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BeSingCardioRehab: CR in Belgium Versus Singapore

H

Hasselt University

Status

Completed

Conditions

Ischemic Heart Disease

Treatments

Other: Cardiac Rehabilitation

Study type

Observational

Funder types

Other

Identifiers

NCT03303781
BeSingCardioRehab01

Details and patient eligibility

About

Background: Cardiac rehabilitation is indicated for ischemic heart disease patients; the program content of which is well described in both European and American guidelines. In contrast, literature on cardiac rehabilitation program content and efficacy in the Asian population is sparse.

Methods: BeSingCardioRehab will be an intercontinental, retrospective cohort study conducted in two cardiac rehabilitation referral centers in Belgium and Singapore. The first aim is to compare the impact of phase II center-based cardiac rehabilitation on Major Adverse Cardiac Events for ischemic heart disease patients between Europe (i.e. Belgian) and Asia (i.e. Singaporean) in the long-term. The second objective is to compare the efficacy of phase II cardiac rehabilitation on short-term morbidity (assessed with the validated SMART Risk Score) between index European and Asian ischemic heart disease patients. The level of compliance of the Belgian and Singaporean cardiac rehabilitation programs to European guidelines standards will also be evaluated.

Hypotheses BeSingCardiorehab will be one of the first studies assessing cardiac rehabilitation in Asia. Based on the BeSingCardioRehab study results, phase II center-based cardiac rehabilitation programs, can/will be adapted in order to improve program content and outcomes.

Full description

BeSingCardioRehab is an intercontinental, multi-center, retrospective cohort study conducted in two cardiac rehabilitation referral centers (Heart Center Hasselt in Belgium and National Heart Center Singapore in Singapore).

Patients will be divided in four groups (1:1:1:1) based on i. whether or not they received phase II cardiac rehabilitation and ii. whether they are from Belgium or Singapore.

The first objective of BeSingCardioRehab is to compare the impact of phase II center-based cardiac rehabilitation on Major Adverse Cardiac Events for ischemic heart disease patients between Europe (i.e. Belgian) and Asia (i.e. Singaporean) in the long-term. The second objective is to compare the efficacy of phase II cardiac rehabilitation on short-term morbidity (assessed with the validated SMART Risk Score) between index European and Asian ischemic heart disease patients. The level of compliance of the Belgian and Singaporean cardiac rehabilitation programs to European guidelines standards will also be evaluated.

Enrollment

2,792 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

i. patients in the revascularised, stabilized and asymptomatic phase following an acute coronary syndrome (ACS) (unstable angina, non ST-elevation ACS or ST-elevation ACS)

ii. patients initially presenting with stable angina who are revascularised or asymptomatic under optimal medical treatment (not amenable for revascularization).

Exclusion criteria

i. end-stage chronic kidney disease (stage V, GFR < 15 ml/min/1.73 m2 and/or dialysis) ii. severe chronic obstructive pulmonary disease (COPD) (GOLD stage III-IV, Tiffeneau index < 0.70 and FEV1 < 49% of normal) iii. terminal cancer with a prognosis of < 1 year.

Trial design

2,792 participants in 4 patient groups

BE + CR
Description:
Belgian ischemic heart disease patients with cardiac rehabilitation program
Treatment:
Other: Cardiac Rehabilitation
BE-CR
Description:
Belgian ischemic heart disease patients without cardiac rehabilitation program
Si + CR
Description:
Singapore (Asian) ischemic heart disease patients with cardiac rehabilitation program
Treatment:
Other: Cardiac Rehabilitation
SI -CR
Description:
Singapore (Asian) ischemic heart disease patients without cardiac rehabilitation program

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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