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

NCT02727725 | Completed DMC

• 1 other identifier: AHC IRB 5886
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Fibrosis; Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• Sensitivity of the TRAMINER sequence in detecting myocardial fibrosis or acute infarction compared to the gold standard sequence will be measured.

  The method of assessment is through a score using the 17 segment model of myocardial map.

  6-12 months

Secondary Outcomes (1)

• Reduction in clinical Magnetic Resonance (MRI) procedure time.

  6-12 months

Study Arms (1)

Traminer MRI Sequence

EXPERIMENTAL

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.

Other: Traminer MRI Sequence

Interventions

Traminer MRI Sequence OTHER

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

Traminer MRI Sequence

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \<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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Siemens Corporation, Corporate Technology: collaborator

Study Sites (1)

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Nayla Chaptini, MD

  Advocate Lutheran General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2016
• First Posted: April 5, 2016
• Study Start: January 15, 2016
• Primary Completion: January 15, 2018
• Study Completion: January 15, 2018
• Last Updated: October 4, 2024

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)