Study Evaluating the Use of MRI on CMS Patients

NCT ID: NCT02513056

Last Updated: 2024-05-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 872 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-08-17
• Study Completion Date: 2022-02-01

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.

Conditions

Pacemaker; Implantable Cardioverter Defibrillators

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Interventions

MRI

MRI

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Patients are at least 18 years of age

2. Patients have a medically/clinically indicated need for an MRI as an outpatient

3. Patients with a non-MRI conditional pacemaker and/or ICD implanted after the year 2000

4. Patients are CMS beneficiaries

5. Patients are willing and able to sign consent and HIPAA authorization or is authorized to sign consent for subject.

Exclusion Criteria

1. Other contraindications to MRI

2. Pacemaker or ICD implanted prior to the year 2000

3. Patient is unwilling/unable to sign consent and HIPAA authorization

4. Leads and/or generator implanted within 6 weeks of the proposed MRI

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mitchell Schnall, MD, PhD

Role: STUDY_CHAIR

University of Pennsylvania

Harold Litt, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

821487

Identifier Type: -

Identifier Source: org_study_id