Magnetic Resonance Imaging (MRI) to Assess Radial Artery Compression and Arterial Perfusion While TR Band is Applied

NCT ID: NCT02478671

Last Updated: 2016-03-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2015-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Subjects' radial artery diameters and plethysmography waveforms will be recorded by MRI and pulse oxymetry at varying levels of radial artery compression by the Terumo TR Band.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In this study, the diameter of each subjects' radial artery will be measured using MRI imagery at varying degrees of radial artery compression by adjusting the amount of air injected into a Terumo TR Band. In addition, using pulse oxymetry, the perfusion waveform will be measured and recorded also while the subjects have a TR Band in place on their wrists.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Poor Peripheral Perfusion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TR Band

Each subject will have a Terumo TR Band applied to the wrist with MRI scans done at differing band pressure levels. The diameter of the radial artery will be measured at each level of band compression.

Group Type EXPERIMENTAL

TR Band

Intervention Type DEVICE

The radial artery will be compressed using a Terumo TR Band and artery diameter and perfusion will be measured

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TR Band

The radial artery will be compressed using a Terumo TR Band and artery diameter and perfusion will be measured

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Female or male adult (has reached the legal majority age).
2. Subject has provided his/her written informed consent to participate in the trial prior to any study -related procedure being conducted.

Exclusion Criteria

1. Abnormal result of either baseline Barbeau or reverse Barbeau tests.
2. Pregnant or breast feeding female.
3. Subject with contraindication to MRI
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medical University of South Carolina

OTHER

Sponsor Role collaborator

Terumo Medical Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marcelo Guimaraes, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TIS2015-002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Study of Blood Flow in Heart Muscle
NCT00001631 COMPLETED PHASE2