Contrast Enhanced Resonance Angiography (MRA) in the Diagnosis of Atherosclerotic Disease: A Pilot Technical Development Study
Collecte de données
Maladies Occlusives des Artères+2
+ Maladies Cardiovasculaires
+ Maladies vasculaires
Résumé
Date de début de l'étude : 1 mars 1999
Date à laquelle le premier participant a commencé l'étude.Contrast Enhanced Magnetic Resonance Angiography (MRA) is a developing technology that permits the non-invasive evaluation of arterial and venous structures without the need for x-ray based catheter angiography. While dramatic progress has been made in the last few years, there are still substantial limitations in the accuracy of MRA in judging stenoses and detecting small accessory vessels. The purpose of this study is to recruit patients with suspected or documented atherosclerotic disease for evaluation with state-of-the-art MRA using new surface coils, new pulse sequence designs, novel contrast administration strategies, and advanced image processing algorithms. This work represents a collaboration between NIH, USUHS and General Electric Medical Systems and is supported by a Cooperative Research Agreement (CRADA). The goal of this pilot study is to improve MRA to the point that it can reliably replace diagnostic x-ray catheter angiography in the evaluation of patients with atherosclerotic disease.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.100 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
INCLUSION CRITERIA: Patients must live in the Metropolitan Washington Area. Patients must have suspected atherosclerotic disease based on clinical findings or documented by angiography or doppler ultrasound performed within 3 months of the MRA. Patients must be willing to participate in the protocol. Patients must be referred by a physician who is caring for the patient and to whom the results will be provided. Patients must be clinically stable and be judged by their physician able to come to the Clinical Center to participate in the study. Patients must have serum Creatinine value less than 3.0 mg/dl. EXCLUSION CRITERIA: Any contraindication for MRI including: (a) pacemaker or other implanted electronic device; (b) cochlear implants; (c) metal in the eye; (d) embedded shrapnel fragments; (e) cerebral aneurysm clips; or (f) medical infusion pumps. Allergy to Gadolinium based contrast media. Unsatisfactory performance status as judged by the referring physician such that the patient could not tolerate an MRI scan. Examples of medical conditions that would not be accepted would include angina, dyspnea at rest, congestive heart failure, severe claudication (less than 1 flight of steps). Intercurrent illness that requires treatment that would be jeopardized by the MRA scan. Subjects requiring sedation for MRI studies. Pregnant female. Patients with severe back-pain who will be unable to tolerate supine positioning within the MRI scanner for the duration of the examination.
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Warren G. Magnuson Clinical Center (CC)
Bethesda, United StatesOuvrir Warren G. Magnuson Clinical Center (CC) dans Google Maps