BeSingCardioRehab: CR in Belgium Versus Singapore

NCT03303781 | Completed

• 1 other identifier: BeSingCardioRehab01
• Study Type: observational
• Target: 2,792
• Locations: 2 countries
• Sites: 2

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.

Conditions

Ischemic Heart Disease

Outcome Measures

Primary Outcomes (1)

• MACE

  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.

  From date of index hospitalisation to a common stopping date (1 September 2017).

Secondary Outcomes (1)

• SMART Risk Score

  week 12

Study Arms (4)

BE + CR

Belgian ischemic heart disease patients with cardiac rehabilitation program

Other: Cardiac Rehabilitation

BE-CR

Belgian ischemic heart disease patients without cardiac rehabilitation program

Si + CR

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

Other: Cardiac Rehabilitation

SI -CR

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

Interventions

Cardiac Rehabilitation OTHER

phase II center-based cardiac rehabilitation

BE + CR; Si + CR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

ligible study participants include patients suffering from stable ischemic heart disease, enrolled in phase II center-based cardiac rehabilitation. Stable ischemic heart disease is defined as 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) or ii. patients initially presenting with stable angina who are revascularised or asymptomatic under optimal medical treatment (not amenable for revascularization) \[2-4\]. Phase II cardiac rehabilitation is defined as the secondary prevention center-based intervention performed following the index cardiovascular disease event with the aim of clinical stabilization, risk stratification, and promotion of a long-term healthy status.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hasselt University: lead
• Jessa Hospital: collaborator

Study Sites (2)

Jessa Hospital

Hasselt, 3500, Belgium

Location

National Heart Center Singapore

Singapore, Singapore

Location

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Paul Dendale

  Jessa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr.

Study Record Dates

• First Submitted: September 28, 2017
• First Posted: October 6, 2017
• Study Start: April 1, 2018
• Primary Completion: September 1, 2020
• Study Completion: January 1, 2021
• Last Updated: February 9, 2021

Record last verified: 2021-02

Locations

BE (1); SG (1)