Study Evaluating the Use of MRI on CMS Patients

NCT02513056 | Completed

• 1 other identifier: 821487
• Study Type: observational
• Target: 872
• Locations: 1 country
• Sites: 1

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.

Conditions

Pacemaker; Implantable Cardioverter Defibrillators

Keywords

non-conditional pacemakers; implantable cardioverter defibrillator

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adverse Events

  4 years

Other Outcomes (1)

• Patients will be asked how the MRI affected their quality of life, concerning

  4 years

Interventions

MRI OTHER

MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients are at least 18 years of age
• Patients have a medically/clinically indicated need for an MRI as an outpatient
• Patients with a non-MRI conditional pacemaker and/or ICD implanted after the year 2000
• Patients are CMS beneficiaries
• Patients are willing and able to sign consent and HIPAA authorization or is authorized to sign consent for subject.

You may not qualify if:

• Other contraindications to MRI
• Pacemaker or ICD implanted prior to the year 2000
• Patient is unwilling/unable to sign consent and HIPAA authorization
• Leads and/or generator implanted within 6 weeks of the proposed MRI

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Study Officials

• Mitchell Schnall, MD, PhD

  University of Pennsylvania

  STUDY CHAIR

• Harold Litt, MD, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: July 31, 2015
• Study Start: August 17, 2015
• Primary Completion: December 1, 2019
• Study Completion: February 1, 2022
• Last Updated: May 14, 2024

Record last verified: 2024-05

Locations

US (1)