Phase
Condition
Coronary Artery Disease
Vascular Diseases
Cardiovascular Disease
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female subjects aged ≥18 years
Subjects with suspected or known CAD based on signs and/or (typical or atypical) chestpain who have routine CA without intervention within plus/minus 4 weeks ofgadobutrol-enhanced CMRI or subjects at low risk of CAD with / or scheduled to get aCTA for the purpose of exclusion of CAD within plus/minus 6 weeks ofgadobutrol-enhanced CMRI
Willingness to undergo unenhanced wall motion and gadobutrol-enhanced CMRI atstress/rest and gated single photon emission computed tomography (GSPECT, if GSPECTwill be a study procedure)
Women of childbearing potential (e.g. age < 60y, no history of surgical sterilizationor hysterectomy): use of contraception and a negative pregnancy test
Subjects who are scheduled for / have undergone routine GSPECT or undergo GSPECT as astudy procedure at stress and at rest within ± 4 weeks of gadobutrol-enhanced CMRI
Exclusion
Exclusion Criteria:
Suspected clinical instability or unpredictability of the clinical course during thestudy period
Contraindication to the cardiac MRI examination (e.g. inability to hold breath; severeclaustrophobia, metallic devices such as pace makers)
History of severe allergic or anaphylactoid reaction to any allergen including drugsand contrast agents according to the investigator's assessment / judgment
Estimated glomerular filtration rate (eGFR) value <30 mL/min/1.73 m^2 derived from aserum / blood creatinine result within 2 weeks prior to gadobutrol injection. Anysubject 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 / acutecoronary syndrome, severe congestive heart failure
Irregular heart rhythm
Condition that precludes the safe administration of pharmacological stressor accordingto the respective approved label such as sinus node disease, 2nd or 3rd degreeatrioventricular block, obstructive lung disease
Study Design
Connect with a study center
Adelaide, South Australia 5042
AustraliaSite Not Available
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Melbourne, Victoria 3065
AustraliaSite Not Available
Perth, Western Australia 6000
AustraliaSite Not Available
Chermside, 4032
AustraliaSite Not Available
North Adelaide, 5006
AustraliaSite Not Available
London, Ontario N6A 5A5
CanadaSite Not Available
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Toronto, Ontario M5G 2N2
CanadaSite Not Available
Montreal, Quebec H1T 1C8
CanadaSite Not Available
Singapore,
SingaporeSite Not Available
Tucson, Arizona 85724
United StatesSite Not Available
Los Angeles, California 90048-0750
United StatesSite Not Available
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New Haven, Connecticut 06520--804
United StatesSite Not Available
Atlanta, Georgia 30322
United StatesSite Not Available
Chicago, Illinois 60611-2908
United StatesSite Not Available
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Baltimore, Maryland 21287-4010
United StatesSite Not Available
Bethesda, Maryland 20814
United StatesSite Not Available
Boston, Massachusetts 02114
United StatesSite Not Available
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Minneapolis, Minnesota 55455
United StatesSite Not Available
Saint Louis, Missouri 63110
United StatesSite Not Available
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St. Louis, Missouri 63110
United StatesSite Not Available
Durham, North Carolina 27710
United StatesSite Not Available
Cleveland, Ohio 44195
United StatesSite Not Available
Columbus, Ohio 43210
United StatesSite Not Available
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Tulsa, Oklahoma 74133
United StatesSite Not Available
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Charleston, South Carolina 29425
United StatesSite Not Available
Houston, Texas 77030
United StatesSite Not Available
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Salt Lake City, Utah 84132
United StatesSite Not Available
Charlottesville, Virginia 22908
United StatesSite Not Available
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