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Main
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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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ISRCTN |
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Last refreshed on:
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1 April 2019 |
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Main ID: |
ISRCTN48802295 |
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Date of registration:
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10/07/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Comparison of different techniques regarding visualization of scars in the heart muscle using cardiac MRI
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Scientific title:
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Comparison of fast multi-slice and standard segmented techniques for detection of late gadolinium enhancement in ischemic and non-ischemic cardiomyopathy - a prospective clinical trial |
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Date of first enrolment:
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01/11/2014 |
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Target sample size:
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302 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN48802295 |
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Study type:
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Observational |
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Study design:
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Observational cohort study (Diagnostic)
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Phase:
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Not Applicable
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Countries of recruitment
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Germany
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Jeanette
Schulz-Menger |
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Address:
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Charité University Medicine Berlin
Campus Buch
Working Group Kardiale MRT
Lindenberger Weg 80
13125
Berlin
Germany |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Known or suspected chronic myocardial infarction, hypertrophic cardiomyopathy or inflammatory heart disease
2. Clinical indication for MR exam with late gadolinium enhancement
3. Age range =18 years (no upper limit)
Exclusion criteria:
1. Any contraindication for MR exam
2. Acute or chronic renal failure with GFR <30ml/min
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Myocardial infarction, hypertrophic cardiomyopathy and inflammatory heart disease
Circulatory System
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Intervention(s)
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This is an observational study in which three different techniques are compared for visualization of myocardial fibrosis using late Gadolinium enhancement in patients with known or suspected cardiomyopathy.
Patients sent for clinically indicated cardiac LGE-based MRI with known or suspected LGE due to chronic infarction, inflammatory myocardial disease and hypertrophic cardiomyopathy (HCM) are prospectively recruited. The indication for the MRI itself is clinical. However, for this study the MRI protocol is extended by the tested multislice LGE sequences for approximately 5 extra minutes. LGE images are acquired using three different LGE sequences. All patients were scanned with all three LGE sequences (intraindividual comparison). All LGE sequences are then assessed as follows: image quality is evaluated with a 4-point scoring system. Contrast-to-noise ratios and acquisition time are measured. Size of LGE is quantitatively assessed using a semi-automated threshold method. All assessments are done by blinded readers.
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Primary Outcome(s)
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Size of myocardium with late Gadolinium enhancement in each tested MR sequence, measured by semiautomated threshold method in MRI DICOM data at one timepoint, the date of the MRI (no follow up)
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Secondary Outcome(s)
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1. Contrast-to-noise ratio in each tested MR sequence, measured using MRI DICOM data
2. Image quality, scored on a 4-point-scaling system based on visual assessment by blinded readers
Measured at at one timepoint, the date of the MRI (no follow up)
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Secondary ID(s)
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LGE COMPARE (internal study code)
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Source(s) of Monetary Support
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Charité Universitätsmedizin Berlin
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Ethics review
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Status:
Approval date:
Contact:
Ethics board at Charité University Medicine Berlin, Campus Mitte, 16/10/2014, ref: EA1/305/14
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/12/2016 |
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URL:
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