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

NCT ID: NCT02727725

Last Updated: 2024-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-15

Study Completion Date

2018-01-15

Brief Summary

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* 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

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Conditions

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Myocardial Fibrosis Cardiovascular Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Traminer MRI Sequence

Intervention Type OTHER

The Traminer MRI sequence will be added to the standard IR Turbo-Flash sequence and last 2-5 minutes.

Interventions

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Traminer MRI Sequence

The Traminer MRI sequence will be added to the standard IR Turbo-Flash sequence and last 2-5 minutes.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Siemens Corporation, Corporate Technology

INDUSTRY

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nayla Chaptini, MD

Role: PRINCIPAL_INVESTIGATOR

Advocate Lutheran General Hospital

Locations

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Advocate Lutheran General Hospital

Park Ridge, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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AHC IRB 5886

Identifier Type: -

Identifier Source: org_study_id

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