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

NCT ID: NCT01683903

Last Updated: 2012-09-12

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2014-08-31

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.

Conditions

Heart Failure

Keywords

heart failure; cardiac rehabilitation; myocardial infarction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Non coronary patients (NC)

Patient with myocardial infarction with non-coronary (NC) etiology

No interventions assigned to this group

Coronary patients (C)

Patients with myocardial infarction due to coronary disease

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Sud Francilien

OTHER

Sponsor Role: lead

Responsible Party

KOUKOUI Francois

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centre Hospitalien Sud Francilien

Corbeil, , France

Site Status: RECRUITING

Countries

France

Facility Contacts

Francois Koukoui, MD

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 18799522 (View on PubMed)

Koukoui F, Desmoulin F, Lairy G, Bleinc D, Boursiquot L, Galinier M, Smih F, Rouet P. Benefits of cardiac rehabilitation in heart failure patients according to etiology: INCARD French study. Medicine (Baltimore). 2015 Feb;94(7):e544. doi: 10.1097/MD.0000000000000544.

Reference Type: DERIVED

PMID: 25700319 (View on PubMed)

Other Identifiers

INCARD

Identifier Type: -

Identifier Source: org_study_id