NCT02032940

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2013

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 10, 2014

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

April 3, 2023

Status Verified

March 1, 2023

Enrollment Period

7 years

First QC Date

January 8, 2014

Last Update Submit

March 29, 2023

Conditions

Focus of Study is MRI

Keywords

MRI, Angiography, Pulse Sequence

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Patients that can not undergo standard MRA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Baptist Cardiac and Vascular Institute

Miami, Florida, 33176, United States

Location

Miami Cardiac and Vascular Institute

Miami, Florida, 33176, United States

Location

Study Officials

  • Constantino Pena, MD

    Baptist Cardiac and Vascular Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Constantino Pena, MD. Medical Director of Vascular Imaging

Study Record Dates

First Submitted

January 8, 2014

First Posted

January 10, 2014

Study Start

April 1, 2013

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

April 3, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)