Ignite Creation Date:
2024-05-06 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 12:21 PM
Study NCT ID:
NCT03102346
Status:
UNKNOWN
Last Update Posted:
2019-04-16
First Post:
2017-03-25
Brief Title:
efficAcy and Safety of Home-baSed Cardiac rehabIlitation in ChineSe Revascularized patienTs
Sponsor:
Chinese PLA General Hospital
Organization:
Chinese PLA General Hospital
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2019-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ASSIST
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
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 2000 followed up for 12 months The primary endpoints is the incidence of composite major adverse cardiac and cerebrovascular events MACCEdeath from any cause nonfatal myocardial infarction revascularization strokeSecondary endpoints are defined as decrease of hospitalization due to refractory angina pectoristhe improvements of cardiorespiratory fitnesslife qualityas 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
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 2000 followed up for 12 months The primary endpoints is the incidence of composite major adverse cardiac and cerebrovascular events MACCEdeath from any cause nonfatal myocardial infarction revascularization strokeSecondary endpoints are defined as decrease of hospitalization due to refractory angina pectoristhe improvements of cardiorespiratory fitnesslife qualityas 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None