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

Cardiovascular Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02727725
• Other study ID #: AHC IRB 5886
• Status: Completed
• Phase: N/A
• First received: February 24, 2016
• Last updated: March 13, 2018
• Start date: January 15, 2016
• Est. completion date: January 15, 2018

Study information

• Verified date: March 2018
• Source: Advocate Health Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 15, 2018
• Est. primary completion date: January 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Myocardial Fibrosis

Intervention

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

Locations

Country	Name	City	State
United States	Advocate Lutheran General Hospital	Park Ridge	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Advocate Health Care	Siemens Corporation, Corporate Technology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Reduction in clinical Magnetic Resonance (MRI) procedure time.		6-12 months