- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01655290
Comparison of Gadobutrol and Gadobenate Dimeglumin for Delayed Enhancement Cardiac MRI (Gadovit)
October 20, 2020 updated by: Technical University of Munich
Single Dose Gadobutrol in Comparison to Single Dose Gadobenate Dimeglumine for Magnetic Resonance Imaging of Chronic Myocardial Infarction at 3 Tesla
This study aims at evaluating the diagnostic efficacy of Gadobutrol versus Gadobenate dimeglumine at similar dose of 0.1mmol/kg for assessment of myocardial infarction by delayed enhancement cardiac Magnetic Resonance Imaging
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bavaria
-
Munic, Bavaria, Germany, 81675
- Institut für Radiologie - Klinikum Rechts der Isar
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of myocardial infarction
- Age ≥ 18 years and ≤ 80 years
- Informed consent
- Male patients as well as female patients using contraceptives
Exclusion Criteria:
- Patients with a heart pacemaker, with magnetic material or other magnetic implants.
- Renal failure (GFR <30ml/min)
- Patients with known allergy to a Gadolinium-containing contrast agent
- Drugs or alcohol addiction, dementia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Gadobutrol
first session gadobutrol second session gadobenate dimeglumin
|
Other (Diagnostic)
|
Experimental: Demeglumin
first session gadobenate dimeglumin second session gadobutrol
|
Other (Diagnostic)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Efficacy (contrast-to-noise ratio)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
July 30, 2012
First Submitted That Met QC Criteria
July 30, 2012
First Posted (Estimate)
August 1, 2012
Study Record Updates
Last Update Posted (Actual)
October 22, 2020
Last Update Submitted That Met QC Criteria
October 20, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GAD-1140-WIL-0020-I
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Subacute/Chronic Myocardial Infarction
-
Ageless Regenerative InstituteWithdrawn
-
VZW Cardiovascular Research Center AalstRecruitingNon ST Elevation Myocardial Infarction | Chronic Coronary InsufficiencyUnited Kingdom, United States, Australia, Belgium, Italy, Japan
-
Hospices Civils de LyonCompletedChronic Heart Failure | Acute Myocardial InfarctionFrance
-
Sakakibara Heart InstituteCellBank of JapanUnknownChronic Heart Failure | Old Myocardial InfarctionJapan
-
Azienda ULSS 5 PolesanaUniversity of PadovaUnknownMyocardial Infarction, Acute | ST Segment Elevation Myocardial Infarction | Non-ST Elevation Myocardial Infarction (nSTEMI)Italy
-
University Medical Centre LjubljanaCompletedCardiac Arrest | Postresuscitation Syndrome | Myocardial Infarction (ST-Elevation Myocardial Infarction and Non-ST-Elevation Myocardial Infarction)Slovenia
-
Fundacio Privada Mon Clinic BarcelonaMiracor Medical SANot yet recruiting
-
Stiftung Institut fuer HerzinfarktforschungGlaxoSmithKline; University Hospital Muenster; Klinikum NürnbergCompletedMyocardial Infarction | ST-Elevation Myocardial Infarction | Non-ST-Elevation Myocardial InfarctionGermany
-
Population Health Research InstituteCanadian Institutes of Health Research (CIHR); Boston Scientific CorporationActive, not recruitingST Elevation Myocardial Infarction | Non ST Elevation Myocardial InfarctionCanada
-
Bispebjerg HospitalOdense University Hospital; Zealand University Hospital; Hvidovre University... and other collaboratorsRecruitingST Elevation Myocardial Infarction | Acute Myocardial Infarction | Non-ST Elevation Myocardial Infarction (nSTEMI)Denmark
Clinical Trials on Gadovist® (Gadobutrol), Multihance® (Gadobenate dimeglumin)
-
BayerCompletedNeoplastic CNS LesionsItaly
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedLymphoma | Brain Neoplasm | Metastatic Malignant Neoplasm in the Brain | Recurrent Malignant Brain NeoplasmUnited States
-
GuerbetCompletedPrimary Brain TumorColombia, Korea, Republic of, United States, Mexico
-
University Hospital, GrenobleNot yet recruitingInner Ear ; Meniere's Disease; Imaging
-
GuerbetBayer AG (Sponsor); Bracco (Sponsor); GEHC (Sponsor)RecruitingCognitive Function | Motor Function | Contrast MediaUnited States, Korea, Republic of, Italy, Brazil, Canada, Russian Federation
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMultiple Sclerosis | Metastatic Malignant Neoplasm in the Brain | Adult Anaplastic Astrocytoma | Adult Anaplastic Ependymoma | Adult Anaplastic Oligodendroglioma | Adult Diffuse Astrocytoma | Adult Ependymoma | Adult Giant Cell Glioblastoma | Adult Glioblastoma | Adult Gliosarcoma | Adult Mixed Glioma | Adult... and other conditionsUnited States
-
Dipan ShahGuerbetUnknownCoronary Artery Disease | Cardiomyopathy
-
Northwestern UniversityNational Cancer Institute (NCI)Not yet recruitingProstate CarcinomaUnited States