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

Last updated: April 17, 2018
Sponsor: Bayer
Overall Status: Completed

Phase

3

Condition

Coronary Artery Disease

Myocardial Ischemia

Cardiovascular Disease

Treatment

N/A

Clinical Study ID

NCT01890421
15961
2012-002563-10
  • Ages > 18
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

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 aroundgadobutrol-enhanced CMRI

  • Willingness to undergo stress/rest CMRI and to follow directions and complete allstudy procedures

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

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. Anyparticipant 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: 426
Study Start date:
July 19, 2013
Estimated Completion Date:
August 31, 2017

Connect with a study center

  • Marseille, 13385
    France

    Site Not Available

  • Saint-Etienne, 42055
    France

    Site Not Available

  • Bad Krozingen, Baden-Württemberg 79189
    Germany

    Site Not Available

  • empty

    Mannheim, Baden-Württemberg 68167
    Germany

    Site Not Available

  • Stuttgart, Baden-Württemberg 70376
    Germany

    Site Not Available

  • Tuebingen, Baden-Württemberg 72076
    Germany

    Site Not Available

  • empty

    Tübingen, Baden-Württemberg 72076
    Germany

    Site Not Available

  • empty

    Würzburg, Bayern 97080
    Germany

    Site Not Available

  • Darmstadt, Hessen 64287
    Germany

    Site Not Available

  • Göttingen, Niedersachsen 37075
    Germany

    Site Not Available

  • Bonn, Nordrhein-Westfalen 53115
    Germany

    Site Not Available

  • Essen, Nordrhein-Westfalen 45122
    Germany

    Site Not Available

  • Leipzig, Sachsen 04289
    Germany

    Site Not Available

  • Berlin, 10709
    Germany

    Site Not Available

  • empty

    Gyeongnam, Korea
    Korea, Republic of

    Site Not Available

  • Incheon, 21565
    Korea, Republic of

    Site Not Available

  • empty

    Incheon,, 405-760
    Korea, Republic of

    Site Not Available

  • Seoul, 05505
    Korea, Republic of

    Site Not Available

  • Yangsan-si, 50612
    Korea, Republic of

    Site Not Available

  • Auckland,
    New Zealand

    Site Not Available

  • Lugano, Ticino 6900
    Switzerland

    Site Not Available

  • empty

    Bern, 3010
    Switzerland

    Site Not Available

  • empty

    Zürich, 8091
    Switzerland

    Site Not Available

  • empty

    Bristol, BS2 8HW
    United Kingdom

    Site Not Available

  • empty

    Dundee, DD1 9SY
    United Kingdom

    Site Not Available

  • Leicester, LE3 9QP
    United Kingdom

    Site Not Available

  • Liverpool, L14 3PE
    United Kingdom

    Site Not Available

  • London, SW3 6NP
    United Kingdom

    Site Not Available

  • Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • empty

    Providence, Rhode Island 02903-4900
    United States

    Site Not Available

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