An Evaluation Of The Novel TRAMINER Sequence By Comparison To Late Gadolinium Enhancement Images

Not Applicable

Completed

• Conditions: Myocardial Fibrosis; Cardiovascular Disease
• Interventions: Other: Traminer MRI Sequence

• Registration Number: NCT02727725
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

* The purpose of this study is to show that the novel TRAMINER (T(Rho) and Magnetization Transfer and Inversion Recovery) sequence provides at least as good visualization and detection of sub-endocardial scarring, fibrosis, and acute infarction as the current gold standard Inversion Recovery (IR) Turbo-Flash sequence.

* The hypothesis is that the TRAMINER sequence has the same or higher sensitivity in detecting small sub-endocardial scarring than the inversion recovery segmented gradient echo sequence known as IR-Turbo Fast low angle shot (IR Turbo-Flash), which is the accepted current gold standard for the detection of myocardial viability.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-15
• Study First Submitted: 2016-02-24
• Study First Submitted QC: 2016-03-30
• Study First Posted: 2016-04-05
• Primary Completion: 2018-01-15
• Study Completion: 2018-01-15
• Status Verified: 2018-03
• Last Update Submitted: 2024-10-02
• Last Update Posted: 2024-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Traminer MRI Sequence	Traminer MRI Sequence	The TRAMINER MRI sequence implementation to be tested allows the acquisition of high resolution MR images in the free-breathing patient, by combining multiple averages and motion correction with the TRAMINER preparation.

Primary Outcome Measures

Name	Time	Method
Sensitivity of the TRAMINER sequence in detecting myocardial fibrosis or acute infarction compared to the gold standard sequence will be measured.	6-12 months	The method of assessment is through a score using the 17 segment model of myocardial map.

Secondary Outcome Measures

Name	Time	Method
Reduction in clinical Magnetic Resonance (MRI) procedure time.	6-12 months

Trial Locations

Locations (1)

Advocate Lutheran General Hospital; 🇺🇸 Park Ridge, Illinois, United States