GRAMSMulticenter, Open-label Study to Evaluate the Safety and Efficacy (by Blinded Reading) of Gadobutrol-enhanced Magnetic Resonance Angiography (MRA) After a Single Injection of 0.1 mmol/kg of Gadobutrol in Subjects With Known or Suspected Renal Artery Disease
Gadobutrol (Gadovist, BAY86-4875)
Enfermedades Oclusivas Arteriales+5
+ Enfermedades Urogenitales
+ Enfermedades Cardiovasculares
Estudio Diagnóstico
Resumen
Fecha de inicio: 1 de mayo de 2011
Fecha en la que se inscribió al primer participante.Subjects referred for a routine CTA (computed tomography angiography) or MRA (magnetic resonance angiography) will be invited to participate in the study and subjects will be involved in the study for between 2 and 12 days. Two to three visits to the study doctor will be required. This study will compare the diagnostic results of Gadobutrol enhanced MRA images with MRA images taken without contrast agent using images from a CTA as the standard of reference, which may have been performed up to 60 days prior to enrolment. If a CTA has not been performed in this prior time period, a CTA is required for the study. MRA and CTA images will be collected for an independent review (blinded read).
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 317 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio Diagnóstico
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: * Male or female subjects, aged ≥ 18 years * Known or suspected renal artery disease based on any of the following: * Referred for evaluation of the renal arteries for clinically significant stenosis * Follow-up for a metallic stent in a renal artery * Prior imaging study (CTA) showing ≥ 50% renal artery stenosis (within 60 days prior to consent) * Willingness to undergo the routine Contrast Enhanced Magnetic Resonance Angiography (CE MRA) examinations with gadobutrol. * Willingness and ability to follow directions and complete all study procedures specified in the protocol. * Females of childbearing potential only: Negative pregnancy test on the day of the MRA prior to administration of study drug. * Written informed consent (IC), including information about the provisions of the Health Insurance Portability and Accountability Act (HIPAA) as applicable. Exclusion Criteria: * Pregnant or nursing (including pumping for storage and feeding) * Received any other investigational product or participation in any other clinical trial within 30 days before enrollment into this study * Previous enrolment into this study or into any other Bayer sponsored study using gadobutrol * Contraindication to the MRA examinations (e.g. inability to hold breath; severe arrhythmias; very low cardiac output, severe claustrophobia, defibrillators or other metallic devices not approved for MRI) * Contraindication to the use of Gd-containing contrast agents (including subjects with suspicion for or known to have Nefrogenic Systemic Fibrosis (NSF) * History of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents * Received any contrast agent within 72 hours before the study MRA, or scheduled receipt of any contrast agent within 24 hours after the study MRA (Note: This applies also to a CTA potentially scheduled during the course of the study.) * Estimated glomerular filtration rate (eGFR) value \< 30 ml/min/1.73 m2 derived from a serum creatinine result within 2 weeks before the gadobutrol injection. Any subject on hemodialysis or peritoneal dialysis is excluded from participation. Use the value obtained prior to and closest to the time of the MRA, if there are multiple creatinine values. (Do not use the core lab value if not available prior to the MRA.) * Acute renal insufficiency of any intensity, either due to hepato-renal syndrome or occurring in the peri-operative liver transplantation period * Severe cardiovascular disease (e.g. acute myocardial infarction \[\< 14 days\], unstable angina, congestive heart failure New York Heart Association class IV) or known long QT syndrome
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios