively measure changes in aerobic exercise capacity, and the MOS item short form health survey（SF-36）are constructed to survey life quality. What's more, echocardiography and NT-proBNP are also assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercise intervention group | Experimental | Behavioral: Exercise-based cardiac rehabilitationPatients will receive standard medications plus EBCR 。Education covering topics related to AMI and exercise for AMI will be implemented and any consultations on exercise prescription and disease management will be explained by a cardiac rehabilitation team consisting of cardiologists, cardiology nurses and physiotherapists. |
| Usual care group（control） | No intervention | –Patients will receive standard medications according to national guidelines, as well as education and consultations as intervention group. However，no exercise prescription is given, |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute myocardial infarction (AMI) within 1 months prior to recruitment.
- Complete revascularization.
- Man or non- pregnant women aged from 18 to 80 years.
Key exclusion criteria (11 listed)
- Uncontrolled hypertension (systolic blood pressure/diastolic blood pressure >160/100 mmHg)，or symptomatic hypotension.
- Significant resting electrocardiogram abnormalities (left bundle branch block, non-specific intraventricular conduction delay, left ventricular hypertrophy, resting ST-segment depression), life-threatening cardiac arrhythmias.
- Acute myocarditis, pericarditis or acute systemic illness.
- Those who are assessed by the doctor as high-risk [12].
- Pacemaker or implantable cardioverter defibrillator.
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-based cardiac rehabilitationExercise program is based on aerobic exercise and supplemented by strength training following the principle of gradual improvement. The type of exercise, such as walking, jogging, cycling, and the intensity of exercise which is recommended to use a cardiotach or pedometer to detect, are both defined by the results of CPET, such as METs value. Participators must be prepared for about 5-10 minutes to warm up and recover before and after exercise. 30-50 minutes a day, 5 days a week, with a total exercise time of not less than 150 minutes per week. It can be carried out in different stages according to the physical condition. After 1-3 months, the exercise prescription will be re-adjusted according to the results of reexamination. All patients will undergo Cardiopulmonary Exercise Test, SF-36, echocardiography and laboratory examination prior to initiation of the trial, and which will be checked again after 3 months, and 6 months. | Behavioural | exercise intervention group |
Primary outcome
Peak oxygen consumption (VO2)change
Time frame: Baseline, 3, 6 months
Difference in the interval changes from baseline to 3 months and 6 months in peak VO2 comparing Experimental group with control.
11 secondary outcomes
Ventilatory efficiency (VE/VCO2 slope) change
Time frame: Baseline, 3, 6 months
oxygen consumption (VO2) at anaerobic threshold
Time frame: Baseline, 3, 6 months
Oxygen uptake related to work rate（ΔVO2/ΔWR）change
Time frame: Baseline, 3, 6 months
Peak /AT Oxygen Pulse (O2-Pulse)change
Time frame: Baseline, 3, 6 months
Peak metabolic equivalent (MET) change
Time frame: Baseline, 3, 6 months
Heart rate variability
Time frame: Baseline, 3, 6 months
Body mass index（BMI）change
Time frame: Baseline, 3, 6 months
LVEF change
Time frame: Baseline, 3, 6 months
NT-proBNP(pg/ml)
Time frame: Baseline, 3, 6 months
The MOS item short form health survey(SF-36)
Time frame: Baseline, 3, 6 months
The occurrence and composite of major adverse cardiac events (MACE)
Time frame: 3, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- 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.
Qin Shao, M.D,Ph.D study chair
RenJi Hospital
Jun Ma, M.D,Ph.D study director
RenJi 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-based cardiac rehabilitation in people with Acute Myocardial Infarction, run by RenJi Hospital 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 3 inclusion and 11 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 5 Feb 2021. 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 Qin Shao, M.D,Ph.D (86-21-68385225, shaoqindr@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak oxygen consumption (VO2)change (time frame: Baseline, 3, 6 months). 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 5 Feb 2021.