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Comparison of Cardiac Rehabilitation Benefits Between Coronary and Non-coronary Patients Through a 24 Months Follow-up After Myocardial Infarction: the "INCARD" Study (INCARD)

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ClinicalTrials.gov Identifier: NCT01683903
Recruitment Status : Unknown
Verified September 2012 by KOUKOUI Francois, Centre Hospitalier Sud Francilien.
Recruitment status was:  Recruiting
First Posted : September 12, 2012
Last Update Posted : September 12, 2012
Sponsor:
Information provided by (Responsible Party):
KOUKOUI Francois, Centre Hospitalier Sud Francilien

Tracking Information
First Submitted Date August 10, 2012
First Posted Date September 12, 2012
Last Update Posted Date September 12, 2012
Study Start Date August 2012
Estimated Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 10, 2012)
  • Change in VO2max every 6 months over the 24 months [ Time Frame: every 6 months over the 24 months of outpatient follow-up ]
    VO2max (L)
  • 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 ]
    Left ventricular ejection fraction (ultrasound method and/or isotopic) in %
  • 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 ]
    6-min walk test (m)
  • 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 ]
    Minnesota index of quality of life.
  • Change on heart rate every 6 months over the 24 months [ Time Frame: every 6 months over the 24 months of outpatient follow-up ]
    Heart rate (bpm)
  • 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 ]
    systolic blood pressure (mmHg)
  • 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 ]
    diastolic blood pressure (mmHg)
  • 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 ]
    Measurement of weight and height, calculation of body mass index (kg/m2)
  • Change on creatine clearance every 6 months over the 24 months [ Time Frame: every 6 months over the 24 months of outpatient follow-up ]
    creatine clearance (ml/min)
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Comparison of Cardiac Rehabilitation Benefits Between Coronary and Non-coronary Patients Through a 24 Months Follow-up After Myocardial Infarction: the "INCARD" Study
Official Title Comparison of Cardiac Rehabilitation Benefits Between Coronary and Non-coronary Patients Through a 24 Months Follow-up : the "INCARD" Study
Brief Summary 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
Detailed Description

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Chronic heart failure patients
Condition Heart Failure
Intervention Not Provided
Study Groups/Cohorts
  • Non coronary patients (NC)
    Patient with myocardial infarction with non-coronary (NC) etiology
  • Coronary patients (C)
    Patients with myocardial infarction due to coronary disease
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: September 10, 2012)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2014
Estimated Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age over 18 years old,
  • Signed informed consent,
  • Patients with left ventricular ejection fraction below 40 %,
  • Stable for over 3 weeks,
  • Known etiology,
  • Able to do the performance test on treadmil or bicycle in order to have rehabilitation.
  • No clinical avoidance reasons.
  • Patient with health care registration.
  • Agreement from the general practictioner and from the cardiologist that follows the patient.

Exclusion Criteria:

  • Age below 18 years old,
  • Unstable heart failure,
  • Unable to do a performance test as indicated above,
  • Patients not able to understand clinical counseling.
  • Patient under tutella.
  • Pregnancy.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01683903
Other Study ID Numbers INCARD
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party KOUKOUI Francois, Centre Hospitalier Sud Francilien
Study Sponsor Centre Hospitalier Sud Francilien
Collaborators Not Provided
Investigators Not Provided
PRS Account Centre Hospitalier Sud Francilien
Verification Date September 2012