Clinical trial NCT03303781: BeSingCardioRehab: CR in Belgium Versus Singapore
Official title: BeSingCardioRehab: An Intercontinental Retrospective Cohort Study Comparing Cardiac Rehabilitation in Belgium and Singapore
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Heart Disease
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Jessa Hospital
First posted: 2017-10-06
Enrollment: 2792
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: MACE
timeFrame: From date of index hospitalisation to a common stopping date (1 September 2017).
Secondary outcomes:
measure: SMART Risk Score
timeFrame: week 12
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Hospital
city: Singapore
country: Singapore
facility: National Heart Center Singapore
Study officials:
affiliation: Jessa Hospital
name: Paul Dendale
role: PRINCIPAL_INVESTIGATOR
References: