Gadobutrol/Gadavist-enhanced Cardiac Magnetic Resonance Imaging (CMRI) to Detect Coronary Artery Disease (CAD)

NCT ID: NCT01890421

Last Updated: 2018-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 426 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-19
• Study Completion Date: 2017-08-31

Brief 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).

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Gadobutrol 0.1 mmol/kg body weight

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.

Group Type: EXPERIMENTAL

Gadobutrol (Gadovist, Gadavist, BAY86-4875)

Intervention Type: DRUG

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.

Interventions

Gadobutrol (Gadovist, Gadavist, BAY86-4875)

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Minneapolis, Minnesota, United States

Marseille, , France

Saint-Etienne, , France

Bad Krozingen, Baden-Wurttemberg, Germany

Stuttgart, Baden-Wurttemberg, Germany

Tübingen, Baden-Wurttemberg, Germany

Darmstadt, Hesse, Germany

Göttingen, Lower Saxony, Germany

Bonn, North Rhine-Westphalia, Germany

Essen, North Rhine-Westphalia, Germany

Leipzig, Saxony, Germany

Berlin, , Germany

Berlin, , Germany

Berlin, , Germany

Auckland, , New Zealand

Incheon, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Yangsan, , South Korea

Lugano, Canton Ticino, Switzerland

Leicester, , United Kingdom

Liverpool, , United Kingdom

London, , United Kingdom

Countries

United States; France; Germany; New Zealand; South Korea; Switzerland; United Kingdom

Related Links

http://www.clinicaltrialsregister.eu/

Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

Other Identifiers

2012-002563-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

15961

Identifier Type: -

Identifier Source: org_study_id