NCT06331507

Brief Summary

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).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
292

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

September 2, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 26, 2024

Completed
4 months until next milestone

Results Posted

Study results publicly available

July 17, 2024

Completed
Last Updated

July 17, 2024

Status Verified

July 1, 2024

Enrollment Period

1.8 years

First QC Date

March 19, 2024

Results QC Date

June 10, 2024

Last Update Submit

July 3, 2024

Conditions

Cardiomyopathies

Outcome Measures

Primary Outcomes (1)

  • Scan Speed

    Scan speed is time required to set-up and run the new technique relative to the standard method.

    During the procedure (up to 90 minutes)

Study Arms (1)

CMR in CIED

EXPERIMENTAL

Patients at Michigan Medicine who come in for cardiac imaging procedures and who have CIEDs.

Device: CMR patch

Interventions

CMR patchDEVICE

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.

CMR in CIED

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michigan Medicine - University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Prachi Agarwal
Organization
University of Michigan
prachia@med.umich.edu
734-232-5132

Study Officials

  • Prachi Agarwal, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 19, 2024

First Posted

March 26, 2024

Study Start

September 2, 2021

Primary Completion

June 29, 2023

Study Completion

June 29, 2023

Last Updated

July 17, 2024

Results First Posted

July 17, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)