Study Evaluating the Use of MRI on CMS Patients (PM/ICD)

Prospective Observational Study Evaluating the Use of MRI on CMS Beneficiaries With Non-Conditional Pacemakers and/or Implantable Cardioverter Defibrillators

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pacemaker; Implantable Cardioverter Defibrillators
• Intervention / Treatment: Other: 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.

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with pacemakers and/or implantable cardioverter defibrillators (ICD) referred for an outpatient Magnetic Resonance Imaging (MRI) procedure.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician decision making	The primary measure of this study is physician decision making. Referring physicians will be asked about the effect of the MRI clinical management strategy, planning of treatments and interventions, as well as if/how the MRI results prevented other diagnostic studies or interventions, and other exposures (such as to ionizing radiation or iodinated contrast from CT scans). Analysis will be tabulation of how scan would change treatment or prognosis and what would be done if MR not available (based upon referring physician response on the screening form, physician and how the physicians believe that having the MRI will impact the treatment and quality of life by completing the QOL form.	4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Adverse events related to the MRI scan will be recorded and reviewed. AE's will be reviewed based on the criteria set forth in the protocol. AEs will be documented on an AE form and AE log and then entered into a redcap database.	4 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients will be asked how the MRI affected their quality of life, concerning	Patients will complete a Quality of Life form identifying how the MRI affected their quality of life, concerning both the MRI procedure itself and the fact that the MRI could be performed and diagnostic information about their conditions obtained.	4 years

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Study Chair: Mitchell Schnall, MD, PhD, University of Pennsylvania; Principal Investigator: Harold Litt, MD, PhD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2015
• Primary Completion (Actual): December 1, 2019
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: December 8, 2014
• First Submitted That Met QC Criteria: July 28, 2015
• First Posted (Estimate): July 31, 2015

Study Record Updates

• Last Update Posted (Actual): March 13, 2023
• Last Update Submitted That Met QC Criteria: March 10, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: implantable cardioverter defibrillator; non-conditional pacemakers
• Other Study ID Numbers: 821487