Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2012-002563-10-GB
EUCTR2012-002563-10-GB
Active, not recruiting
Phase 1

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 - GadaCAD 1

Bayer AG0 sites426 target enrollmentApril 19, 2013
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsSubjects with known or suspected Coronary Artery Disease (CAD)Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
DrugsGadovist® 1.0mmol/ml, solution for injection

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Subjects with known or suspected Coronary Artery Disease (CAD)
Sponsor
Bayer AG
Enrollment
426
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 19, 2013
End Date
August 31, 2017
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
Bayer AG

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 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

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Phase 1
Gadobutrol/Gadavist-enhanced cardiac magnetic resonance imaging (CMRI) to detect Coronary Artery Disease (CAD)
EUCTR2012-002563-10-DEBayer HealthCare AG450
Active, not recruiting
Phase 1
Gadobutrol/Gadavist-enhanced cardiac magnetic resonance imaging (CMRI) to detect Coronary Artery Disease (CAD)Subjects with known or suspected Coronary Artery Disease (CAD)Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
EUCTR2012-002563-10-FRBayer HealthCare AG450
Unknown
Phase 3
Bosentan for PAH pediatric patientsPulmonary arterial hypertension (PAH)
JPRN-jRCT2080222108Actelion Pharmaceuticals Japan Ltd.5
Active, not recruiting
Not Applicable
A multicenter, open-label study on the efficacy, cycle control and safety of a contraceptivevaginal ring delivering a daily dose of 150 µg of Nestorone(R) and 15 µg of ethinyl estradiol (150/15 NES/EE CVR)As the trial is intended to investigate a new contraceptive medicinal product, the study subjects included are not characterized by a specific medical condition.MedDRA version: 8.1Level: PTClassification code 10010808Term: Contraception
EUCTR2005-004978-25-HUInternational Committee for Contraception Research of the Population Council2,200
Active, not recruiting
Not Applicable
A multicenter, open-label study on the efficacy, cycle control and safety of a contraceptivevaginal ring delivering a daily dose of 150 µg of Nestorone(R) and 15 µg of ethinyl estradiol (150/15 NES/EE CVR)As the trial is intended to investigate a new contraceptive medicinal product, the study subjects included are not characterized by a specific medical condition.MedDRA version: 8.1Level: PTClassification code 10010808Term: Contraception
EUCTR2005-004978-25-SEInternational Committee for Contraception Research of the Population Council2,200