Patient Registry Of Magnetic Resonance Imaging in Non-Approved DEvices

NCT ID: NCT03081364

Last Updated: 2023-06-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 532 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2022-09-30

Brief Summary

The investigators are providing MRI in patients with non-MRI approved CIED's (Cardiac Implanted Electronic Devices)

Detailed Description

At Saint Luke's Hospital, despite growing evidence to the contrary, there is extremely limited data and experience with performing MRIs on patient with abandoned and epicardial leads in patients with non-approved ICDs and PMs. There is a limited mechanism to discuss this issue with the patient, screen the patient and assess their device beforehand, monitor them during the MRI examination, keep track of pulse sequences used, assess their devices after (and if necessary, resume prior programming before any changes), and to maintain that experience. The objective of this study is to create a protocol for an MRI at the commonly used magnetic strength of 1.5 T in patients that do not have conditional pacemakers and/or defibrillators and have abandoned or epicardial leads and maintain a registry of participants, devices involved, MRI examinations and pulse sequences used, and to keep records of any follow up events.

Conditions

Magnetic Field Exposure

Study Design

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

Study Groups

Outpatients

MRI; Critical Care Monitoring, Device Programming

Initiate ACLS protocol if lethal arrythmia develops

Intervention Type: OTHER

Cardiac Rhythm Management

Interventions

Initiate ACLS protocol if lethal arrythmia develops

Cardiac Rhythm Management

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Anyone with a cardiac device

Exclusion Criteria

• Anyone who cannot consent for themselves or who don't have a durable power of attorney

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saint Luke's Health System

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sanjaya K Gupta, MD

Role: PRINCIPAL_INVESTIGATOR

St. Luke's Hospital, Kansas City, Missouri

References

Gupta SK, Ya'qoub L, Wimmer AP, Fisher S, Saeed IM. Safety and Clinical Impact of MRI in Patients with Non-MRI-conditional Cardiac Devices. Radiol Cardiothorac Imaging. 2020 Oct 22;2(5):e200086. doi: 10.1148/ryct.2020200086. eCollection 2020 Oct.

Reference Type: DERIVED

PMID: 33778621 (View on PubMed)

Other Identifiers

15-335

Identifier Type: -

Identifier Source: org_study_id