Gadobutrol/Gadavist-enhanced Cardiac Magnetic Resonance Imaging (CMRI) to Detect Coronary Artery Disease (CAD)
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Intervention: Gadobutrol (Gadovist, Gadavist, BAY86-4875)
Intervention description: Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 426.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Myocardial Perfusion Imaging

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 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 around
             gadobutrol-enhanced CMRI

          -  Willingness to undergo stress/rest CMRI and to follow directions and complete all
             study procedures

          -  Women of childbearing potential (e.g. age < 60y, no history of surgical sterilization
             or hysterectomy): use of contraception and a negative pregnancy test

        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
             participant 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