BeSingCardioRehab: CR in Belgium Versus Singapore

Completed

• Conditions: Ischemic Heart Disease
• Interventions: Other: Cardiac Rehabilitation

• Registration Number: NCT03303781
• Lead Sponsor: Hasselt University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-09-28
• Study First Submitted QC: 2017-10-02
• Study First Posted: 2017-10-06
• Study Start: 2018-04-01
• Primary Completion: 2020-09-01
• Study Completion: 2021-01-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-08
• Last Update Posted: 2021-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2792

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Si + CR	Cardiac Rehabilitation	Singapore (Asian) ischemic heart disease patients with cardiac rehabilitation program
BE + CR	Cardiac Rehabilitation	Belgian ischemic heart disease patients with cardiac rehabilitation program

Primary Outcome Measures

Name	Time	Method
MACE	From date of index hospitalisation to a common stopping date (1 September 2017).	The primary endpoint is MACE, which is a composite of death from cardiovascular causes, non-fatal myocardial infarction, or non-fatal stroke \[13\] in the long-term.

Secondary Outcome Measures

Name	Time	Method
SMART Risk Score	week 12	The secondary endpoint is the short-term cardiovascular risk, assessed by the validated SMART Risk Score. Short-term is defined as 12 weeks after the index ischemic heart disease event.

Trial Locations

Locations (2)

National Heart Center Singapore; 🇸🇬 Singapore, Singapore

Jessa Hospital; 🇧🇪 Hasselt, Belgium