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Clinical Trials/NCT05320848
NCT05320848
Enrolling By Invitation
Not Applicable

Value of Cardiac Rehabilitation on the Treatment of Cardiovascular Disease

Shenzhen People's Hospital1 site in 1 country100 target enrollmentFebruary 1, 2021

Overview

Phase
Not Applicable
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.

Registry
clinicaltrials.gov
Start Date
February 1, 2021
End Date
February 1, 2025
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Shenzhen People's Hospital
Responsible Party
Sponsor

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

Study Sites (1)

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