Non-Enhanced Magnetic Resonance Angiography With the t-SLIP Technique (MRAtSLIP)

The purpose of the study is to create MR images using an investigative technique called pulse sequences with new computer software programs. The sequence will allow us to image vessels without injecting contrast agents.

Study Overview

• Status: Terminated
• Conditions: Focus of Study is MRI

Detailed Description

The t-SLIP Investigational Study Sequences are designed to compare t-SLIP to standard MR contrast enhanced imaging techniques to establish the diagnosic benefits of t-SLIP compared to contrast enhanced MR techniques. The t-SLIP Investigational Study Sequences will be used for vascular MRI Imaging including, but no limited to, MRA of the renal, mesenteric, abdominal aortic, iliac and femoral arteries. We will be targeting all adult patients undergoing standard body MRA examinations without anesthesia.

The time spatial labeling inversion pulse (t-SLIP) technique is used for non contrast enhanced MR angiography imaging. It produces bright blood spin labeling images by using a single acquisition with a combination of a spatially nonselective inversion pulse and a spatially selective inversion pulse. The nonselective pulse inverts the magnetization of the entire imaging area. The spatially selective pulse, applied upstream of the arteries of interest, reverts those protons to full magnetization. A pre defined time delay between tagging and imaging allows the tagged spins to reach the imaging region and suppresses background tissue within the imaging region to some extent.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

• Study Contact: Name: Raul Herrera, MD; Phone Number: 786-596-3505; Email: raulh@baptisthealth.net
• Study Contact Backup: Name: Constantino Pena, MD; Phone Number: 786-596-5990; Email: constantinop@baptisthealth.net

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33176
      • Baptist Cardiac and Vascular Institute
    • Miami, Florida, United States, 33176
      • Miami Cardiac and Vascular Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All Patients Needing Thoracic, Aortic, Renal, Iliac and/or Femoral Vasculature MRIs

Description

Inclusion Criteria:

• All patients that are considered candidates and scheduled for standard contrast enhanced MRA can be included in the study.

Exclusion Criteria:

• Patients that can not undergo standard MRA

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Standard Sequence Imaging MRI; Patients requiring MRI. All Comers accepting study participation.
Additional Pulse Sequence Increased; Patients requiring MRI. All comers accepting study participation and the run of additional pulse sequences during MRI procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of enhancement by evaluation of the Thoracic, Aortic, Renal, Iliac and Femoral Vasculature Images	The project proposal is to acquire the additional sequence as part of the standard examination and then to compare the sequence to the standard MR contrast enhanced imaging techniques in order to establish the diagnostic benefits of this sequence compared to contrast enhanced MR techniques.	2 Years

Collaborators and Investigators

• Sponsor: Miami Cardiac and Vascular Institute
• Investigators: Principal Investigator: Constantino Pena, MD, Baptist Cardiac and Vascular Institute

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2013
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: January 8, 2014
• First Submitted That Met QC Criteria: January 8, 2014
• First Posted (Estimate): January 10, 2014

Study Record Updates

• Last Update Posted (Actual): April 3, 2023
• Last Update Submitted That Met QC Criteria: March 29, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: MRI, Angiography, Pulse Sequence
• Other Study ID Numbers: 2013-020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO