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

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ClinicalTrials.gov Identifier: NCT02032940
Recruitment Status : Unknown
Verified March 2016 by Constantino Pena, MD, Miami Cardiac and Vascular Institute.
Recruitment status was:  Recruiting
First Posted : January 10, 2014
Last Update Posted : March 21, 2016
Sponsor:
Information provided by (Responsible Party):
Constantino Pena, MD, Miami Cardiac and Vascular Institute

Brief Summary:
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.

Condition or disease
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.


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-Enhanced Magnetic Resonance Angiography With the t-SLIP Technique
Study Start Date : April 2013
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2017

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.



Primary Outcome Measures :
  1. Degree of enhancement by evaluation of the Thoracic, Aortic, Renal, Iliac and Femoral Vasculature Images [ Time Frame: 2 Years ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All Patients Needing Thoracic, Aortic, Renal, Iliac and/or Femoral Vasculature MRIs
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02032940


Contacts
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Contact: Raul Herrera, MD 786-596-3505 raulh@baptisthealth.net
Contact: Constantino Pena, MD 786-596-5990 ConstantinoP@baptisthealth.net

Locations
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United States, Florida
Baptist Cardiac and Vascular Institute Recruiting
Miami, Florida, United States, 33176
Miami Cardiac and Vascular Institute Recruiting
Miami, Florida, United States, 33176
Contact: Raul Herrera, MD    786-596-5974    Raulh@baptisthealth.net   
Contact: Constantino Pena, MD    786-596-5990    constantinop@baptisthealth.net   
Miami Cardiac and Vascular Institute Recruiting
Miami, Florida, United States, 33176
Contact: Raul E Herrera, MD    786-596-3505    raulh@baptisthealth.net   
Contact: Constantino Pena, MD    786-596-53505    constantinop@baptisthealth.net   
Sponsors and Collaborators
Miami Cardiac and Vascular Institute
Investigators
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Principal Investigator: Constantino Pena, MD Baptist Cardiac and Vascular Institute

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Responsible Party: Constantino Pena, MD, Constantino Pena, MD. Medical Director of Vascular Imaging, Miami Cardiac and Vascular Institute
ClinicalTrials.gov Identifier: NCT02032940     History of Changes
Other Study ID Numbers: 2013-020
First Posted: January 10, 2014    Key Record Dates
Last Update Posted: March 21, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Constantino Pena, MD, Miami Cardiac and Vascular Institute:
MRI, Angiography, Pulse Sequence