Coronary Artery DiseaseASSISTNCT03102346
efficAcy and Safety of Home-baSed Cardiac rehabIlitation in ChineSe Revascularized patienTs
A study testing home-based cardiac rehabilitation in people with Coronary Artery Disease, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Home-based CR (HBCR) was reported to improve the clinical outcomes of coronary artery disease (CAD) patients. There is no data published to investigate whether HBCR is also effective for Chinese CAD patients who have been revascularized. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- home-based cardiac rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 9 Nov 2017to Dec 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all of them
- age range from 30 to 80.
- coronary artery disease,revascularized with stent deployment.
- New York Heart Association (NYHA) classification Class I-III.
- Good cognitive level.
- Ability to perform aerobic exercise.
- Understand be able to use a mobile smart phone by himself or with help of family members.
- Signature of informed consent. The informed consent will be valid for the duration of the trial or until the subject withdraws.
Who cannot join
- Presence of malignant arrhythmias such as ventricular fibrillation outside the acute phase of Acute myocardial infarction (AMI) (> 24 h after AMI), ventricular tachycardia, Atrioventricular block of 2nd degree and 3rd degree, Atrial fibrilation (FA) in patients with Wolf Parkinson White, fibrillation or paroxysmal atrial flutter with response ventricular quickly and hemodynamic deterioration, premature ventricular contractions increases during exertion, paroxysmal supraventricular tachycardia uncontrolled.
- Hypotensive response to exercise.
- acute myocardial infarction within 2 weeks
- Poorly controlled hypertension baseline,hyperglycemia,respiratory failure.
- severe pulmonary hypertension
- acute phase of heart failure
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- Pathology of musculoskeletal, neurological or breathing that impair the ability of prolonged ambulation.
- Pregnant women.
- Subjects unable to give informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First People's Hospital of Yunnan Province
Kunming, Yunnan, 650032
YUNMEI ZHANG, MD, 8613888182536, zym888198@sina.com
KE ZHUANG, MD, 8613888901747, zhuangke@trails1.cn
About this study
Official title: A Perspective Randomized Controlled Clinical Trial to Investigate the Effect of Home-based Cardiac Rehabilitation Monitored by Mobile Phone Interaction on Exercise Capacity and One-year Clinical Outcome in Chinese Revascularized Patients
Home-based CR (HBCR) was reported to improve the clinical outcomes of coronary artery disease (CAD) patients. There is no data published to investigate whether HBCR is also effective for Chinese CAD patients who have been revascularized.
This trial was designed to investigate the safety and efficacy of CR program at home for Chinese patients who underwent PCI (Percutaneous Coronary Intervention) procedure. This is a multicenter, randomized, controlled and observational study.
Read the detailed description
Numerous studies have revealed that cardiac rehabilitation (CR) after myocardial Cardiac rehabilitation (CR) after revascularization results in better clinical outcomes, and have been strongly recommended for patients with coronary artery disease. In China, as compared to the exponential increase of PCI (Percutaneous Coronary Intervention) volume, only a very small amount of hospitals are able to develop CR programs. There is no large-scale study to explore the feasible CR pattern either. Home-based CR might be more favorable and practical for so many Chinese revascularized coronary artery disease (CAD) patients due to its feasibility and flexibility as well as low medical cost.
This trial was designed to investigate the safety and efficacy of CR program at home for Chinese patients who underwent PCI procedure. This is a multicenter, randomized, controlled and observational study. The efficacy and safety of Home-based CR (HBCR) in revascularized patients will be evaluated through observation of its clinical characteristics and safety indicators. The study will involve 14 sites nationwide, with an expected sample size of 2,000 followed up for 12 months. The primary endpoints is the incidence of composite major adverse cardiac and cerebrovascular events (MACCE,death from any cause, nonfatal myocardial infarction, revascularization, stroke).Secondary endpoints are defined as decrease of hospitalization due to refractory angina pectoris，the improvements of cardiorespiratory fitness,life quality,as well as angina pectoris.
The subjects will be randomized into 2 different groups, HBCR group and control group. After comprehensive evaluation, the orders from CR staff will be given. Besides the routine health education in both groups, the subjects in HBCR group will be further introduced the instructions of exercise training. The effect of HBCR on cardiorespiratory fitness, improvement of angina, cardiac function, quality of life, levels of anxiety and depression, as well as risk factor profile will also be evaluated. The investigators also aim to explore the factors which influence the adherence of subjects to our HBCR program.
- Conditions
- Coronary Artery Disease
- Being tested
- home-based cardiac rehabilitation
- Keywords
- cardiorespiratory fitness, coronary artery disease, cardiac rehabilitation, remote control, major adverse cardiac and cerebrovascular events
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home-based cardiac rehabilitationOther
Also called exercise training at home
The exercise training includes aerobic exercise (fast walking or cycling ,30-40 minutes per day,5-6 times a week), stretching exercise (15 minutes every time, 5-6 times a week), and resistance and balance training (each of 15 minutes every time, twice to 3 times a week).
| Study group | Role | What they receive |
|---|---|---|
| Home-based Cardiac Rehabilitation group | Experimental | remote instructed exercise training at home Receives: Other: home-based cardiac rehabilitation |
| routine group | No intervention | no instructed exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACCE(death, nonfatal myocardial infarction, revascularization, stroke)
defined as the incidence of composite MACCE.
Measured: during 12 months
Secondary outcomes (4)
improvement of hospitalization due to refractory angina pectoris
improvement of hospitalization due to refractory angina pectoris which need to be treated in hospital
Measured: during 12 months
improvement of cardiorespiratory fitness
peak oxygen uptake adjusted by body weight measured by cardiopulmonary exercise test
Measured: during 12 months
improvement of life quality
measured by medical outcomes study 36-item short form health survey
Measured: during 12 months
improvement of angina pectoris
measured by Seattle Angina Questionnaire.
Measured: during 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start9 Nov 2017
- Primary completionAug 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yun Dai Chen, Chinese PLA General Hospital
- Investigators
- Yundai Chen, MD,PHD, Principal investigator, Director of department of Cardiology, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102346
- Sponsor's protocol ID
- S2016-142-01
- Acronym
- ASSIST
- Status last verified
- Apr 2019
- First submitted
- 25 Mar 2017
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
DeBusk RF, Miller NH, Parker KM, Bandura A, Kraemer HC, Cher DJ, West JA, Fowler MB, Greenwald G. Care management for low-risk patients with heart failure: a randomized, controlled trial. Ann Intern Med. 2004 Oct 19;141(8):606-13. doi: 10.7326/0003-4819-141-8-200410190-00008.
PubMed 15492340Haskell WL, Alderman EL, Fair JM, Maron DJ, Mackey SF, Superko HR, Williams PT, Johnstone IM, Champagne MA, Krauss RM, et al. Effects of intensive multiple risk factor reduction on coronary atherosclerosis and clinical cardiac events in men and women with coronary artery disease. The Stanford Coronary Risk Intervention Project (SCRIP). Circulation. 1994 Mar;89(3):975-90. doi: 10.1161/01.cir.89.3.975.
PubMed 8124838Froelicher V, Jensen D, Genter F, Sullivan M, McKirnan MD, Witztum K, Scharf J, Strong ML, Ashburn W. A randomized trial of exercise training in patients with coronary heart disease. JAMA. 1984 Sep 14;252(10):1291-7.
PubMed 6381770Newton M, Mutrie N, McArthur JD. The effects of exercise in a coronary rehabilitation programme. Scott Med J. 1991 Apr;36(2):38-41. doi: 10.1177/003693309103600203.
PubMed 1853191Conraads VM, Van Craenenbroeck EM, Pattyn N, Cornelissen VA, Beckers PJ, Coeckelberghs E, De Maeyer C, Denollet J, Frederix G, Goetschalckx K, Hoymans VY, Possemiers N, Schepers D, Shivalkar B, Vanhees L. Rationale and design of a randomized trial on the effectiveness of aerobic interval training in patients with coronary artery disease: the SAINTEX-CAD study. Int J Cardiol. 2013 Oct 9;168(4):3532-6. doi: 10.1016/j.ijcard.2013.05.007. Epub 2013 May 24.
PubMed 23711446Soga Y, Yokoi H, Amemiya K, Iwabuchi M, Nobuyoshi M. Safety and efficacy of exercise training after coronary stenting in patients with stable coronary artery disease. Circ J. 2011;75(10):2379-86. doi: 10.1253/circj.cj-11-0470. Epub 2011 Jul 28.
PubMed 21799272Perez-Terzic CM. Exercise in cardiovascular diseases. PM R. 2012 Nov;4(11):867-73. doi: 10.1016/j.pmrj.2012.10.003.
PubMed 23174552
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Perspective Randomized Controlled Clinical Trial to Investigate the Effect of Home-based Cardiac Rehabilitation Monitored by Mobile Phone Interaction on Exercise Capacity and One-year Clinical Outcome in Chinese Revascularized Patients
- ClinicalTrials.gov ID
- NCT03102346
- Acronym / sponsor ID
- ASSIST / S2016-142-01
- Conditions
- Coronary Artery Disease
- Keywords
- cardiorespiratory fitness, coronary artery disease, cardiac rehabilitation, remote control, major adverse cardiac and cerebrovascular events
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 9 Nov 2017 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 5 Apr 2017 (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.
Home-based CR (HBCR) was reported to improve the clinical outcomes of coronary artery disease (CAD) patients. There is no data published to investigate whether HBCR is also effective for Chinese CAD patients who have been revascularized.
This trial was designed to investigate the safety and efficacy of CR program at home for Chinese patients who underwent PCI (Percutaneous Coronary Intervention) procedure. This is a multicenter, randomized, controlled and observational study.
Detailed description
Numerous studies have revealed that cardiac rehabilitation (CR) after myocardial Cardiac rehabilitation (CR) after revascularization results in better clinical outcomes, and have been strongly recommended for patients with coronary artery disease. In China, as compared to the exponential increase of PCI (Percutaneous Coronary Intervention) volume, only a very small amount of hospitals are able to develop CR programs. There is no large-scale study to explore the feasible CR pattern either. Home-based CR might be more favorable and practical for so many Chinese revascularized coronary artery disease (CAD) patients due to its feasibility and flexibility as well as low medical cost.
This trial was designed to investigate the safety and efficacy of CR program at home for Chinese patients who underwent PCI procedure. This is a multicenter, randomized, controlled and observational study. The efficacy and safety of Home-based CR (HBCR) in revascularized patients will be evaluated through observation of its clinical characteristics and safety indicators. The study will involve 14 sites nationwide, with an expected sample size of 2,000 followed up for 12 months. The primary endpoints is the incidence of composite major adverse cardiac and cerebrovascular events (MACCE,death from any cause, nonfatal myocardial infarction, revascularization, stroke).Secondary endpoints are defined as decrease of hospitalization due to refractory angina pectoris，the improvements of cardiorespiratory fitness,life quality,as well as angina pectoris.
The subjects will be randomized into 2 different groups, HBCR group and control group. After comprehensive evaluation, the orders from CR staff will be given. Besides the routine health education in both groups, the subjects in HBCR group will be further introduced the instructions of exercise training. The effect of HBCR on cardiorespiratory fitness, improvement of angina, cardiac function, quality of life, levels of anxiety and depression, as well as risk factor profile will also be evaluated. The investigators also aim to explore the factors which influence the adherence of subjects to our HBCR program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home-based Cardiac Rehabilitation group | Experimental | Other: home-based cardiac rehabilitationremote instructed exercise training at home |
| routine group | No intervention | –no instructed exercise training |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- all of them
- age range from 30 to 80.
- coronary artery disease,revascularized with stent deployment.
- New York Heart Association (NYHA) classification Class I-III.
- Good cognitive level.
Key exclusion criteria (9 listed)
- Presence of malignant arrhythmias such as ventricular fibrillation outside the acute phase of Acute myocardial infarction (AMI) (> 24 h after AMI), ventricular tachycardia, Atrioventricular block of 2nd degree and 3rd degree, Atrial fibrilation (FA) in patients with Wolf Parkinson White, fibrillation or paroxysmal atrial flutter with response ventricular quickly and hemodynamic deterioration, premature ventricular contractions increases during exertion, paroxysmal supraventricular tachycardia uncontrolled.
- Hypotensive response to exercise.
- acute myocardial infarction within 2 weeks
- Poorly controlled hypertension baseline,hyperglycemia,respiratory failure.
- severe pulmonary hypertension
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 |
|---|---|---|
| home-based cardiac rehabilitationAlso: exercise training at homeThe exercise training includes aerobic exercise (fast walking or cycling ,30-40 minutes per day,5-6 times a week), stretching exercise (15 minutes every time, 5-6 times a week), and resistance and balance training (each of 15 minutes every time, twice to 3 times a week). | Other | Home-based Cardiac Rehabilitation group |
Primary outcome
MACCE(death, nonfatal myocardial infarction, revascularization, stroke)
Time frame: during 12 months
defined as the incidence of composite MACCE.
4 secondary outcomes
improvement of hospitalization due to refractory angina pectoris
Time frame: during 12 months
improvement of cardiorespiratory fitness
Time frame: during 12 months
improvement of life quality
Time frame: during 12 months
improvement of angina pectoris
Time frame: during 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Background: PubMed 15492340DeBusk RF, Miller NH, Parker KM, Bandura A, Kraemer HC, Cher DJ, West JA, Fowler MB, Greenwald G. Care management for low-risk patients with heart failure: a randomized, controlled trial. Ann Intern Med. 2004 Oct 19;141(8):606-13. doi: 10.7326/0003-4819-141-8-200410190-00008.
- Background: PubMed 8124838Haskell WL, Alderman EL, Fair JM, Maron DJ, Mackey SF, Superko HR, Williams PT, Johnstone IM, Champagne MA, Krauss RM, et al. Effects of intensive multiple risk factor reduction on coronary atherosclerosis and clinical cardiac events in men and women with coronary artery disease. The Stanford Coronary Risk Intervention Project (SCRIP). Circulation. 1994 Mar;89(3):975-90. doi: 10.1161/01.cir.89.3.975.
- Background: PubMed 6381770Froelicher V, Jensen D, Genter F, Sullivan M, McKirnan MD, Witztum K, Scharf J, Strong ML, Ashburn W. A randomized trial of exercise training in patients with coronary heart disease. JAMA. 1984 Sep 14;252(10):1291-7.
- Background: PubMed 1853191Newton M, Mutrie N, McArthur JD. The effects of exercise in a coronary rehabilitation programme. Scott Med J. 1991 Apr;36(2):38-41. doi: 10.1177/003693309103600203.
- Background: PubMed 23711446Conraads VM, Van Craenenbroeck EM, Pattyn N, Cornelissen VA, Beckers PJ, Coeckelberghs E, De Maeyer C, Denollet J, Frederix G, Goetschalckx K, Hoymans VY, Possemiers N, Schepers D, Shivalkar B, Vanhees L. Rationale and design of a randomized trial on the effectiveness of aerobic interval training in patients with coronary artery disease: the SAINTEX-CAD study. Int J Cardiol. 2013 Oct 9;168(4):3532-6. doi: 10.1016/j.ijcard.2013.05.007. Epub 2013 May 24.
- Background: PubMed 21799272Soga Y, Yokoi H, Amemiya K, Iwabuchi M, Nobuyoshi M. Safety and efficacy of exercise training after coronary stenting in patients with stable coronary artery disease. Circ J. 2011;75(10):2379-86. doi: 10.1253/circj.cj-11-0470. Epub 2011 Jul 28.
- Background: PubMed 23174552Perez-Terzic CM. Exercise in cardiovascular diseases. PM R. 2012 Nov;4(11):867-73. doi: 10.1016/j.pmrj.2012.10.003.
- 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.
Yundai Chen, MD,PHD principal investigator
Director of department of Cardiology, Chinese PLA General 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 home-based cardiac rehabilitation in people with Coronary Artery Disease, run by Chinese PLA General 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 8 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 16 Apr 2019. 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 Jing Ma, MD,PHD (86-10-66935316, crystalma_301@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACCE(death, nonfatal myocardial infarction, revascularization, stroke) (time frame: during 12 months). 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 NCT03102346, which also lists 7 linked publications.
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 16 Apr 2019.