Overview

This trial has been completed.

Condition coronary artery disease
Treatment gadobutrol (gadovist, bay86-4875)
Phase phase 3
Sponsor Bayer
Start date August 2013
End date August 2016
Trial size 485 participants
Trial identifier NCT01890434, 15962, 2013-000066-11

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
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
gadobutrol (gadovist, bay86-4875)

Primary Outcomes

Measure
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
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
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

Secondary Outcomes

Measure
Presence of a myocardial perfusion defect indicating significant CAD per subject on gadobutrol-enhanced CMRI (investigator's assessment)
time frame: Up to 8 weeks
Absence of myocardial perfusion defect excluding significant CAD per subject on gadobutrol-enhanced CMRI (investigator's assessment)
time frame: Up to 8 weeks
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
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
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
Detection of subjects with LMS [left main stem] stenosis
time frame: Up to 8 weeks
Perfusion pattern of subjects with LMS stenosis
time frame: Up to 8 weeks
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
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
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
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
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

Eligibility Criteria

Male or female participants at least 18 years old.

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 prupose of exclusion of CDA within plus/minus 6 weeks of 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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Bayer.