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

NCT ID: NCT04151953

Last Updated: 2022-01-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 105 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-08
• Study Completion Date: 2021-12-01

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).

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 Unpublished data from the Mayo ED showed an increase in diagnosis of acute myocardial injury from 39% to 62% after implementation of the new hs-cTnT assay, reflecting its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.

Conditions

Magnetic Resonance Imaging (MRI)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Blood sample collection

Intervention Type: DIAGNOSTIC_TEST

Blood sample collection for markers of myocardial injury

Interventions

Blood sample collection

Blood sample collection for markers of myocardial injury

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Allan S. Jaffe

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Allan S Jaffe, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

19-004286

Identifier Type: -

Identifier Source: org_study_id