Gadobutrol/Gadavist-enhanced Cardiac Magnetic Resonance Imaging (CMRI) to Detect Coronary Artery Disease (CAD)



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:5/18/2018
Start Date:July 19, 2013
End Date:August 31, 2017

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Trial Summary
Trial Overview
Inclusion Criteria

Multicenter Open-label Study to Evaluate Efficacy of Gadobutrol-enhanced Cardiac Magnetic Resonance Imaging (CMRI) for Detection of Significant Coronary Artery Disease (CAD) in Subjects With Known or Suspected CAD by a Blinded Image Analysis

Participants being evaluated for suspected or known Coronary artery Disease (CAD) based on
signs and/or symptoms, will be invited to participate in the study. The duration for a
participant in the study may range from 2 days to 4-6 weeks. One to four visits to the study
doctor will be required.

This study will investigate the diagnostic results of gadobutrol-enhanced Cardiac Magnetic
Resonance Imaging (CMRI) images regarding the detection (sensitivity) and exclusion
(specificity) of coronary artery disease utilizing a uniform image acquisition software. The
CMR images will be tested either against the results from routine clinical Coronary
Angiography (CA) or those from Computed Tomography Angiography (CTA), which is used as the
standard of reference. The CA/CTA may have been performed up to 4 weeks prior to enrollment
or be scheduled up to 4/6 weeks after the study.

CMRI and CA/CTA images will be collected for an independent image review (blinded read).


Inclusion Criteria:

- Male or female participants aged ≥18 years

- Participants with suspected or known CAD based on signs and/or (typical or atypical)
chest pain who have routine CA without intervention or CTA within 4 weeks around
gadobutrol-enhanced CMRI

- Willingness to undergo stress/rest CMRI and to follow directions and complete all
study procedures

- Women of childbearing potential (e.g. age < 60y, no history of surgical sterilization
or hysterectomy): use of contraception and a negative pregnancy test

Exclusion Criteria:

- Suspected clinical instability or unpredictability of the clinical course during the
study period

- Contraindication to the cardiac MRI examination (e.g. inability to hold breath; severe
claustrophobia, metallic devices such as pace makers)

- History of severe allergic or anaphylactoid reaction to any allergen including drugs
and contrast agents according to the investigator's assessment / judgment

- Estimated glomerular filtration rate (eGFR) value <30 mL/min/1.73 m^2 derived from a
serum / blood creatinine result within 2 weeks prior to gadobutrol injection. Any
participant on hemodialysis or peritoneal dialysis is excluded from enrollment.

- Acute renal insufficiency

- Coronary artery bypass grafting (CABG)

- Acute myocardial infarction (< 14 days prior to inclusion), unstable angina / acute
coronary syndrome, severe congestive heart failure

- Irregular heart rhythm

- Condition that precludes the safe administration of pharmacological stressor according
to the respective approved label such as sinus node disease, 2nd or 3rd degree
atrioventricular block, obstructive lung disease
We found this trial at
2
sites
Clinical Trial Facility in Marseille
Marseille, 13385
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from
Marseille,
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Clinical Trial Facility in Minneapolis Minnesota
Minneapolis, Minnesota 55455
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from
Minneapolis, MN
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