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:	August 26, 2013
End Date:	November 10, 2016

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

Subjects 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 subject in
the study may range from 2 days to 4-6 weeks. One to four visits to the study doctor will be
required.

The primary objective of this study is to demonstrate that sensitivity and specificity of
gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) exceed pre-specified minimum
performance thresholds of 60% and 55%, respectively, and to show superior sensitivity over
unenhanced wall motion CMRI at vasodilator rest/stress for the detection of significant CAD.
The CMR images acquired with a uniform imaging acquisition software will be evaluated either
against the results from routine clinical Coronary Angiography (CA) or Computed Tomography
Angiography (CTA), which are the standard of reference.

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

Inclusion Criteria:

- Male or female subjects aged ≥18 years

- Subjects with suspected or known CAD based on signs and/or (typical or atypical) chest
pain who have routine CA without intervention within plus/minus 4 weeks of
gadobutrol-enhanced CMRI or subjects at low risk of CAD with / or scheduled to get a
CTA for the purpose of exclusion of CAD within plus/minus 6 weeks of
gadobutrol-enhanced CMRI

- Willingness to undergo unenhanced wall motion and gadobutrol-enhanced CMRI at
stress/rest and gated single photon emission computed tomography (GSPECT, if GSPECT
will be a study procedure)

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

- Subjects who are scheduled for / have undergone routine GSPECT or undergo GSPECT as a
study procedure at stress and at rest within ± 4 weeks of gadobutrol-enhanced CMRI

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
subject 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

sites

Clinical Trial Facility in Columbus Ohio

Columbus, Ohio 43214

from

Columbus, OH