<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03303781</url>
  </required_header>
  <id_info>
    <org_study_id>BeSingCardioRehab01</org_study_id>
    <nct_id>NCT03303781</nct_id>
  </id_info>
  <brief_title>BeSingCardioRehab: CR in Belgium Versus Singapore</brief_title>
  <official_title>BeSingCardioRehab: An Intercontinental Retrospective Cohort Study Comparing Cardiac Rehabilitation in Belgium and Singapore</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hasselt University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jessa Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hasselt University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Cardiac rehabilitation is indicated for ischemic heart disease patients; the&#xD;
      program content of which is well described in both European and American guidelines. In&#xD;
      contrast, literature on cardiac rehabilitation program content and efficacy in the Asian&#xD;
      population is sparse.&#xD;
&#xD;
      Methods: BeSingCardioRehab will be an intercontinental, retrospective cohort study conducted&#xD;
      in two cardiac rehabilitation referral centers in Belgium and Singapore. The first aim is to&#xD;
      compare the impact of phase II center-based cardiac rehabilitation on Major Adverse Cardiac&#xD;
      Events for ischemic heart disease patients between Europe (i.e. Belgian) and Asia (i.e.&#xD;
      Singaporean) in the long-term. The second objective is to compare the efficacy of phase II&#xD;
      cardiac rehabilitation on short-term morbidity (assessed with the validated SMART Risk Score)&#xD;
      between index European and Asian ischemic heart disease patients. The level of compliance of&#xD;
      the Belgian and Singaporean cardiac rehabilitation programs to European guidelines standards&#xD;
      will also be evaluated.&#xD;
&#xD;
      Hypotheses BeSingCardiorehab will be one of the first studies assessing cardiac&#xD;
      rehabilitation in Asia. Based on the BeSingCardioRehab study results, phase II center-based&#xD;
      cardiac rehabilitation programs, can/will be adapted in order to improve program content and&#xD;
      outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BeSingCardioRehab is an intercontinental, multi-center, retrospective cohort study conducted&#xD;
      in two cardiac rehabilitation referral centers (Heart Center Hasselt in Belgium and National&#xD;
      Heart Center Singapore in Singapore).&#xD;
&#xD;
      Patients will be divided in four groups (1:1:1:1) based on i. whether or not they received&#xD;
      phase II cardiac rehabilitation and ii. whether they are from Belgium or Singapore.&#xD;
&#xD;
      The first objective of BeSingCardioRehab is to compare the impact of phase II center-based&#xD;
      cardiac rehabilitation on Major Adverse Cardiac Events for ischemic heart disease patients&#xD;
      between Europe (i.e. Belgian) and Asia (i.e. Singaporean) in the long-term. The second&#xD;
      objective is to compare the efficacy of phase II cardiac rehabilitation on short-term&#xD;
      morbidity (assessed with the validated SMART Risk Score) between index European and Asian&#xD;
      ischemic heart disease patients. The level of compliance of the Belgian and Singaporean&#xD;
      cardiac rehabilitation programs to European guidelines standards will also be evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2018</start_date>
  <completion_date type="Actual">January 1, 2021</completion_date>
  <primary_completion_date type="Actual">September 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>MACE</measure>
    <time_frame>From date of index hospitalisation to a common stopping date (1 September 2017).</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>SMART Risk Score</measure>
    <time_frame>week 12</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">2792</enrollment>
  <condition>Ischemic Heart Disease</condition>
  <arm_group>
    <arm_group_label>BE + CR</arm_group_label>
    <description>Belgian ischemic heart disease patients with cardiac rehabilitation program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BE-CR</arm_group_label>
    <description>Belgian ischemic heart disease patients without cardiac rehabilitation program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Si + CR</arm_group_label>
    <description>Singapore (Asian) ischemic heart disease patients with cardiac rehabilitation program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SI -CR</arm_group_label>
    <description>Singapore (Asian) ischemic heart disease patients without cardiac rehabilitation program</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cardiac Rehabilitation</intervention_name>
    <description>phase II center-based cardiac rehabilitation</description>
    <arm_group_label>BE + CR</arm_group_label>
    <arm_group_label>Si + CR</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        ligible study participants include patients suffering from stable ischemic heart disease,&#xD;
        enrolled in phase II center-based cardiac rehabilitation. Stable ischemic heart disease is&#xD;
        defined as i. patients in the revascularised, stabilized and asymptomatic phase following&#xD;
        an acute coronary syndrome (ACS) (unstable angina, non ST-elevation ACS or ST-elevation&#xD;
        ACS) or ii. patients initially presenting with stable angina who are revascularised or&#xD;
        asymptomatic under optimal medical treatment (not amenable for revascularization) [2-4].&#xD;
        Phase II cardiac rehabilitation is defined as the secondary prevention center-based&#xD;
        intervention performed following the index cardiovascular disease event with the aim of&#xD;
        clinical stabilization, risk stratification, and promotion of a long-term healthy status.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        i. patients in the revascularised, stabilized and asymptomatic phase following an acute&#xD;
        coronary syndrome (ACS) (unstable angina, non ST-elevation ACS or ST-elevation ACS)&#xD;
&#xD;
        ii. patients initially presenting with stable angina who are revascularised or asymptomatic&#xD;
        under optimal medical treatment (not amenable for revascularization).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        i. end-stage chronic kidney disease (stage V, GFR &lt; 15 ml/min/1.73 m2 and/or dialysis) ii.&#xD;
        severe chronic obstructive pulmonary disease (COPD) (GOLD stage III-IV, Tiffeneau index &lt;&#xD;
        0.70 and FEV1 &lt; 49% of normal) iii. terminal cancer with a prognosis of &lt; 1 year.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul Dendale</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jessa Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jessa Hospital</name>
      <address>
        <city>Hasselt</city>
        <zip>3500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Heart Center Singapore</name>
      <address>
        <city>Singapore</city>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Singapore</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <last_update_submitted>February 8, 2021</last_update_submitted>
  <last_update_submitted_qc>February 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hasselt University</investigator_affiliation>
    <investigator_full_name>prof. dr. Paul Dendale</investigator_full_name>
    <investigator_title>prof. dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03303781
org study id: BeSingCardioRehab01
nct id: NCT03303781
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Ecologic or Community
time perspective: Retrospective
measure: MACE
time frame: From date of index hospitalisation to a common stopping date (1 September 2017).
description: 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.
measure: SMART Risk Score
time frame: week 12
description: 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.
arm group label: BE + CR
description: Belgian ischemic heart disease patients with cardiac rehabilitation program
arm group label: BE-CR
description: Belgian ischemic heart disease patients without cardiac rehabilitation program
arm group label: Si + CR
description: Singapore (Asian) ischemic heart disease patients with cardiac rehabilitation program
arm group label: SI -CR
description: Singapore (Asian) ischemic heart disease patients without cardiac rehabilitation program
intervention type: Other
intervention name: Cardiac Rehabilitation
description: phase II center-based cardiac rehabilitation
arm group label: BE + CR
arm group label: Si + CR
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Paul Dendale
role: Principal Investigator
affiliation: Jessa Hospital
facility: 
facility: 
country: Belgium
country: Singapore
responsible party type: Principal Investigator
investigator affiliation: Hasselt University
investigator full name: prof. dr. Paul Dendale
investigator title: prof. dr.
mesh term: Heart Diseases
mesh term: Myocardial Ischemia
mesh term: Coronary Artery Disease
sharing ipd: Undecided