Trial Condition(s):

Coronary artery disease

Gadobutrol / Gadavist-enhanced cardiac magnetic resonance imaging (CMRI) to detect Coronary Artery Disease (CAD) (GadaCAD 2)

Bayer Identifier:

15962

ClinicalTrials.gov Identifier:

NCT01890434

EudraCT Number:

2013-000066-11

Study Completed

Trial Purpose

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

Trial Summary

Enrollment Goal
478
Trial Dates
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Phase
3
Could I receive a placebo?
No
Products
Gadavist/Gadovist (Gadobutrol, BAY86-4875)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Montreal, Canada, H1T 1C8

Status
Completed
 
Locations

Investigative Site

London, Canada, N6A 5A5

Status
Completed
 
Locations

Investigative Site

Bethesda, United States, 20892

Status
Completed
 
Locations

Investigative Site

Chicago, United States, 60611-2908

Status
Completed
 
Locations

Investigative Site

Cleveland, United States, 44195

Status
Completed
 
Locations

Investigative Site

Philadelphia, United States, 19104

Status
Completed
 
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Investigative Site

Boston, United States, 02114

Status
Completed
 
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Investigative Site

Charlottesville, United States, 22908

Status
Completed
 
Locations

Investigative Site

St. Louis, United States, 63110

Status
Completed
 
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Investigative Site

Perth, Australia, 6000

Status
Completed
 
Locations

Investigative Site

North Adelaide, Australia, 5006

Status
Completed
 
Locations

Investigative Site

Chermside, Australia, 4032

Status
Completed
 
Locations

Investigative Site

Adelaide, Australia, 5042

Status
Completed
 
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Investigative Site

Los Angeles, United States, 90048-0750

Status
Completed
 
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Investigative Site

Tucson, United States, 85724

Status
Completed
 
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Investigative Site

Houston, United States, 77030

Status
Completed
 
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Investigative Site

Singapore, Singapore

Status
Completed
 
Locations

Investigative Site

Singapore, Singapore, 168752

Status
Completed
 
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Investigative Site

Durham, United States, 27710

Status
Completed
 
Locations

Investigative Site

Bethesda, United States, 20814

Status
Completed
 
Locations

Investigative Site

Columbus, United States, 43210

Status
Completed
 
Locations

Investigative Site

Charleston, United States, 29425

Status
Completed
 
Locations

Investigative Site

Atlanta, United States, 30322

Status
Completed
 
Locations

Investigative Site

Montreal, Canada, H4A 3J1

Status
Completed
 

Trial Design