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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.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02727725
Date of registration: 24/02/2016
Prospective Registration: No
Primary sponsor: Advocate Health Care
Public title: An Evaluation Of The Novel TRAMINER Sequence By Comparison To Late Gadolinium Enhancement Images
Scientific title: Establishing the Clinical Usefulness Of Dark Blood Late Gadolinium Enhancement Images For The Detection Of Small Subendocardial Left Ventricular Infarcts - An Evaluation Of The Novel TRAMINER Sequence By Comparison To Late Gadolinium Enhancement Images
Date of first enrolment: January 15, 2016
Target sample size: 100
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02727725
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
United States
Contacts
Name:     Nayla Chaptini
Address: 
Telephone:
Email:
Affiliation:  Advocate Lutheran General Hospital
Key inclusion & exclusion criteria

Inclusion Criteria:

- Adults =18 years of age referred for a cardiac MRI with Gadolinium enhancement only at
Advocate Lutheran General Hospital

Exclusion Criteria:

- <18 years old,

- Adults unable to consent

- Adults for whom the MRI has not been previously scheduled

- Adults with an order for any MRI other than cardiac MRI with Gadolinium enhancement



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Cardiovascular Disease
Myocardial Fibrosis
Intervention(s)
Other: Traminer MRI Sequence
Primary Outcome(s)
Sensitivity of the TRAMINER sequence in detecting myocardial fibrosis or acute infarction compared to the gold standard sequence will be measured. [Time Frame: 6-12 months]
Secondary Outcome(s)
Reduction in clinical Magnetic Resonance (MRI) procedure time. [Time Frame: 6-12 months]
Secondary ID(s)
AHC IRB 5886
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Siemens Corporation, Corporate Technology
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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