Refinement and Assessment of New MRI Technologies for Cardiovascular Exams Using the Phillips CMR Patch

March 19, 2024 updated by: Prachi P Agarwal, M.D., University of Michigan

Refinement and Assessment of New MRI Technologies for Cardiovascular Exams Using the Phillips Cardiac Magnetic Resonance (CMR) Patch

This study is being done to improve image quality and provide the collaborator with feedback on wide band imaging in patients with cardiac implantable electronic devices (CIED).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

292

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Michigan Medicine - University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: have a clinically ordered cardiac MRI exam at University of Michigan -

Exclusion Criteria: pregnant; contraindication to MRI

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CMR in CIED
Patients at Michigan Medicine who come in for cardiac imaging procedures and who have CIEDs.
Device: CMR patch
The Cardiac Magnetic Resonance (MR) patch is a sequence modification for enhancing the images in patients with devices (CIED) for assessing heart muscle scar. The Philips tested patch supports multiple cardiac MR imaging enhancements compiled from several individual patches generated by multiple Philips MR research collaborators for use on 1.5 Tesla Philips scanners.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scan speed:
Time Frame: Up to an hour
Scan speed is time required to set-up and run the new technique relative to the standard method.
Up to an hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

Philips Health Care

Investigators

  • Principal Investigator: Prachi Agarwal, MD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2021

Primary Completion (Actual)

June 29, 2023

Study Completion (Actual)

June 29, 2023

Study Registration Dates

First Submitted

March 19, 2024

First Submitted That Met QC Criteria

March 19, 2024

First Posted (Actual)

March 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00176904

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiomyopathies

Clinical Trials on CMR patch

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe