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L'essai clinique NCT04281823 (DEBAKEY-CMR) pour Maladies cardiovasculaires est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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DeBakey Cardiovascular Magnetic Resonance Study (DEBAKEY-CMR)

En recrutement
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L'étude clinique NCT04281823 (DEBAKEY-CMR) est un essai observationnel pour Maladies cardiovasculaires. Son statut actuel est : en recrutement. L'étude a débuté le 1 avril 2008 et vise à recruter 100 000 participants. Dirigé par Dipan Shah, l'essai devrait être terminé d'ici le 1 avril 2058. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 24 février 2020.
Résumé succinct
While advancements in cardiac magnetic resonance (CMR) have improved image quality, it is unclear how these improvements are connected to the clinical evaluation of individuals with cardiovascular disease. The aim of this large prospective registry revolves around 4 key principles: 1) utilize CMR to gain additional pathophysiologic insights into cardiovascular disease, 2) understand how CMR compares to alternative cardiovascular diagnostic modalities, 3) determine how CMR affects clinical management decisions, and 4) establish a link between CMR findings and long term prognosis in patients with known or suspected cardiovascular disease. The ultimate aim is to utilize CMR to improve patient outcomes.

CMR techniques to be studies include function, fibrosis, and flow. Focus areas include valvular heart disease, ischemic heart disease, cardiomyopathies, and vascular disease.

Description détaillée
Patient Population, Recruitment, and Consent:

Patients presenting to the Houston Methodist DeBakey CMR Laboratory will be enrolled from April 2008 to April 2038. It is expected that up to 100,000 patients may be enrolled during this period.

Subjects will be identified based on their referral to the Houston Methodist DeBakey CMR Laboratory for MRI studies during the proposed study period.

After enrollment, a registered nurse or physician will perform a thorough structured patient interview and/or review of electronic health records to document baseline medical history including cardiac risk factors, symptoms, medication usage, and prior procedure history. A small blood sample will be drawn and stored for future biomarker and/or genetic testing analysis. Annual follow up for clinical status will be performed via review of electronic health records; structured telephone interviews with the patients, relatives, and/or their health care providers; and/or the social security death index database.

Titre officiel

Houston Methodist DeBakey Cardiovascular Magnetic Resonance Study

Conditions
Maladies cardiovasculaires
Publications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:
Autres identifiants de l'essai
  • DEBAKEY-CMR
  • Pro00008766
Numéro NCT
Date de début (réel)
2008-04-01
Dernière mise à jour publiée
2020-02-24
Date de fin (estimée)
2058-04-01
Inscription (estimée)
100 000
Type d'essai
Observationnel
Statut
En recrutement
Mots clés
Cardiovascular Disease
Cardiac Magnetic Resonance
Myocardial Fibrosis
Valvular Heart Disease
Ischemic Heart Disease
Cardiomyopathy
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
Cardiovascular Magnetic Resonance
All patients who present to the Houston Methodist CMR Laboratory
Résonance magnétique cardiovasculaire
Patients will undergo various CMR techniques designed to assess cardiovascular structure and function, tissue characteristics, and flow.
Critère principal d'évaluation
Critères d'évaluationDescription de critèresPériode
Mortality
All-cause mortality, Cardiovascular mortality (acute Myocardial Infarction, sudden death, heart failure, cerebrovascular, procedural), and Non-cardiovascular mortality
Through study completion, an average of once a year, up to 20 years
Heart Failure
Congestive heart failure
Through study completion, an average of once a year, up to 20 years
Heart and/or Lung Transplantation
Through study completion, an average of once a year, up to 20 years
Left Ventricular and/or Right Ventricular Assist Device Implantation
Through study completion, an average of once a year, up to 20 years
Critère secondaire d'évaluation
Critères d'évaluationDescription de critèresPériode
Cardiac Interventions
Implantable cardioverter-defibrillator (ICD), pacemakers, cardiac resynchronization therapy, coronary revascularization, valvular intervention, shunt closure
Through study completion, an average of once a year, up to 20 years
Arrhythmic
Sustained ventricular tachycardia, ventricular fibrillation, nonfatal cardiac arrest, appropriate ICD therapy
Through study completion, an average of once a year
Acute myocardial infarction
Through study completion, an average of once a year, up to 20 years
Acute Cerebrovascular Accident
Through study completion, an average of once a year, up to 20 years
Critères d'éligibilité

Âges éligibles
Enfant, Adulte, Adulte âgé
Sexes éligibles
Tous
Accepte les volontaires en bonne santé
Oui
  • All patients presenting to the Houston Methodist CMR Laboratory with known or suspected cardiovascular disease.

  • Unable to provide informed consent
Dipan Shah logoDipan Shah
Partie responsable de l'essai
Dipan Shah, Promoteur-Investigateur, Director of Cardiovascular Imaging, The Methodist Hospital Research Institute
Contact central de l'essai
Contact: Rachel Kronman-Gross, BS, 7134416539, [email protected]
Contact: Mohamad Ghosn, PhD, 7134419837, [email protected]
1 Centres de l'essai dans 1 pays

Texas

Houston Methodist Hospital, Houston, Texas, 77030, United States
Rachel Kronman-Gross, BS, Contact, 713-441-6539, [email protected]
Mohamad Ghosn, PhD, Contact, 7134419837, [email protected]
Dipan Shah, MD, Investigateur principal
En recrutement