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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02727725
Enrollment
100
Registered
2016-04-05
Start date
2016-01-15
Completion date
2018-01-15
Last updated
2024-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, Myocardial Fibrosis

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.

Interventions

OTHERTraminer MRI Sequence

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

Sponsors

Siemens Corporation, Corporate Technology
CollaboratorINDUSTRY
Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Reduction in clinical Magnetic Resonance (MRI) procedure time.6-12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026