Clinical trial NCT03102346: efficAcy and Safety of Home-baSed Cardiac rehabIlitation in ChineSe Revascularized patienTs
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Keywords: cardiorespiratory fitness
coronary artery disease
cardiac rehabilitation
remote control
major adverse cardiac and cerebrovascular events
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2017-04-05
Enrollment: 2000
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

all of them

1. age range from 30 to 80.
2. coronary artery disease,revascularized with stent deployment.
3. New York Heart Association (NYHA) classification Class I-III.
4. Good cognitive level.
5. Ability to perform aerobic exercise.
6. Understand be able to use a mobile smart phone by himself or with help of family members.
7. Signature of informed consent. The informed consent will be valid for the duration of the trial or until the subject withdraws.

Exclusion Criteria (Enrollment):

1. 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.
2. Hypotensive response to exercise.
3. acute myocardial infarction within 2 weeks
4. Poorly controlled hypertension baseline,hyperglycemia,respiratory failure.
5. severe pulmonary hypertension
6. acute phase of heart failure
7. Pathology of musculoskeletal, neurological or breathing that impair the ability of prolonged ambulation.
8. Pregnant women.
9. Subjects unable to give informed consent.

Primary outcomes:
measure: MACCE(death, nonfatal myocardial infarction, revascularization, stroke)
timeFrame: during 12 months
Secondary outcomes:
measure: improvement of hospitalization due to refractory angina pectoris
timeFrame: during 12 months
measure: improvement of cardiorespiratory fitness
timeFrame: during 12 months
measure: improvement of life quality
timeFrame: during 12 months
measure: improvement of angina pectoris
timeFrame: during 12 months
Other outcomes:
Locations:
city: Kunming
country: China
facility: the First People's Hospital of Yunnan Province
state: Yunnan
Study officials:
affiliation: Director of department of Cardiology, Chinese PLA General Hospital
name: Yundai Chen, MD,PHD
role: PRINCIPAL_INVESTIGATOR
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