Myocardial Injury in Patients With Cardiac Implantable Electronic Devices Following Magnetic Resonance Imaging
- Conditions
- Magnetic Resonance Imaging (MRI)
- Interventions
- Diagnostic Test: Blood sample collection
- Registration Number
- NCT04151953
- Lead Sponsor
- Mayo Clinic
- 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 Unpublished data from the Mayo ED showed an increase in diagnosis of acute myocardial injury from 39% to 62% after implementation of the new hs-cTnT assay, reflecting its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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 105
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Subjects with cardiac implantable electronic device (CIED) Blood sample collection Subjects with previously implanted cardiac implantable electronic device (CIED) who are undergoing an MRI Scan for clinically indicated, diagnostic purposes.
- Primary Outcome Measures
Name Time Method Myocardial injury Baseline, 6-24 hours post MRI Changes in high sensitivity cardiac troponin T (hs-cTnT) or troponin I (hs-cTnI) assay
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States