- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01683903
Comparison of Cardiac Rehabilitation Benefits Between Coronary and Non-coronary Patients Through a 24 Months Follow-up After Myocardial Infarction: the "INCARD" Study (INCARD)
Comparison of Cardiac Rehabilitation Benefits Between Coronary and Non-coronary Patients Through a 24 Months Follow-up : the "INCARD" Study
Visão geral do estudo
Status
Condições
Descrição detalhada
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.
Tipo de estudo
Inscrição (Antecipado)
Contactos e Locais
Locais de estudo
-
-
-
Corbeil, França, 91100
- Recrutamento
- Centre Hospitalien Sud Francilien
-
Contato:
- Francois Koukoui, MD
- Número de telefone: 00(33)161698086
- E-mail: francois.koukoui@ch-sud-francilien.fr
-
Investigador principal:
- Francois Koukoui, MD
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
---|
Non coronary patients (NC)
Patient with myocardial infarction with non-coronary (NC) etiology
|
Coronary patients (C)
Patients with myocardial infarction due to coronary disease
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Change in VO2max every 6 months over the 24 months
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- 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. Erratum In: Eur Heart J. 2010 Apr;12(4):416. Dosage error in article text. Eur Heart J. 2010 Mar;31(5):624. Dosage error in article text.
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- INCARD
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Insuficiência cardíaca
-
Region SkaneInscrevendo-se por conviteInsuficiência Cardíaca Classe II da New York Heart Association (NYHA) | Insuficiência Cardíaca Classe III da New York Heart Association (NYHA)Suécia
-
Medical University of BialystokInstitute of Cardiology, Warsaw, Poland; Medical University of Lodz; Poznan University... e outros colaboradoresAinda não está recrutandoInsuficiência Cardíaca Sistólica | Insuficiência Cardíaca com Fração de Ejeção Reduzida | Insuficiência Cardíaca Classe IV da New York Heart Association | Insuficiência Cardíaca Classe III da New York Heart AssociationPolônia
-
University of WashingtonAmerican Heart AssociationConcluídoInsuficiência Cardíaca, Congestiva | Alteração Mitocondrial | Insuficiência Cardíaca Classe IV da New York Heart AssociationEstados Unidos