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Completed

NCT Number: NCT02727725

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

* 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.

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Key information

Conditions

Myocardial Fibrosis Cardiovascular Disease Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Traminer MRI Sequence

Other

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

Primary outcomes

  1. 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

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

Secondary outcomes

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

    Time frame: 6-12 months

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Siemens Corporation, Corporate Technology

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 5, 2016
Registry last updated
Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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