<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/NCT01683903</url>
  </required_header>
  <id_info>
    <org_study_id>INCARD</org_study_id>
    <nct_id>NCT01683903</nct_id>
  </id_info>
  <brief_title>Comparison of Cardiac Rehabilitation Benefits Between Coronary and Non-coronary Patients Through a 24 Months Follow-up After Myocardial Infarction: the &quot;INCARD&quot; Study</brief_title>
  <acronym>INCARD</acronym>
  <official_title>Comparison of Cardiac Rehabilitation Benefits Between Coronary and Non-coronary Patients Through a 24 Months Follow-up : the &quot;INCARD&quot; Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Sud Francilien</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Sud Francilien</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Treatment of chronic heart failure requires multidisciplinary approaches with a recognized&#xD;
      role for cardiac rehabilitation. Rehabilitation helps to improve patient's functional,&#xD;
      decrease morbidity and mortality, decrease rehospitalization rate, thereby reducing costs of&#xD;
      this disease. After recovery from the acute phase of cardiac infarction, patients admitted to&#xD;
      the rehabilitation center will follow the usual rehabilitation program during the&#xD;
      hospitalization period. This step precludes outpatient follow-up period in our day hospital,&#xD;
      in accordance with their physicians and cardiologists who manage the monitoring. The study&#xD;
      INCARD (Insuffisance Cardiaque en Readaptation Durable) will be developed to evaluate the&#xD;
      benefits of a sustainable rehabilitation heart failure on patients treated optimally and&#xD;
      educated during a follow-up period of 24 months. The main objective of the study will be to&#xD;
      compare the benefits of rehabilitation between coronary (C) and non-coronary (NC) patients&#xD;
      for each evaluation time point, periodically recorded&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We will undertake a prospective follow-up study of 150 rehabilitated patients with heart&#xD;
      failure (75 C; 75 NC). The main objective will be to compare the benefits of rehabilitation&#xD;
      between coronary and non-coronary patients based on functional improvement i.e. improvements&#xD;
      of VO2max, LVEF (ultrasound method and/or isotopic), 6-min walk test, Minnesota index of&#xD;
      quality of life. In addition, clinical outcomes (HR, SBP, DBP, BMI) and paraclinical data&#xD;
      (creatinine clearance) will be measured as patients' standard clinical follow-up .&#xD;
&#xD;
      Clinical data of the patients admitted to the cardiac rehabilitation, including heart failure&#xD;
      patients (LVEF &lt;40), will be recorded after collection of their signed informed consent&#xD;
      agreement. Patients will be addressed from heart failure intensive care units for coronary&#xD;
      (USIC) or acute cardiac services to the rehabilitation department. Patients will be admitted&#xD;
      in the rehabilitation department when there are clinically stable (at least three weeks after&#xD;
      the acute episode). Etiology of the heart failure will be assessed and patients stratified as&#xD;
      C or NC patients.&#xD;
&#xD;
      Expected Results We will estimate the mean duration of inpatient rehabilitation (H period).&#xD;
      Then, we will follow patients' cardiac evaluation parameters recorded from an outpatient&#xD;
      follow-up, first 3 months after inclusion and then every 6 months over the 24 months of&#xD;
      outpatient follow-up.&#xD;
&#xD;
      These data will allow for comparison of the benefits of rehabilitation between coronary (C)&#xD;
      and non-coronary (NC) patients for each evaluation time point and will give information on&#xD;
      the clinical improvement of each group of patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">August 2014</completion_date>
  <primary_completion_date type="Anticipated">August 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in VO2max every 6 months over the 24 months</measure>
    <time_frame>every 6 months over the 24 months of outpatient follow-up</time_frame>
    <description>VO2max (L)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Left ventricular ejection fraction every 6 months over the 24 months of outpatient follow-up</measure>
    <time_frame>every 6 months over the 24 months of outpatient follow-up</time_frame>
    <description>Left ventricular ejection fraction (ultrasound method and/or isotopic) in %</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change on 6-min walk test every 6 months over the 24 months</measure>
    <time_frame>every 6 months over the 24 months of outpatient follow-up</time_frame>
    <description>6-min walk test (m)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change on Minnesota index of quality of life every 6 months over the 24 months</measure>
    <time_frame>every 6 months over the 24 months of outpatient follow-up</time_frame>
    <description>Minnesota index of quality of life.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change on heart rate every 6 months over the 24 months</measure>
    <time_frame>every 6 months over the 24 months of outpatient follow-up</time_frame>
    <description>Heart rate (bpm)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change on systolic blood pressure every 6 months over the 24 months</measure>
    <time_frame>every 6 months over the 24 months of outpatient follow-up</time_frame>
    <description>systolic blood pressure (mmHg)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change on diastolic blood pressure every 6 months over the 24 months</measure>
    <time_frame>every 6 months over the 24 months of outpatient follow-up</time_frame>
    <description>diastolic blood pressure (mmHg)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change on body mass index every 6 months over the 24 months</measure>
    <time_frame>every 6 months over the 24 months of outpatient follow-up</time_frame>
    <description>Measurement of weight and height, calculation of body mass index (kg/m2)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change on creatine clearance every 6 months over the 24 months</measure>
    <time_frame>every 6 months over the 24 months of outpatient follow-up</time_frame>
    <description>creatine clearance (ml/min)</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Non coronary patients (NC)</arm_group_label>
    <description>Patient with myocardial infarction with non-coronary (NC) etiology</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Coronary patients (C)</arm_group_label>
    <description>Patients with myocardial infarction due to coronary disease</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Chronic heart failure patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age over 18 years old,&#xD;
&#xD;
          -  Signed informed consent,&#xD;
&#xD;
          -  Patients with left ventricular ejection fraction below 40 %,&#xD;
&#xD;
          -  Stable for over 3 weeks,&#xD;
&#xD;
          -  Known etiology,&#xD;
&#xD;
          -  Able to do the performance test on treadmil or bicycle in order to have&#xD;
             rehabilitation.&#xD;
&#xD;
          -  No clinical avoidance reasons.&#xD;
&#xD;
          -  Patient with health care registration.&#xD;
&#xD;
          -  Agreement from the general practictioner and from the cardiologist that follows the&#xD;
             patient.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age below 18 years old,&#xD;
&#xD;
          -  Unstable heart failure,&#xD;
&#xD;
          -  Unable to do a performance test as indicated above,&#xD;
&#xD;
          -  Patients not able to understand clinical counseling.&#xD;
&#xD;
          -  Patient under tutella.&#xD;
&#xD;
          -  Pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centre Hospitalien Sud Francilien</name>
      <address>
        <city>Corbeil</city>
        <zip>91100</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Francois Koukoui, MD</last_name>
      <phone>00(33)161698086</phone>
      <email>francois.koukoui@ch-sud-francilien.fr</email>
    </contact>
    <investigator>
      <last_name>Francois Koukoui, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Dickstein K, Cohen-Solal A, Filippatos G, McMurray JJ, Ponikowski P, Poole-Wilson PA, Stromberg A, van Veldhuisen DJ, Atar D, Hoes AW, Keren A, Mebazaa A, Nieminen M, Priori SG, Swedberg K; ESC Committee for Practice Guidelines (CPG). ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2008: the Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2008 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association of the ESC (HFA) and endorsed by the European Society of Intensive Care Medicine (ESICM). Eur Heart J. 2008 Oct;29(19):2388-442. doi: 10.1093/eurheartj/ehn309. Epub 2008 Sep 17. No abstract available. Erratum In: Eur Heart J. 2010 Apr;12(4):416. Dosage error in article text. Eur Heart J. 2010 Mar;31(5):624. Dosage error in article text.</citation>
    <PMID>18799522</PMID>
  </reference>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>August 10, 2012</study_first_submitted>
  <study_first_submitted_qc>September 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2012</study_first_posted>
  <last_update_submitted>September 10, 2012</last_update_submitted>
  <last_update_submitted_qc>September 10, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 12, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre Hospitalier Sud Francilien</investigator_affiliation>
    <investigator_full_name>KOUKOUI Francois</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>heart failure</keyword>
  <keyword>cardiac rehabilitation</keyword>
  <keyword>myocardial infarction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Myocardial Infarction</mesh_term>
  </condition_browse>
  <!-- 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/NCT01683903
org study id: INCARD
nct id: NCT01683903
lead sponsor: 
has dmc: No
Treatment of chronic heart failure requires multidisciplinary approaches with a recognized
      role for cardiac rehabilitation. Rehabilitation helps to improve patient's functional,
      decrease morbidity and mortality, decrease rehospitalization rate, thereby reducing costs of
      this disease. After recovery from the acute phase of cardiac infarction, patients admitted to
      the rehabilitation center will follow the usual rehabilitation program during the
      hospitalization period. This step precludes outpatient follow-up period in our day hospital,
      in accordance with their physicians and cardiologists who manage the monitoring. The study
      INCARD (Insuffisance Cardiaque en Readaptation Durable) will be developed to evaluate the
      benefits of a sustainable rehabilitation heart failure on patients treated optimally and
      educated during a follow-up period of 24 months. The main objective of the study will be to
      compare the benefits of rehabilitation between coronary (C) and non-coronary (NC) patients
      for each evaluation time point, periodically recorded
We will undertake a prospective follow-up study of 150 rehabilitated patients with heart
      failure (75 C; 75 NC). The main objective will be to compare the benefits of rehabilitation
      between coronary and non-coronary patients based on functional improvement i.e. improvements
      of VO2max, LVEF (ultrasound method and/or isotopic), 6-min walk test, Minnesota index of
      quality of life. In addition, clinical outcomes (HR, SBP, DBP, BMI) and paraclinical data
      (creatinine clearance) will be measured as patients' standard clinical follow-up .

      Clinical data of the patients admitted to the cardiac rehabilitation, including heart failure
      patients (LVEF <40), will be recorded after collection of their signed informed consent
      agreement. Patients will be addressed from heart failure intensive care units for coronary
      (USIC) or acute cardiac services to the rehabilitation department. Patients will be admitted
      in the rehabilitation department when there are clinically stable (at least three weeks after
      the acute episode). Etiology of the heart failure will be assessed and patients stratified as
      C or NC patients.

      Expected Results We will estimate the mean duration of inpatient rehabilitation (H period).
      Then, we will follow patients' cardiac evaluation parameters recorded from an outpatient
      follow-up, first 3 months after inclusion and then every 6 months over the 24 months of
      outpatient follow-up.

      These data will allow for comparison of the benefits of rehabilitation between coronary (C)
      and non-coronary (NC) patients for each evaluation time point and will give information on
      the clinical improvement of each group of patients.
observational model: Cohort
time perspective: Prospective
measure: Change in VO2max every 6 months over the 24 months
time frame: every 6 months over the 24 months of outpatient follow-up
description: VO2max (L)
measure: Change in Left ventricular ejection fraction every 6 months over the 24 months of outpatient follow-up
time frame: every 6 months over the 24 months of outpatient follow-up
description: Left ventricular ejection fraction (ultrasound method and/or isotopic) in %
measure: Change on 6-min walk test every 6 months over the 24 months
time frame: every 6 months over the 24 months of outpatient follow-up
description: 6-min walk test (m)
measure: Change on Minnesota index of quality of life every 6 months over the 24 months
time frame: every 6 months over the 24 months of outpatient follow-up
description: Minnesota index of quality of life.
measure: Change on heart rate every 6 months over the 24 months
time frame: every 6 months over the 24 months of outpatient follow-up
description: Heart rate (bpm)
measure: Change on systolic blood pressure every 6 months over the 24 months
time frame: every 6 months over the 24 months of outpatient follow-up
description: systolic blood pressure (mmHg)
measure: Change on diastolic blood pressure every 6 months over the 24 months
time frame: every 6 months over the 24 months of outpatient follow-up
description: diastolic blood pressure (mmHg)
measure: Change on body mass index every 6 months over the 24 months
time frame: every 6 months over the 24 months of outpatient follow-up
description: Measurement of weight and height, calculation of body mass index (kg/m2)
measure: Change on creatine clearance every 6 months over the 24 months
time frame: every 6 months over the 24 months of outpatient follow-up
description: creatine clearance (ml/min)
arm group label: Non coronary patients (NC)
description: Patient with myocardial infarction with non-coronary (NC) etiology
arm group label: Coronary patients (C)
description: Patients with myocardial infarction due to coronary disease
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
country: France
citation: Dickstein K, Cohen-Solal A, Filippatos G, McMurray JJ, Ponikowski P, Poole-Wilson PA, Stromberg A, van Veldhuisen DJ, Atar D, Hoes AW, Keren A, Mebazaa A, Nieminen M, Priori SG, Swedberg K; ESC Committee for Practice Guidelines (CPG). ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2008: the Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2008 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association of the ESC (HFA) and endorsed by the European Society of Intensive Care Medicine (ESICM). Eur Heart J. 2008 Oct;29(19):2388-442. doi: 10.1093/eurheartj/ehn309. Epub 2008 Sep 17. No abstract available. Erratum In: Eur Heart J. 2010 Apr;12(4):416. Dosage error in article text. Eur Heart J. 2010 Mar;31(5):624. Dosage error in article text.
PMID: 18799522
responsible party type: Principal Investigator
investigator affiliation: Centre Hospitalier Sud Francilien
investigator full name: KOUKOUI Francois
investigator title: MD
mesh term: Heart Failure
mesh term: Myocardial Infarction