NCT04151953

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 105 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 Unpublished data from the Mayo ED showed an increase in diagnosis of acute myocardial injury from 39% to 62% after implementation of the new hs-cTnT assay, reflecting its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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Blood sample collection	Blood sample collection for markers of myocardial injury

Timeline

• Start date: 2019-10-08
• Primary completion: 2020-08-03
• Completion: 2021-12-01
• First posted: 2019-11-05
• Last updated: 2022-01-05

Locations

1 site across 1 country: United States