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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04151953
Enrollment
105
Registered
2019-11-05
Start date
2019-10-08
Completion date
2021-12-01
Last updated
2022-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Magnetic Resonance Imaging (MRI)

Keywords

Pacemaker, Implantable Cardioverter Defibrillator (ICD), Cardiac implantable electronic device (CIED)

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 Unpublished data from the Mayo ED showed an increase in diagnosis of acute myocardial injury from 39% to 62% after implementation of the new hs-cTnT assay, reflecting its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

Interventions

DIAGNOSTIC_TESTBlood sample collection

Blood sample collection for markers of myocardial injury

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Myocardial injuryBaseline, 6-24 hours post MRIChanges in high sensitivity cardiac troponin T (hs-cTnT) or troponin I (hs-cTnI) assay

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026