Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-03-01 @ 12:05 PM
Study NCT ID:
NCT02513056
Status:
COMPLETED
Last Update Posted:
2024-05-14
First Post:
2014-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating the Use of MRI on CMS Patients
Sponsor:
University of Pennsylvania
Organization:
Study Overview
Official Title:
Prospective Observational Study Evaluating the Use of MRI on CMS Beneficiaries With Non-Conditional Pacemakers and/or Implantable Cardioverter Defibrillators
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PM/ICD
Brief Summary:
The overall objective of this protocol is to evaluate the safety and utility of diagnostic MRI in Center for Medicare and Medicaid Services (CMS) beneficiaries with pacemakers and Implantable Cardioverter Defibrillators (ICD) and clinical need for MRI.
Detailed Description:
A referring physician will request an outpatient MRI in an implanted device patient through an order placed in the electronic ordering system, over the telephone to the MRI scheduling office, or by directly contacting a radiologist or MRI technologist. Upon receiving such a request, the referring physician will be sent a copy of the attached screening form, which is used for all implanted device patients. The form includes instructions for obtaining approval for the study and space for documenting ordering physician, study indication, and information about the patient's implanted device (if their device is not followed by a UPHS physician). For CMS beneficiaries, an addition to the form will discuss the clinical trial and ask the referring physician how the results of the MRI will change patient treatment or prognosis and what would be done were an MRI not available. The approval of an attending radiologist in the radiology section that will be interpreting the study (e.g. neuroradiology for brain MRI, cardiovascular imaging for cardiac MRI) is required.
Once the patient is deemed eligible and consented, the study staff will enter the patient into the registry as well as register them onto the trial through PennChart.
Once the patient is deemed eligible and consented, the study staff will enter the patient into the registry as well as register them onto the trial through PennChart.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: