Assessment Of MRI In Patients With Implanted Cardiac Devices (MRIPACER)

The research goal is to continue to add to the extensive body of peer-reviewed evidence that demonstrates MRI may be safely performed in patients with cIEDs, after they have been evaluated and cleared by cardiology. This study will allow the researchers to collect data from the facilities ongoing clinical practice regarding the number and types of any adverse clinical reactions, and also to document any changes in the implanted cardiac device that may have occurred during the MRI scan. The researchers will also be assessing the results of the MRI and how the imaging findings impact patient care and the clinical outcome of the patient. This data will then be presented to the FDA and the Centers for Medicare and Medicaid Services to further influence federal guidelines and payment structures.

Study Overview

• Status: Unknown
• Conditions: Arrhythmias, Cardiac

Detailed Description

Cardiac implantable electronic devices (cIEDs) generally refer to implanted pacemakers and defibrillators for patients with cardiac disorders affecting their heart rhythm. Previously, cIEDs have been regarded as a contraindication to magnetic resonance imaging (MRI) scans, with concerns that the magnetic fields of the MRI may cause problems with the patient's cIED. However, this is a major healthcare issue, as approximately 50-75% of patients with implanted cIEDs are expected to need a future MRI as part of their clinical care. The inability to get such a test may negatively impact the ability to diagnose and treat future diseases.

However, many of the initial concerns regarding the capability of performing MRI in patients with cIED have likely been overstated. There is peer-reviewed literature dating back to the 1990s regarding the ability to safely perform MRI in patients with cIEDs, if certain protocols are followed regarding patient selection and monitoring. In 2011, Nazarian et al from Johns Hopkins University published a study on 438 patients with cIED that received MRI. There were no adverse clinical effects from this study. In fact, the American College of Radiology updated it's guidance document for Safe MR Practices, and cIEDs are no longer listed as a relative contraindication to obtaining an MRI. However, the presence of cIEDs are still regarded as a relative contraindication to performing MRI at some centers. In addition, performance of MRI in the setting of cIED is denied by the Centers for Medicare and Medicaid Services. Continued accrual of data regarding the safety of performing MRI in patients with cIEDs is needed, including outcomes studies that document the clinical impact of improved diagnostics provided by the MRI on patient care.

• Study Type: Observational
• Enrollment (Anticipated): 1500

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • Recruiting
      • Banner University Medical Center-Tucson
      • Contact: Bobby Kalb, MD; Phone Number: 520-626-9444; Email: bkalb@radiology.arizona.edu
      • Contact: Shannon Urbina, RPA; Phone Number: 520-626-7500; Email: shannonu@email.arizona.edu

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

All patients that require an MRI as part of the normal course of their medical care that also have a cIED and are candidates for MRI .

Description

Inclusion Criteria:

• All patients that require an MRI as part of the normal course of their medical care that also have a cIED and are candidates for MRI .

Exclusion Criteria:

• patient does not require an MRI for their medical care
• patient does not have a cIED
• patient has not been seen or approved by cardiology to be a candidate for MRI
• patients under the age of 18
• pregnant patients
• prisoners

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of MRI, adverse clinical events	collect safety data	immediately post MRI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact to Patient Care	assess the results of the MRI and how the imaging findings impact patient care	6 months
Morbidity, Number of hospitalizations	collected from medical record	6 months
Mortality, outcome of death	collected from medical records and phone calls	6 months

Collaborators and Investigators

• Sponsor: University of Arizona
• Investigators: Principal Investigator: Bobby Kalb, MD, University of Arizona

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2017
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): October 1, 2019

Study Registration Dates

• First Submitted: May 26, 2016
• First Submitted That Met QC Criteria: June 23, 2016
• First Posted (Estimate): June 28, 2016

Study Record Updates

• Last Update Posted (Actual): October 25, 2017
• Last Update Submitted That Met QC Criteria: October 24, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: 1605560370

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO