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

NCT01683903 | Unknown

• 1 other identifier: INCARD
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Heart Failure

Keywords

heart failure; cardiac rehabilitation; myocardial infarction

Outcome Measures

Primary Outcomes (9)

• Change in VO2max every 6 months over the 24 months

  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

  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

  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

  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

  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

  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

  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

  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

  creatine clearance (ml/min)

  every 6 months over the 24 months of outpatient follow-up

Study Arms (2)

Non coronary patients (NC)

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

Coronary patients (C)

Patients with myocardial infarction due to coronary disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chronic heart failure patients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Sud Francilien: lead

Study Sites (1)

Centre Hospitalien Sud Francilien

Corbeil, 91100, France

RECRUITING

Related Publications (2)

• 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.

  PMID: 18799522 BACKGROUND

• 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.

  PMID: 25700319 DERIVED

MeSH Terms

Conditions

Heart Failure; Myocardial Infarction

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 10, 2012
• First Posted: September 12, 2012
• Study Start: August 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: September 12, 2012

Record last verified: 2012-09

Locations

FR (1)