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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2010-020775-22-DE |
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Date of registration:
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14/07/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Assessment of myocardial viability using reduced doses of contrast agent (GV Via) - GV-Via
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Scientific title:
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Assessment of myocardial viability using reduced doses of contrast agent (GV Via) - GV-Via |
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Date of first enrolment:
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10/08/2010 |
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Target sample size:
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Recruitment status: |
Authorised-recruitment may be ongoing or finished |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-020775-22 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
Other trial design description: prospective single center
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: different doses
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
- Patients between 18 and 80 years of age
- Chronic myocardial infarction based on a coronary artery disease, detected by cardiac catheterization
- Successfully performed clinical LGE CMR study within the last 4 weeks for chronic myocardial infarction (> 3 months old)
- Evidence of single myocardial infarction on LGE CMR with ?hyper-enhancement? involving at least 2 contiguous short-axis slices
- Written informed consent
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
- History of moderate or severe impairment of renal function or glomerular filtration rate (GFR) <30 ml/min/m2 on blood test
- Additional myocardial infarction or acute coronary syndrome during the last 4 weeks
- History of other myocardial disease such as hypertrophic cardiomyopathy, myocarditis
- known allergy to contrast agents containing gadolinium
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Patients with a history of chronic myocardial infarction due to coronary artery disease and a successful LGE-CMR scan.
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Intervention(s)
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Trade Name: Gadovist 1.0mmol/ml
Pharmaceutical Form: Solution for injection
CAS Number: 138071-82-6
Other descriptive name: GADOBUTROL
Concentration unit: mmol/ml millimole(s)/millilitre
Concentration type: equal
Concentration number: 1,0-
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Primary Outcome(s)
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Secondary Objective: To assess the contrast kinetics of gadobutrol in infarcted and in remote myocardium.
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Main Objective: To determine the accuracy of Late Gadolinium Enhancement (LGE) viability Cardiac Magnetic Resonance (CMR) imaging using reduced doses of gadobutrol.
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Primary end point(s): The accuracy of Late Gadolinium Enhancement (LGE) viability Cardiac Magnetic Resonance (CMR) imaging using reduced doses of gadobutrol.
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Secondary ID(s)
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IT2191002
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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