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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

Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Oct 2020

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At a glance

  • Drugs Gadobutrol (Primary)
  • Indications Coronary artery disease
  • Focus Diagnostic use
  • Acronyms GadaCAD 1
  • Sponsors Bayer
  • Most Recent Events

    • 02 Oct 2020 According to a Bayer media release, The Journal of the American College of Cardiology published results of the Phase III GadaCAD 1 and GadaCAD 2 clinical trials for Gadavist (gadobutrol) in their 29th September 2020 issue.The publication includes data that supported the FDA approval of Gadavist to assess myocardial perfusion (stress, rest) and late gadolinium enhancement (LGE) in adult patients with known or suspected coronary artery disease (CAD).
    • 29 Sep 2020 Results of pooled analysis of data from GadaCAD 1 and GadaCAD 2 assessing the sensitivity and specificity of gadobutrol for detection of CAD by assessing myocardial perfusion and late gadolinium enhancement imaging, published in the Journal of the American College of Cardiology
    • 15 Jul 2019 According to a Bayer media release, Food and Drug Administration has approved Gadavist injection for use in cardiac magnetic resonance in adult patients with known or suspected coronary artery disease.The approval was based on two multinational, non-randomized, blinded-read Phase 3 studies(NCT01890421 and NCT01890434)
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