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

NCT04151953 | Completed

• 1 other identifier: 19-004286
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

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).

Conditions

Magnetic Resonance Imaging (MRI)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Myocardial injury

  Changes in high sensitivity cardiac troponin T (hs-cTnT) or troponin I (hs-cTnI) assay

  Baseline, 6-24 hours post MRI

Study Arms (1)

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

Interventions

Blood sample collection DIAGNOSTIC_TEST

Blood sample collection for markers of myocardial injury

Subjects with cardiac implantable electronic device (CIED)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult males and females age 18 and above identified from the electronic medical record (EMR) calendar of patients with devices who are coming for a MRI

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum or plasma samples remaining after initial analysis will be frozen and stored at -80 degrees Celsius for 120 months (10 years). These samples may be used if there are new and more sensitive biomarkers of myocardial injury that become available.

Study Officials

• Allan S Jaffe, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 2, 2019
• First Posted: November 5, 2019
• Study Start: October 8, 2019
• Primary Completion: August 3, 2020
• Study Completion: December 1, 2021
• Last Updated: January 5, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)