Cardiomyopathies
Conditions
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).
Interventions
DEVICECMR 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.
Sponsors
Philips Health Care
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
have a clinically ordered cardiac MRI exam at University of Michigan -
Exclusion criteria
pregnant; contraindication to MRI \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Scan Speed | During the procedure (up to 90 minutes) | Scan speed is time required to set-up and run the new technique relative to the standard method. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CMR in CIED Patients at Michigan Medicine who come in for cardiac imaging procedures and who have CIEDs.
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. | 292 |
| Total | 292 |
Baseline characteristics
| Characteristic | CMR in CIED | — |
|---|---|---|
| Age, Customized >18 years | 292 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 292 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 292 |
| other Total, other adverse events | 0 / 292 |
| serious Total, serious adverse events | 0 / 292 |
Outcome results
Primary
Scan Speed
Scan speed is time required to set-up and run the new technique relative to the standard method.
Time frame: During the procedure (up to 90 minutes)
Population: Scan speed was originally intended to be a form of feedback to the collaborator. Because of changes in standard practice and the patch sequence becoming mainstream, data was not collected for analysis.