Gadobutrol/Gadavist-enhanced cardiac magnetic resonance imaging (CMRI) to detect Coronary Artery Disease (CAD)

Phase 1

• Conditions: Subjects with known or suspected Coronary Artery Disease (CAD); Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2012-002563-10-GB
• Lead Sponsor: Bayer AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-19
• Study Completion: 2017-08-31
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 426

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 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 135
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 315

Exclusion Criteria

- Pregnant or nursing (including pumping for storage and feeding)
- Received any other investigational product or participation in any other interventional clinical study within 15 days prior to enrollment in this study
- Suspected clinical instability or unpredictability of the clinical course during the study period
- Any scheduled procedure such as interventional (PCI, stenting) or surgical treatment that may alter/may have altered the cardiac condition regarding myocardial perfusion status and/or stenosis degree between CMRI and CA or CTA.
- Any contrast agent +/- 24 h prior to or after gadobutrol-enhanced CMRI (i.e. ensure minimum interval of 24 h between the SoR and the CMRI). This does not apply for emergency CA.
- Contraindication to the cardiac MRI examination (e.g. inability to hold breath; severe arrhythmias preventing gated acquisition; very low cardiac output, severe claustrophobia, defibrillators or other metallic devices not approved for MRI, 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
- Previous enrollment into this study or any other Bayer-sponsored study using gadobutrol
- Coronary artery bypass grafting (CABG)
- Acute myocardial infarction (< 14 days prior to inclusion), unstable angina / acute coronary syndrome, severe congestive heart failure, decompensated heart failure with ejection fraction <35%
- 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
- Uncontrolled and severe hypertension
- Baseline hypotension
- Subject has a close affiliation with the investigational site; e.g. a relative of the investigator, or a dependent person.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified