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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Centre Hospitalier Sud Francilien.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
KOUKOUI Francois, Centre Hospitalier Sud Francilien
ClinicalTrials.gov Identifier:
NCT01683903
First received: August 10, 2012
Last updated: September 10, 2012
Last verified: September 2012
  Purpose

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


Condition
Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Cardiac Rehabilitation Benefits Between Coronary and Non-coronary Patients Through a 24 Months Follow-up : the "INCARD" Study

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Sud Francilien:

Primary Outcome Measures:
  • Change in VO2max every 6 months over the 24 months [ Time Frame: every 6 months over the 24 months of outpatient follow-up ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    creatine clearance (ml/min)


Estimated Enrollment: 150
Study Start Date: August 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Chronic heart failure patients

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01683903

Locations
France
Centre Hospitalien Sud Francilien Recruiting
Corbeil, France, 91100
Contact: Francois Koukoui, MD    00(33)161698086    francois.koukoui@ch-sud-francilien.fr   
Principal Investigator: Francois Koukoui, MD         
Sponsors and Collaborators
Centre Hospitalier Sud Francilien
  More Information

Publications:
Responsible Party: KOUKOUI Francois, MD, Centre Hospitalier Sud Francilien
ClinicalTrials.gov Identifier: NCT01683903     History of Changes
Other Study ID Numbers: INCARD
Study First Received: August 10, 2012
Last Updated: September 10, 2012
Health Authority: France: French Data Protection Authority

Keywords provided by Centre Hospitalier Sud Francilien:
heart failure
cardiac rehabilitation
myocardial infarction

Additional relevant MeSH terms:
Heart Failure
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014