Value of Cardiac Rehabilitation on the Treatment of Cardiovascular Disease
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cardiac Rehabilitation
- Sponsor
- Shenzhen People's Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- first occurrence of major adverse cardiovascular events (MACE)
- Status
- Enrolling by Invitation
- Last Updated
- 4 years ago
Overview
Brief Summary
Cardiac rehabilitation is a valuable treatment for patients with a broad spectrum of cardiac disease. Current guidelines support its use in patients after acute coronary syndrome, coronary artery bypass grafting, coronary stent placement, valve surgery, and stable chronic systolic heart failure. Its use in these conditions is supported by a robust body of research demonstrating improved clinical outcomes. Despite this evidence, cardiac rehabilitation referral and attendance remains low and interventions to increase its use need to be developed.
Detailed Description
The trial was conducted in Shenzhen in China. This study will recruit 100 patients with cardiovascular disease with a median and minimum follow-up of 24 and 6 months. Patients will be individually randomized to receive either a cardiac rehabilitation program (n = 50) or enhanced standard care involving educational advice (n = 50). The co-primary outcomes are: 1) first occurrence of major adverse cardiovascular events (MACE) (composite of all-cause mortality, myocardial infarction, stroke, or emergency cardiovascular hospitalization); and 2) self-rated health on the Quality of Life-5 Dimensions-5 Level visual analogue scale.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Cardiovascular disease
Exclusion Criteria
- •Incalculable TFC
- •Coronary artery spasm or ectasia
- •LV ejection fraction \< 52% in males or \< 54% in females
- •Abnormal heart structure (congenital heart disease, cardiomyopathies, or valvular dysfunction)
- •Pericardial disease (pericardial effusion or constrictive pericarditis)
- •Previous history of myocardial infarction
- •Uncontrolled hypertension (systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 105 mmHg)
- •Hyperthyroidism
- •Hypothyroidism
- •Malignancy
Outcomes
Primary Outcomes
first occurrence of major adverse cardiovascular events (MACE)
Time Frame: 3 years
first occurrence of major adverse cardiovascular events (MACE) (composite of all-cause mortality, myocardial infarction, stroke, or emergency cardiovascular hospitalization)
maximum oxygen uptake
Time Frame: 3 years
maximum oxygen uptake