Patient Registry Of Magnetic Resonance Imaging in Non-Approved DEvices (PROMeNADe)

The investigators are providing MRI in patients with non-MRI approved CIED's (Cardiac Implanted Electronic Devices)

Study Overview

• Status: Completed
• Conditions: Magnetic Field Exposure
• Intervention / Treatment: Other: Initiate ACLS protocol if lethal arrythmia develops

Detailed Description

At Saint Luke's Hospital, despite growing evidence to the contrary, there is extremely limited data and experience with performing MRIs on patient with abandoned and epicardial leads in patients with non-approved ICDs and PMs. There is a limited mechanism to discuss this issue with the patient, screen the patient and assess their device beforehand, monitor them during the MRI examination, keep track of pulse sequences used, assess their devices after (and if necessary, resume prior programming before any changes), and to maintain that experience. The objective of this study is to create a protocol for an MRI at the commonly used magnetic strength of 1.5 T in patients that do not have conditional pacemakers and/or defibrillators and have abandoned or epicardial leads and maintain a registry of participants, devices involved, MRI examinations and pulse sequences used, and to keep records of any follow up events.

• Study Type: Observational
• Enrollment (Actual): 532

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

For all patients in whom a clinical MRI examination is felt to be important in the patients care, and in whom the potential benefits clearly outweigh the risks of an MRI exam as referred from various primary and/or subspecialty physicians.

Description

Inclusion Criteria:

• Anyone with a cardiac device

Exclusion Criteria:

• Anyone who cannot consent for themselves or who don't have a durable power of attorney

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Outpatients; MRI; Critical Care Monitoring, Device Programming	Other: Initiate ACLS protocol if lethal arrythmia develops; Cardiac Rhythm Management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Device Function	Change in lead impedance or sensing	3 years
Change in Thresholds of Pacing Lead	Measured in mA	3 years
Dysrhythmias Noted During Scan	Change in heart rhythm	3 years
Oxygen Saturation	Percentage of change or no change	3 years
Change in heart rate	Measured as beats per minute on single-lead heart monitor.	3 years
Patient Comments	Real-time patient report via intercom during scan of chest symptoms such as burning or aching	3 years
Interference Between the Implanted Cardiac Electronic Device and MRI	Measure any change in device battery voltage	3 years
Change in blood pressure	Monitored with automatic blood pressure cuff	3 years

Collaborators and Investigators

• Sponsor: Saint Luke's Health System
• Investigators: Principal Investigator: Sanjaya K Gupta, MD, Saint Luke's Hospital of Kansas City

Publications and helpful links

General Publications

• Gupta SK, Ya'qoub L, Wimmer AP, Fisher S, Saeed IM. Safety and Clinical Impact of MRI in Patients with Non-MRI-conditional Cardiac Devices. Radiol Cardiothorac Imaging. 2020 Oct 22;2(5):e200086. doi: 10.1148/ryct.2020200086. eCollection 2020 Oct.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: January 4, 2017
• First Submitted That Met QC Criteria: March 10, 2017
• First Posted (Actual): March 16, 2017

Study Record Updates

• Last Update Posted (Actual): June 12, 2023
• Last Update Submitted That Met QC Criteria: June 8, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Cardiac Implanted Device
• Other Study ID Numbers: 15-335

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share the IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No