Acute Myocardial InfarctionNCT03528382
The Impact of Early Cardiac Rehabilitation of AMI Patients on the Incidence of Post-infarction HF
A study testing Cardiac rehabilitation quality improvement system in people with Acute Myocardial Infarction, run by Yu Bo at 1 site in China.
Trial summary
Background: Acute myocardial infarction (AMI) is the second cause of death worldwide. After AMI, the heart failure (HF) is a main cause of patient rehospitalization and death. Despite the total ischemic time of AMI is decreasing in general at present, the incidence of HF after AMI remains high. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Cardiac rehabilitation quality improvement system
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,103 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2018to 29 Sep 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged ≥18 and ≤80 years old with a diagnosis of AMI (include ST segment elevated myocardial infarction and non-ST segment elevated myocardial infarction)
Who cannot join
- Pregnancy or lactation or with family planning during the trial;
- A history of heart failure;
- Severe liver dysfunction (The Alanine aminotransferase /aspartate aminotransferase level is over 3 times the upper normal limit);
- End-stage renal disease or creatinine plasma levels > 2.0mg/Dl;
- Tumor;
- AMI is caused by surgery, trauma, gastrointestinal bleeding or other complications caused by percutaneous coronary intervention;
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- AMI occurred in patients who have been hospitalized for other reasons;
- Heart allograft transplantation;
- Participating in other clinical trials (except other subjects of this project) and have not reach the main end of the study.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150086
About this study
Official title: The Impact of Early Cardiac Rehabilitation Quality Improvement System on the Incidence of Post-infarction HF: an Interventional Study
Background: Acute myocardial infarction (AMI) is the second cause of death worldwide. After AMI, the heart failure (HF) is a main cause of patient rehospitalization and death. Despite the total ischemic time of AMI is decreasing in general at present, the incidence of HF after AMI remains high. The incidence of HF in Switzerland and the United States are 25% and 14-16%, respectively, and the epidemiological statistic of AMI in the past 10 years was lacking in China, but the rate has been exceeded 22% by conservative estimation. Early cardiac rehabilitation quality improvement system has been shown to reduce incidence of post-infarction HF and improve cardiovascular function. However, early cardiac rehabilitation has low proportion and poor quality, which lacks of standard.
Objective: The purposes of this quality improvement study are to evaluate a pointed, two-phase intervention system to improve the proportion and quality of cardiac rehabilitation; to standardize the early cardiac rehabilitation procedure to improve the prognosis among patients with post-infarction HF.
Read more
Methods: Including the period I of cardiac rehabilitation, pre-discharge (baseline) assessment and the period II of cardiac rehabilitation.
Statistical analysis: Data analyses are performed using the software package SAS version 9.2 and all tests are 2-sided with P<0.05 denoting statistical significance. Quantitative data changes between groups which are compared with using the paired Student's t test and Wilcoxon rank sum test according to the data distribution, and categorical data is analyzed by chi-square test and ranked data is analyzed by Wilcoxon rank sum test. The investigator compare the incidence of heart failure in early rehabilitation patients between two phases according to the chi-square test of the rate of two groups, to explore the role of early cardiac rehabilitation after AMI in reducing the incidence of HF after AMI.
Read the detailed description
Study design: After admission, and following clinical and diagnostic evaluation (12-lead electrocardiogram, Doppler echocardiography, symptom-limited cardiopulmonary exercise test and other related laboratory tests), all patients are discharged in low risk group (ejection fraction≥50% with AMI single-vessel lesion, emergency vascular recanalization without complication) and intermediate/high risk group (EF<50%, AMI partial blood transport reconstruction/multi-branch lesion, combined or uncombined with cardiogenic shock or heart failure). Researchers will assess inclusion and exclusion criteria, and patients who met the inclusion criteria need provide informed written consent in duplicate. All patients are enrolled in one I period rehabilitation during hospitalization and II period cardiac rehabilitation after discharge according to the different group. After 1 month, 2 months and 6 months, all patients undergo a telephone or outpatient follow-up assessment including training, smoking, drug usage and nutrient assessment. And after 3 months and 12 months, all patients undergo an outpatient follow-up assessment by 6-minute walking test and/or cardiopulmonary exercise test and three psychological scales (SF-12, GAD-7 and PHQ-9), besides the above.
The period I of cardiac rehabilitation: Patients who provide informed consents should assess indications and contraindications at first. The indications are: 1) no new emerging/repeated chest pain in 8 hours; 2) no further increase in the level of cardiac markers or cardiac enzymes (creatine kinase and troponin); 3) no obvious sign of decompensation of heart failure (the resting breath is difficult, combined with moist rale); 4) no new malignant arrhythmias or new electrocardiogram ischemic changes in the last 8 hours. The contraindications are: 1) hemodynamic instability or resting angina pectoris; 2) uncontrollable arrhythmia; 3) unable to rehabilitation due to disability or disease sequelae.
The period I of cardiac rehabilitation for low risk group is divided into five phases and each phase has three parts. The three parts are daily life (from complete rest in bed, low fat liquid diet to partly provided for themselves, low fat and semi-liquid diet to basically provided for themselves, low fat diet), rehabilitation exercise training (from passive joint exercises in bed to stand by bed and walk) and publicity and education (including introduction about cardiovascular intensive care unit, rehabilitation procedure, smoking cessation, risk factors of coronary heart disease, etc.). The period I of cardiac rehabilitation for intermediate/high risk group is divided into seven phases and each phase has three parts as well as the low risk group, but each part is more cautious than low-risk group.
Pre-discharge (baseline) assessment: One day before discharge, researchers should complete the assessment about patients who completed I period cardiac rehabilitation and fill in the cardiac rehabilitation quality feedback form. The assessments are as follows: 1) medical history assessment: recording patient medical history (coronary heart disease, hypertension, cerebrovascular disease, and/or peripheral vascular disease, hyperlipidemia, diabetes, congestive heart failure and chronic obstructive pulmonary disease, etc.); 2) physical examination: recording the heart rate, blood pressure and respiration of patients; checking whether there are engorgements of the neck veins, lung rale, cardiac souffle, arrhythmias and dropsy, etc; 3) accessory examination: recording the latest electrocardiogram and echocardiographic results); 4) nutrition assessment: assessing whether the patient is on high-fat diet or (and) high-salt diet and obese, setting a target weight based on BMI; 5) smoking assessment: assessing smoking status and let patients fill out the Fagerstrom test for nicotine dependence (FTND); 6) psychological assessment: let patients fill out the SF-12, GAD-7 and PHQ-9; 7) motor assessment: recording the maximum exercise load, the changes of heart rate and blood pressure from resting to maximum exercise load and rehabilitation process, terminal symptoms (angina and electrocardiogram abnormality), peak oxygen uptake, anaerobic threshold and alveolar air volume/carbon dioxide slope, through cardiopulmonary exercise test; 8) drug assessment: assessing and recording the name, dosage and usage of the drug; 9) adverse event assessment: assessing whether the patient with new or recurrent heart cerebral vascular disease, death and other adverse events when hospitalization, this part should be filled in the adverse event table; 10) Matters needing attention: Informing the patient or his family of precautions during the rehabilitation procedure and marking the doctor's contact number in the informed consent form, any hospitalization, reinfarction, or death should be immediately notified to the doctor.
The period II of cardiac rehabilitation: This period should last three months after discharge from the hospital. Exercise rehabilitation is based on aerobic exercise, and combined with resistance and flexibility exercises, including warm-up period (5-10 minutes), training period (20-40 minutes) and cool-down period (at least 5 minutes). Aerobic training should begin from discharge, at least 3 times per week and resistance training should begin in at least five weeks after AMI, 1 time per week at first. In addition, researchers should provide counseling about living habit and drug taking. Psychological counseling would be given to patients who have anxiety or depression.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Cardiac rehabilitation quality improvement system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac rehabilitation quality improvement systemBehavioural
Cardiac rehabilitation quality improvement system is divided into two period. The period I of rehabilitation has three parts, including daily life, rehabilitation exercise training, publicity and education. And the period II of rehabilitation is based on aerobic exercise, as well as combined with resistance and flexibility exercises
| Study group | Role | What they receive |
|---|---|---|
| period I group | Experimental | Not described Receives: Behavioral: Cardiac rehabilitation quality improvement system |
| period II group | Experimental | Not described Receives: Behavioral: Cardiac rehabilitation quality improvement system |
| period III group | Experimental | Not described Receives: Behavioral: Cardiac rehabilitation quality improvement system |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of heart failure in 1 year follow-up
The incidence of heart failure after cardiac rehabilitate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start1 Jul 2018
- Primary completion30 Jun 2021
- Study completion29 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Participant
- Enrolment
- 3,103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yu Bo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yu Bo, Harbin Medical University
- Investigators
- Bo Yu, MD,PhD, Principal investigator, The Second Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03528382
- Sponsor's protocol ID
- 2016YFC1301105
- Status last verified
- Nov 2021
- First submitted
- 7 May 2018
- Last updated
- 8 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zheng X, Zhang M, Zheng Y, Zhang Y, Wang J, Zhang P, Yang X, Li S, Ding R, Siqin G, Hou X, Chen L, Zhang M, Sun Y, Wu J, Yu B. Quality indicators for cardiac rehabilitation after myocardial infarction in China: a consensus panel and practice test. BMJ Open. 2020 Dec 30;10(12):e039757. doi: 10.1136/bmjopen-2020-039757.
PubMed 33380480
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Early Cardiac Rehabilitation Quality Improvement System on the Incidence of Post-infarction HF: an Interventional Study
- ClinicalTrials.gov ID
- NCT03528382
- Acronym / sponsor ID
- 2016YFC1301105
- Conditions
- Acute Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,103 participants (actual)
- Lead sponsor
- Yu BoUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 29 Sep 2021 (actual)
- First posted
- 17 May 2018 (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.
Background: Acute myocardial infarction (AMI) is the second cause of death worldwide. After AMI, the heart failure (HF) is a main cause of patient rehospitalization and death. Despite the total ischemic time of AMI is decreasing in general at present, the incidence of HF after AMI remains high. The incidence of HF in Switzerland and the United States are 25% and 14-16%, respectively, and the epidemiological statistic of AMI in the past 10 years was lacking in China, but the rate has been exceeded 22% by conservative estimation. Early cardiac rehabilitation quality improvement system has been shown to reduce incidence of post-infarction HF and improve cardiovascular function. However, early cardiac rehabilitation has low proportion and poor quality, which lacks of standard.
Objective: The purposes of this quality improvement study are to evaluate a pointed, two-phase intervention system to improve the proportion and quality of cardiac rehabilitation; to standardize the early cardiac rehabilitation procedure to improve the prognosis among patients with post-infarction HF.
Methods: Including the period I of cardiac rehabilitation, pre-discharge (baseline) assessment and the period II of cardiac rehabilitation.
Statistical analysis: Data analyses are performed using the software package SAS version 9.2 and all tests are 2-sided with P<0.05 denoting statistical significance. Quantitative data changes between groups which are compared with using the paired Student's t test and Wilcoxon rank sum test according to the data distribution, and categorical data is analyzed by chi-square test and ranked data is analyzed by Wilcoxon rank sum test. The investigator compare the incidence of heart failure in early rehabilitation patients between two phases according to the chi-square test of the rate of two groups, to explore the role of early cardiac rehabilitation after AMI in reducing the incidence of HF after AMI.
Detailed description
Study design: After admission, and following clinical and diagnostic evaluation (12-lead electrocardiogram, Doppler echocardiography, symptom-limited cardiopulmonary exercise test and other related laboratory tests), all patients are discharged in low risk group (ejection fraction≥50% with AMI single-vessel lesion, emergency vascular recanalization without complication) and intermediate/high risk group (EF<50%, AMI partial blood transport reconstruction/multi-branch lesion, combined or uncombined with cardiogenic shock or heart failure). Researchers will assess inclusion and exclusion criteria, and patients who met the inclusion criteria need provide informed written consent in duplicate. All patients are enrolled in one I period rehabilitation during hospitalization and II period cardiac rehabilitation after discharge according to the different group. After 1 month, 2 months and 6 months, all patients undergo a telephone or outpatient follow-up assessment including training, smoking, drug usage and nutrient assessment. And after 3 months and 12 months, all patients undergo an outpatient follow-up assessment by 6-minute walking test and/or cardiopulmonary exercise test and three psychological scales (SF-12, GAD-7 and PHQ-9), besides the above.
The period I of cardiac rehabilitation: Patients who provide informed consents should assess indications and contraindications at first. The indications are: 1) no new emerging/repeated chest pain in 8 hours; 2) no further increase in the level of cardiac markers or cardiac enzymes (creatine kinase and troponin); 3) no obvious sign of decompensation of heart failure (the resting breath is difficult, combined with moist rale); 4) no new malignant arrhythmias or new electrocardiogram ischemic changes in the last 8 hours. The contraindications are: 1) hemodynamic instability or resting angina pectoris; 2) uncontrollable arrhythmia; 3) unable to rehabilitation due to disability or disease sequelae.
The period I of cardiac rehabilitation for low risk group is divided into five phases and each phase has three parts. The three parts are daily life (from complete rest in bed, low fat liquid diet to partly provided for themselves, low fat and semi-liquid diet to basically provided for themselves, low fat diet), rehabilitation exercise training (from passive joint exercises in bed to stand by bed and walk) and publicity and education (including introduction about cardiovascular intensive care unit, rehabilitation procedure, smoking cessation, risk factors of coronary heart disease, etc.). The period I of cardiac rehabilitation for intermediate/high risk group is divided into seven phases and each phase has three parts as well as the low risk group, but each part is more cautious than low-risk group.
Pre-discharge (baseline) assessment: One day before discharge, researchers should complete the assessment about patients who completed I period cardiac rehabilitation and fill in the cardiac rehabilitation quality feedback form. The assessments are as follows: 1) medical history assessment: recording patient medical history (coronary heart disease, hypertension, cerebrovascular disease, and/or peripheral vascular disease, hyperlipidemia, diabetes, congestive heart failure and chronic obstructive pulmonary disease, etc.); 2) physical examination: recording the heart rate, blood pressure and respiration of patients; checking whether there are engorgements of the neck veins, lung rale, cardiac souffle, arrhythmias and dropsy, etc; 3) accessory examination: recording the latest electrocardiogram and echocardiographic results); 4) nutrition assessment: assessing whether the patient is on high-fat diet or (and) high-salt diet and obese, setting a target weight based on BMI; 5) smoking assessment: assessing smoking status and let patients fill out the Fagerstrom test for nicotine dependence (FTND); 6) psychological assessment: let patients fill out the SF-12, GAD-7 and PHQ-9; 7) motor assessment: recording the maximum exercise load, the changes of heart rate and blood pressure from resting to maximum exercise load and rehabilitation process, terminal symptoms (angina and electrocardiogram abnormality), peak oxygen uptake, anaerobic threshold and alveolar air volume/carbon dioxide slope, through cardiopulmonary exercise test; 8) drug assessment: assessing and recording the name, dosage and usage of the drug; 9) adverse event assessment: assessing whether the patient with new or recurrent heart cerebral vascular disease, death and other adverse events when hospitalization, this part should be filled in the adverse event table; 10) Matters needing attention: Informing the patient or his family of precautions during the rehabilitation procedure and marking the doctor's contact number in the informed consent form, any hospitalization, reinfarction, or death should be immediately notified to the doctor.
The period II of cardiac rehabilitation: This period should last three months after discharge from the hospital. Exercise rehabilitation is based on aerobic exercise, and combined with resistance and flexibility exercises, including warm-up period (5-10 minutes), training period (20-40 minutes) and cool-down period (at least 5 minutes). Aerobic training should begin from discharge, at least 3 times per week and resistance training should begin in at least five weeks after AMI, 1 time per week at first. In addition, researchers should provide counseling about living habit and drug taking. Psychological counseling would be given to patients who have anxiety or depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| period I group | Experimental | Behavioral: Cardiac rehabilitation quality improvement system |
| period II group | Experimental | Behavioral: Cardiac rehabilitation quality improvement system |
| period III group | Experimental | Behavioral: Cardiac rehabilitation quality improvement system |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged ≥18 and ≤80 years old with a diagnosis of AMI (include ST segment elevated myocardial infarction and non-ST segment elevated myocardial infarction)
Key exclusion criteria (9 listed)
- Pregnancy or lactation or with family planning during the trial;
- A history of heart failure;
- Severe liver dysfunction (The Alanine aminotransferase /aspartate aminotransferase level is over 3 times the upper normal limit);
- End-stage renal disease or creatinine plasma levels > 2.0mg/Dl;
- Tumor;
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 |
|---|---|---|
| Cardiac rehabilitation quality improvement systemCardiac rehabilitation quality improvement system is divided into two period. The period I of rehabilitation has three parts, including daily life, rehabilitation exercise training, publicity and education. And the period II of rehabilitation is based on aerobic exercise, as well as combined with resistance and flexibility exercises | Behavioural | period I group, period II group, period III group |
Primary outcome
The incidence of heart failure in 1 year follow-up
Time frame: 1 year
The incidence of heart failure after cardiac rehabilitate
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 8 Nov 2021.
- Derived from this study: PubMed 33380480Zheng X, Zhang M, Zheng Y, Zhang Y, Wang J, Zhang P, Yang X, Li S, Ding R, Siqin G, Hou X, Chen L, Zhang M, Sun Y, Wu J, Yu B. Quality indicators for cardiac rehabilitation after myocardial infarction in China: a consensus panel and practice test. BMJ Open. 2020 Dec 30;10(12):e039757. doi: 10.1136/bmjopen-2020-039757.
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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.
Bo Yu, MD,PhD principal investigator
The Second Affiliated Hospital of Harbin Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac rehabilitation quality improvement system in people with Acute Myocardial Infarction, run by Yu Bo 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 1 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: finished, as of the sponsor's last update on 8 Nov 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?
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?
The incidence of heart failure in 1 year follow-up (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03528382, which also lists 1 linked publication.
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 8 Nov 2021.