CardiomyopathiesNCT06331507

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

A study testing CMR patch in people with Cardiomyopathies, run by University of Michigan at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cardiomyopathies
What is being tested?: CMR patch
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 292 participants
Where: 1 siteUnited States
Study dates: 2 Sep 2021to 29 Jun 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

Trial locations and contacts

1 site in 1 country.

United States1 site

Michigan Medicine - University of Michigan
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Official title: 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).

Conditions: Cardiomyopathies
Being tested: CMR patch
Medical subject headings: Cardiomyopathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT06331507
Study group	Role	What they receive
CMR in CIED	Experimental	Patients at Michigan Medicine who come in for cardiac imaging procedures and who have CIEDs. Receives: Device: CMR patch

What is being measured

The primary outcome is the main question the study is designed to answer.

Scan Speed
Scan speed is time required to set-up and run the new technique relative to the standard method.
Measured: During the procedure (up to 90 minutes)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Sep 202129 Jun 2023

First posted26 Mar 2024
Study start2 Sep 2021
Primary completion29 Jun 2023
Study completion29 Jun 2023

Why it stopped: Principal Investigator choice

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for CardiomyopathiesStudies of the same condition, open and under way.
More trials run by University of MichiganThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 292 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06331507
Sponsor's protocol ID: HUM00176904
Status last verified: Jul 2024
First submitted: 19 Mar 2024
Last updated: 17 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
A Retrospective Observational Study of Epidemiology and Outcomes in Transthyretin Amyloid Cardiomyopathy in Germany
ATTR-CM (Transthyretin Amyloid Cardiomyopathy)
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction

All Cardiomyopathies trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Refinement and Assessment of New MRI Technologies for Cardiovascular Exams Using the Phillips Cardiac Magnetic Resonance (CMR) Patch
ClinicalTrials.gov ID: NCT06331507
Acronym / sponsor ID: HUM00176904
Conditions: Cardiomyopathies
Study type: Interventional
Recruitment status: TerminatedReason stopped: Principal Investigator choice
Enrolment: 292 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Collaborators: Philips Health Care
Study start: 2 Sep 2021 (actual)
Primary completion: 29 Jun 2023 (actual)
Study completion: 29 Jun 2023 (actual)
First posted: 26 Mar 2024 (actual)
Results: Posted 17 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
CMR in CIED	Experimental	Device: CMR patchPatients at Michigan Medicine who come in for cardiac imaging procedures and who have CIEDs.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (1 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CMR patchThe 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.	Device	CMR in CIED

Primary outcome

Scan Speed
Time frame: 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.

Results and safety

Results posted to the registry on 17 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CMR in CIED	292	292

Primary outcome: Scan Speed

Time frame: During the procedure (up to 90 minutes)

Population analysed: 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.

Adverse events

Time frame: During procedure (up to 90 minutes). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CMR in CIED	0 of 292 (0%)	0 of 292 (0%)	0 of 292

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Cardiomyopathies

RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
A Retrospective Observational Study of Epidemiology and Outcomes in Transthyretin Amyloid Cardiomyopathy in Germany
ATTR-CM (Transthyretin Amyloid Cardiomyopathy)
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Prachi Agarwal, MD principal investigator

University of Michigan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CMR patch in people with Cardiomyopathies, run by University of Michigan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Scan Speed (time frame: During the procedure (up to 90 minutes)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06331507.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.