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

Last updated: July 18, 2019
Sponsor: Bayer
Overall Status: Completed

Phase

3

Condition

Coronary Artery Disease

Vascular Diseases

Cardiovascular Disease

Treatment

N/A

Clinical Study ID

NCT01890434
15962
2013-000066-11
  • Ages > 18
  • All Genders

Study Summary

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).

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

Total Participants: 478
Study Start date:
August 26, 2013
Estimated Completion Date:
November 10, 2016

Connect with a study center

  • Adelaide, South Australia 5042
    Australia

    Site Not Available

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    Melbourne, Victoria 3065
    Australia

    Site Not Available

  • Perth, Western Australia 6000
    Australia

    Site Not Available

  • Chermside, 4032
    Australia

    Site Not Available

  • North Adelaide, 5006
    Australia

    Site Not Available

  • London, Ontario N6A 5A5
    Canada

    Site Not Available

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    Toronto, Ontario M5G 2N2
    Canada

    Site Not Available

  • Montreal, Quebec H1T 1C8
    Canada

    Site Not Available

  • Singapore,
    Singapore

    Site Not Available

  • Tucson, Arizona 85724
    United States

    Site Not Available

  • Los Angeles, California 90048-0750
    United States

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    New Haven, Connecticut 06520--804
    United States

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  • Atlanta, Georgia 30322
    United States

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  • Chicago, Illinois 60611-2908
    United States

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    Baltimore, Maryland 21287-4010
    United States

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  • Bethesda, Maryland 20814
    United States

    Site Not Available

  • Boston, Massachusetts 02114
    United States

    Site Not Available

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    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Saint Louis, Missouri 63110
    United States

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    St. Louis, Missouri 63110
    United States

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  • Durham, North Carolina 27710
    United States

    Site Not Available

  • Cleveland, Ohio 44195
    United States

    Site Not Available

  • Columbus, Ohio 43210
    United States

    Site Not Available

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    Tulsa, Oklahoma 74133
    United States

    Site Not Available

  • Philadelphia, Pennsylvania 19104
    United States

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  • Charleston, South Carolina 29425
    United States

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  • Houston, Texas 77030
    United States

    Site Not Available

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    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Charlottesville, Virginia 22908
    United States

    Site Not Available

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