Clinical trial NCT01344447: Gadobutrol Enhanced MRA of the Supra-aortic Vessels
Official title: Multicenter, Open-label Study to Evaluate the Safety and Efficacy (by Blinded Reading) of Contrast-Enhanced Magnetic Resonance Angiography (MRA) After a Single Intravenous Injection of 0.1 mmol/kg Gadobutrol in Subjects With Known or Suspected Vascular Disease of the Supra-aortic Vessels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Carotid Stenosis
Keywords: Supra-aortic vascular disease
MRA
CTA
Males and females aged 18 years or older
Stroke
Transient Ischemic Attack (TIA)
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-04-29
Enrollment: 479
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* Male or female subjects, aged 18 years and older
* Any of the following:

  * Known or suspected supra-aortic arterial disease based on:

    * Prior stroke
    * Transient ischemic attack (TIA)
    * Amaurosis Fugax (transient monocular blindness)
  * Referred for evaluation of any supra-aortic vessel (for clinically significant stenosis)
  * Follow-up for a stent in a supra-aortic vessel
  * Prior imaging study (CTA or ultrasound) showing ≥ 50% stenosis of a supra-aortic vessel segment (within 60 days before consent). The proportion of subjects with positive disease (determined by the investigator, based on CTA or ultrasound) will be monitored during the study, and enrolment may be further restricted to require ≥ 70% stenosis to ensure that overall there are an adequate number of subjects with clinically significant disease for the evaluation of study endpoints.
* Willingness to undergo the routine Contrast Enhanced Magnetic Resonance Angiography \[CE MRA\] examination 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 before the administration of study drug

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 enrollment 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 Nephrogenic 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
* Suspected clinical instability or unpredictability of the clinical course during the study period (e.g. due to previous surgery)
* Scheduled or potentially expected for the period between the CTA and gadobutrol MRA:

  * Any procedure that may alter the MRA or CTA interpretation, or
  * Any interventional or surgical procedure involving the supra-aortic vessels

Primary outcomes:
measure: Percentage of Assessable Vascular Segments Using Gadobutrol-Enhanced MRA and Unenhanced MRA
timeFrame: Images were taken pre-injection and post-injection
measure: Sensitivity for Detection of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA
timeFrame: Images were taken pre-injection and post-injection
measure: Specificity for Exclusion of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA
timeFrame: Images were taken pre-injection and post-injection
measure: Minimum Gadobutrol Performance for Sensitivity: Sensitivity > 50%
timeFrame: Images were taken pre-injection and post-injection
measure: Minimum Gadobutrol Performance for Specificity: Specificity > 50%
timeFrame: Images were taken pre-injection and post-injection
Secondary outcomes:
measure: Vessel Diameter (Millimeter [mm]) at the Normal Point and the Narrowest Point in Gadobutrol-Enhanced MRA, Unenhanced MRA and CTA Images
timeFrame: Images were taken pre-injection and post-injection
measure: The Percentage of Segments With Artifacts Presence
timeFrame: Images were taken pre-injection and post-injection
measure: Types of Artifacts on a Segment Basis by Blinded Reader 1
timeFrame: Images were taken pre-injection and post-injection
measure: Types of Artifacts on a Segment Basis by Blinded Reader 2
timeFrame: Images were taken pre-injection and post-injection
measure: Types of Artifacts on a Segment Basis by Blinded Reader 3
timeFrame: Images were taken pre-injection and post-injection
measure: The Percentage of Location of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA
timeFrame: Images were taken pre-injection and post-injection
measure: Length of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA
timeFrame: Images were taken pre-injection and post-injection
measure: The Percentage of Presence of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease
timeFrame: Images were taken pre-injection and post-injection
measure: Type of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease
timeFrame: Images were taken pre-injection and post-injection
measure: Diagnostic Confidence by the Blinded Readers Using Gadobutrol-Enhanced MRA and Unenhanced MRA
timeFrame: Images were taken pre-injection and post-injection
measure: The Percentage of Participants With Additional Imaging Studies Recommended by the Blinded Readers and the Clinical Investigator After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images
timeFrame: Images were taken pre-injection and post-injection
measure: Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 1
timeFrame: Images were taken pre-injection and post-injection
measure: Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 2
timeFrame: Images were taken pre-injection and post-injection
measure: Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 3
timeFrame: Images were taken pre-injection and post-injection
measure: Types of Additional Imaging Studies Recommended by the Clinical Investigator After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images
timeFrame: Images were taken pre-injection and post-injection
Other outcomes:
Locations:
city: Tucson
country: United States
state: Arizona
city: Jacksonville
country: United States
state: Florida
city: Savannah
country: United States
state: Georgia
city: Louisville
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Jackson
country: United States
state: Mississippi
city: Bronx
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Philadelphia
country: United States
state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Memphis
country: United States
state: Tennessee
city: Seattle
country: United States
state: Washington
city: Madison
country: United States
state: Wisconsin
city: Adrogué
country: Argentina
state: Buenos Aires
city: Buenos Aires
country: Argentina
state: Ciudad Auton. De Buenos Aires
city: Buenos Aires
country: Argentina
state: Ciudad Auton. De Buenos Aires
city: New Lambton Heights
country: Australia
state: New South Wales
city: Clayton
country: Australia
state: Victoria
city: Parkville
country: Australia
state: Victoria
city: Innsbruck
country: Austria
state: Tirol
city: Wien
country: Austria
city: Shanghai
country: China
city: Shanghai
country: China
city: Brno
country: Czechia
city: Brest Cedex
country: France
city: BRON Cedex
country: France
city: Marseille
country: France
city: Paris Cedex 15
country: France
city: Paris
country: France
city: Karlsruhe
country: Germany
state: Baden-Württemberg
city: Augsburg
country: Germany
state: Bayern
city: Erlangen
country: Germany
state: Bayern
city: Münster
country: Germany
state: Nordrhein-Westfalen
city: Jena
country: Germany
state: Thüringen
city: Ferrara
country: Italy
state: Emilia-Romagna
city: Roma
country: Italy
state: Lazio
city: Catania
country: Italy
state: Sicilia
city: Massa-Carrara
country: Italy
state: Toscana
city: Aosta
country: Italy
state: Valle d'Aosta
city: Venezia
country: Italy
state: Veneto
city: Donggu,
country: Korea, Republic of
state: Gwangju Gwang''yeogsi
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Bydgoszcz
country: Poland
city: Lodz
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Linköping
country: Sweden
city: Uppsala
country: Sweden
city: St. Gallen
country: Switzerland
state: Sankt Gallen
city: Antalya
country: Turkey
city: Erzurum
country: Turkey
city: Istanbul
country: Turkey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: