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 (Gadavist, Gadovist, 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: 478.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Myocardial Perfusion Imaging

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 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