Gadobutrol/Gadavist-enhanced Cardiac Magnetic Resonance Imaging (CMRI) to Detect Coronary Artery Disease (CAD) Including GSPECT (Gated Single Photon Emission Computed Tomography) (GadaCAD 2)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01890434
First received: June 27, 2013
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

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.

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).

The study aims to demonstrate the non-inferior sensitivity and specificity of Gadobutrol-CMRI vs GSPECT (gated single photon emission computed tomography) for significant CAD.


Condition Intervention Phase
Coronary Artery Disease
Drug: Gadobutrol (Gadovist, BAY86-4875)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Presence of a myocardial perfusion defect indicating significant CAD [coronary artery disease] per subject on gadobutrol-enhanced CMRI [cardiac magnetic resonance imaging] (based on regional perfusion score), based on the blinded readers' assessment [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
  • Absence of a myocardial perfusion defect excluding significant CAD per subject on gadobutrol-enhanced CMRI (based on regional perfusion score), based on the blinded readers' assessment [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
  • Presence of a myocardial perfusion defect indicating significant CAD per subject on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images (based on regional perfusion/regional wall motion score), based on the blinded readers' assessment [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Presence of a myocardial perfusion defect indicating significant CAD per subject on gadobutrol-enhanced CMRI (investigator's assessment) [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
  • Absence of myocardial perfusion defect excluding significant CAD per subject on gadobutrol-enhanced CMRI (investigator's assessment) [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
  • Presence of a myocardial perfusion defect indicating significant CAD per subject on gadobutrol-enhanced CMRI versus unenhanced wall motion CMR images (investigator's assessment) [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
  • Localization of a myocardial perfusion defect to a coronary territory, i.e. LAD [left anterior descending artery] and non-LAD, on gadobutrol-enhanced CMRI (blinded readers' and investigator's assessments) [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
  • Additional localization of a non-LAD myocardial perfusion defect to RCA [right coronary artery] and LCX [left circumflex artery] territory respectively on gadobutrol-enhanced CMRI (blinded readers' and investigator's assessments) [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
  • Detection of subjects with LMS [left main stem] stenosis [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
  • Perfusion pattern of subjects with LMS stenosis [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
  • Presence/absence of a myocardial perfusion defect indicating/excluding significant CAD (per subject), in subjects with multi-vessel versus single vessel disease evaluated on gadobutrol-enhanced CMRI (blinded readers' and investigator's assessments) [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
  • Score for confidence of diagnosis for each myocardial region on unenhanced wall motion and gadobutrol-enhanced CMR images (blinded readers' and investigator's assessments) [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
  • Presence of a myocardial perfusion defect indicating significant CAD per subject on gadobutrol-enhanced CMRI versus GSPECT images (based on regional perfusion score) (blinded readers' and investigator's assessment) [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
  • Absence of a myocardial perfusion defect excluding significant CAD per subject on gadobutrol-enhanced CMRI versus GSPECT images (based on regional perfusion score) (blinded readers' and investigator's assessment) [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
  • Localization of a myocardial perfusion defect to a coronary territory, i.e. LAD and non-LAD, on gadobutrol-enhanced CMRI versus GSPECT (based on perfusion defect localization) (blinded readers' and investigator's assessment) [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: August 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gadobutrol
0.05 mmol/kg body weight (BW) as bolus injection at stress followed by 0.05 mmol/kg BW as bolus injection at rest (total dose of 0.1 mmol/kg BW) after 10 min waiting period
Drug: Gadobutrol (Gadovist, BAY86-4875)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 or CTA within 4 weeks around gadobutrol-enhanced CMRI
  • Willingness to undergo unenhanced wall motion and gadobutrol-enhanced CMRI at stress/rest and 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 m2 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01890434

  Show 25 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01890434     History of Changes
Other Study ID Numbers: 15962, 2013-000066-11
Study First Received: June 27, 2013
Last Updated: February 14, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
Singapore: Health Sciences Authority
United Kingdom: Department of Health
United States: Food and Drug Administration

Keywords provided by Bayer:
Myocardial Perfusion Imaging

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014