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

September 10, 2012 updated by: KOUKOUI Francois, Centre Hospitalier Sud Francilien

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

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

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Corbeil, France, 91100
        • Recruiting
        • Centre Hospitalien Sud Francilien
        • Contact:
        • Principal Investigator:
          • Francois Koukoui, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Chronic heart failure patients

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Non coronary patients (NC)
Patient with myocardial infarction with non-coronary (NC) etiology
Coronary patients (C)
Patients with myocardial infarction due to coronary disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
every 6 months over the 24 months of outpatient follow-up
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 %
every 6 months over the 24 months of outpatient follow-up
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)
every 6 months over the 24 months of outpatient follow-up
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.
every 6 months over the 24 months of outpatient follow-up
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)
every 6 months over the 24 months of outpatient follow-up
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)
every 6 months over the 24 months of outpatient follow-up
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)
every 6 months over the 24 months of outpatient follow-up
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)
every 6 months over the 24 months of outpatient follow-up
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)
every 6 months over the 24 months of outpatient follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Sud Francilien

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Anticipated)

August 1, 2014

Study Completion (Anticipated)

August 1, 2014

Study Registration Dates

First Submitted

August 10, 2012

First Submitted That Met QC Criteria

September 10, 2012

First Posted (Estimate)

September 12, 2012

Study Record Updates

Last Update Posted (Estimate)

September 12, 2012

Last Update Submitted That Met QC Criteria

September 10, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCARD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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