Myocardial Injury in Patients With Cardiac Implantable Electronic Devices Following Magnetic Resonance Imaging

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT04151953

Collaborator

(none)

105

Enrollment

Location

25.8

Actual Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Researchers are trying to determine if heart injury occurs in subjects with cardiac implantable electronic device (CIED), such as a pacemaker or implantable cardioverter defibrillator (ICD), who undergo a magnetic resonance imaging (MRI).

Condition or Disease	Intervention/Treatment	Phase
Magnetic Resonance Imaging (MRI)	Diagnostic Test: Blood sample collection

Detailed Description

With an aging population and growing indications for both MRI and CIEDs, it is estimated that patients with a CIED will have up to a 75% likelihood to meet some indication for MRI during their lifetime. MRI in patients with CIEDs has been increasingly shown to be a viable option in a variety of clinical circumstances under strict protocols and close monitoring. It is uncertain if MRI results in myocardial injury. Injury could occur due to heating of the lead(s) with myocardial heating and injury occurring at the lead tip.

A previous Mayo study published in 2016 showed no significant changes in cardiac troponin levels in the majority of patients with a CIED when MRI was performed. This study however was done using the older, less sensitive troponin assay. Unpublished data from the Mayo ED showed an increase in diagnosis of acute myocardial injury from 39% to 62% after implementation of the new hs-cTnT assay, reflecting its increased sensitivity. The previous Mayo study was also a retrospective study, and thus the data gathered was not as rigorously controlled as might be ideal.

Study Design

Study Type:

Observational

Actual Enrollment :

105 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Evaluation of Potential Myocardial Injury in Patients With Cardiac Implantable Electronic Devices Following Magnetic Resonance Imaging

Actual Study Start Date :

Oct 8, 2019

Actual Primary Completion Date :

Aug 3, 2020

Actual Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Subjects with cardiac implantable electronic device (CIED) Subjects with previously implanted cardiac implantable electronic device (CIED) who are undergoing an MRI Scan for clinically indicated, diagnostic purposes.	Diagnostic Test: Blood sample collection Blood sample collection for markers of myocardial injury

Arm

Intervention/Treatment

Subjects with cardiac implantable electronic device (CIED)

Subjects with previously implanted cardiac implantable electronic device (CIED) who are undergoing an MRI Scan for clinically indicated, diagnostic purposes.

Diagnostic Test: Blood sample collection

Blood sample collection for markers of myocardial injury

Outcome Measures

Primary Outcome Measures

Myocardial injury [Baseline, 6-24 hours post MRI]
Changes in high sensitivity cardiac troponin T (hs-cTnT) or troponin I (hs-cTnI) assay

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients who have CIED devices (whether conditional or unconditional, regardless of the type of device e.g. ICD, pacemakers, leadless pacemakers) who undergo MRI for any reason

Exclusion Criteria:

Patients under age 18
Patients with myocardial infarction, coronary artery bypass grafting or any invasive cardiac procedure in the previous six weeks
Pregnant patients
Patients who cannot provide informed consent because of cognitive dysfunction

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Allan S Jaffe, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Allan S. Jaffe, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT04151953

Other Study ID Numbers:

19-004286

First Posted:

Nov 5, 2019

Last Update Posted:

Jan 5, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Allan S. Jaffe, Principal Investigator, Mayo Clinic

Pacemaker

Implantable Cardioverter Defibrillator (ICD)

Cardiac implantable electronic device (CIED)

Study Results

No Results Posted as of Jan 5, 2022