BeSingCardioRehab: CR in Belgium Versus Singapore

NCT ID: NCT03303781

Last Updated: 2021-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2792 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-01

Study Completion Date

2021-01-01

Brief Summary

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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

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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.

Conditions

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Ischemic Heart Disease

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

RETROSPECTIVE

Study Groups

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BE + CR

Belgian ischemic heart disease patients with cardiac rehabilitation program

Cardiac Rehabilitation

Intervention Type OTHER

phase II center-based cardiac rehabilitation

BE-CR

Belgian ischemic heart disease patients without cardiac rehabilitation program

No interventions assigned to this group

Si + CR

Singapore (Asian) ischemic heart disease patients with cardiac rehabilitation program

Cardiac Rehabilitation

Intervention Type OTHER

phase II center-based cardiac rehabilitation

SI -CR

Singapore (Asian) ischemic heart disease patients without cardiac rehabilitation program

No interventions assigned to this group

Interventions

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Cardiac Rehabilitation

phase II center-based cardiac rehabilitation

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jessa Hospital

OTHER

Sponsor Role collaborator

Hasselt University

OTHER

Sponsor Role lead

Responsible Party

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prof. dr. Paul Dendale

prof. dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paul Dendale

Role: PRINCIPAL_INVESTIGATOR

Jessa Hospital

Locations

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Jessa Hospital

Hasselt, , Belgium

Site Status

National Heart Center Singapore

Singapore, , Singapore

Site Status

Countries

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Belgium Singapore

Other Identifiers

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BeSingCardioRehab01

Identifier Type: -

Identifier Source: org_study_id

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