- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02791061
Study of RV Remodeling in Congenital Heart Disease (RVShape)
Segmentation, Structural Reconstruction and Quantification of Right Ventricular Remodeling in Congenital Heart Disease for Clinical Decision-making and Treatment Planning.
The primary aims of this study are to 1. Develop an automated method of quantitation of RV remodeling in terms of regional RV surface curvature and area strain and assess the feasibility, repeatability and accuracy in normal subjects and patients with repaired TOF, patients with PS
The secondary study aims of this study are to
1. Compare the differences of RV remodeling in repaired TOF patients, PS patients with sex and age-matched controls 2, Assess the relationship of our proposed parameters to global RV function and exercise capacity in repaired TOF patients and PS patient
Visão geral do estudo
Status
Condições
Descrição detalhada
Right ventricular (RV) function is increasingly recognized to play an important role in the clinical status and long-term outcome in patients with congenital heart disease (CHD) as well as ischemic cardiomyopathy with left ventricular (LV) dysfunction. However, quantitation of RV characteristics and function, in particular for regional RV characteristics and function, are still challenging due to its complex morphology and its thin wall with coarse trabeculations. The remarkable improvement in survival of CHD patients has led to a continuously growing number of grown-up CHD. In addition, some defects (e.g., Ebstein's anomaly) may be diagnosed for the first time in adult. Majority of these CHD patients face a lifetime of problems including RV dilation, ventricular arrhythmias, and sudden cardiac death. Therefore, accurate depictions of the RV remodeling process facilitate disease would aid in surveillance and monitoring of therapeutic efficacy.
CHD patients, even after corrective surgery, need lifetime surveillance and yearly clinical evaluation. Currently, clinical evaluation includes ECG and pulse oximetries alongside clinical examination. Investigation of anatomy and physiology of RV are changing from invasive studies (right heart catheterization) to noninvasive imaging techniques including: echocardiography, nuclear scintigraphy, computed tomography, and cardiac magnetic resonance (CMR) imaging. In short, echocardiography is largely operator dependent and suffers from poor inter-study reproducibility. The complex geometry of the RV makes it difficult to accurately quantify its remodeling before and after intervention. Nuclear scintigraphy and computed tomography are constrained by the need for ionizing radiation as well as the poor temporal resolution of the technique. CMR has been considered the golden reference technique for RV volume and ejection fraction.
From current state-of-the-art in CMR, generation of RV volume and ejection fraction, global measures of RV remodeling, requires extensive manual contouring. Most important, there is lacking of regional RV remodeling measures.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
-
Singapore, Cingapura, 169609
- National Heart Centre Singapore
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
34 patients diagnosed will Tetralogy of Fallots or Pulmonary Stenosis will be recruited from primary care clinic, outpatient clinics and hospital ward in NHCS.
20 Healthy Volunteer control group.
Descrição
Inclusion Criteria:
- Survivors of TOF repair more than one year after repair without pulmonary stenosis (Doppler gradient more than 30mmHg) OR
- Patients with moderate or severe pulmonary stenosis (Echo Doppler gradient more than 30mmHg)
- Patients without prior Pulmonary Valve Replacement (PVR)
- Written informed Consent obtained
- Aged 13 to 80 years old
Exclusion Criteria:
- Age less than 13
Contraindication to MRI Examination
- Cardiac Pacemaker
- Brain Aneurysm OR clips
- Electronic implants OR prosthesis
- Eye metal foreign body injury
- Severe claustrophobia
- Known severe impairment, glomerular filtration rate GFR less than 30 ml/min/BSA
- Non Cardiac illness with life expectancy of less than 2 years
- Previous heart kidney liver or lung transplantation Pregnancy
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
---|---|
Control
Healthy Volunteers will undergo the following studying procedures: Cardiovascular Magnetic Resonance Imagine (MRI) Cardiopulmonary exercise testing (CPET) Echocardiography |
Para medir o tamanho da câmara cardíaca, a função cardíaca, o tamanho dos vasos sanguíneos e a função dos vasos sanguíneos.
Essas medições nos ajudarão a entender o tipo e a gravidade da insuficiência cardíaca.
MRI uses interaction of the magnetic properties of body tissues with strong magnetic fields to create images.
Cardiopulmonary exercise testing (CPET) is non-invasive simultaneous measurement of the cardiovascular and respiratory system during exercise to assess a patient's exercise capacity.
|
Congenital Disease
Patients will undergo the following studying procedures: Cardiovascular Magnetic Resonance Imagine (MRI) Cardiopulmonary exercise testing (CPET) Echocardiography |
Para medir o tamanho da câmara cardíaca, a função cardíaca, o tamanho dos vasos sanguíneos e a função dos vasos sanguíneos.
Essas medições nos ajudarão a entender o tipo e a gravidade da insuficiência cardíaca.
MRI uses interaction of the magnetic properties of body tissues with strong magnetic fields to create images.
Cardiopulmonary exercise testing (CPET) is non-invasive simultaneous measurement of the cardiovascular and respiratory system during exercise to assess a patient's exercise capacity.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
Primeira ocorrência de evento cardiovascular
Prazo: 1 ano
|
1 ano
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ru San Tan, MBBS, National Heart Centre Singapore
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 (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2012/856/C
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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 Doença Cardíaca Congênita
-
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
-
QLT Inc.ConcluídoLCA (Leber Congenital Amaurosis) | RP (Retinite Pigmentosa)Estados Unidos, Canadá, Alemanha, Holanda, Reino Unido
-
QLT Inc.ConcluídoLCA (Leber Congenital Amaurosis) | RP (Retinite Pigmentosa)Canadá, Estados Unidos, Alemanha, Holanda, Reino Unido