- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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 di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
-
Singapore, Singapore, 169609
- National Heart Centre Singapore
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
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.
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
---|---|
Control
Healthy Volunteers will undergo the following studying procedures: Cardiovascular Magnetic Resonance Imagine (MRI) Cardiopulmonary exercise testing (CPET) Echocardiography |
Per misurare le dimensioni della camera cardiaca, la funzione cardiaca, le dimensioni dei vasi sanguigni e la funzione dei vasi sanguigni.
Queste misurazioni ci aiuteranno a capire il tipo e la gravità dell'insufficienza cardiaca.
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 |
Per misurare le dimensioni della camera cardiaca, la funzione cardiaca, le dimensioni dei vasi sanguigni e la funzione dei vasi sanguigni.
Queste misurazioni ci aiuteranno a capire il tipo e la gravità dell'insufficienza cardiaca.
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Prima occorrenza di evento cardiovascolare
Lasso di tempo: 1 anno
|
1 anno
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Ru San Tan, MBBS, National Heart Centre Singapore
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2012/856/C
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Cardiopatia congenita
-
Region SkaneIscrizione su invitoInsufficienza cardiaca Classe II della New York Heart Association (NYHA). | Insufficienza cardiaca Classe III della New York Heart Association (NYHA).Svezia
-
Medical University of BialystokInstitute of Cardiology, Warsaw, Poland; Medical University of Lodz; Poznan University... e altri collaboratoriNon ancora reclutamentoInsufficienza cardiaca, sistolica | Insufficienza cardiaca con frazione di eiezione ridotta | Scompenso cardiaco Classe IV della New York Heart Association | Scompenso cardiaco Classe III della New York Heart AssociationPolonia
-
University of WashingtonAmerican Heart AssociationCompletatoInsufficienza cardiaca, congestizia | Alterazione mitocondriale | Scompenso cardiaco Classe IV della New York Heart AssociationStati Uniti