Patient Registry Of Magnetic Resonance Imaging in Non-Approved DEvices

NCT03081364 | Completed

• 1 other identifier: 15-335
• Study Type: observational
• Target: 532
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Magnetic Field Exposure

Keywords

Cardiac Implanted Device

Outcome Measures

Primary Outcomes (8)

• Change in Device Function

  Change in lead impedance or sensing

  3 years

• Change in Thresholds of Pacing Lead

  Measured in mA

  3 years

• Dysrhythmias Noted During Scan

  Change in heart rhythm

  3 years

• Oxygen Saturation

  Percentage of change or no change

  3 years

• Change in heart rate

  Measured as beats per minute on single-lead heart monitor.

  3 years

• Patient Comments

  Real-time patient report via intercom during scan of chest symptoms such as burning or aching

  3 years

• Interference Between the Implanted Cardiac Electronic Device and MRI

  Measure any change in device battery voltage

  3 years

• Change in blood pressure

  Monitored with automatic blood pressure cuff

  3 years

Study Arms (1)

Outpatients

MRI; Critical Care Monitoring, Device Programming

Other: Initiate ACLS protocol if lethal arrythmia develops

Interventions

Initiate ACLS protocol if lethal arrythmia develops OTHER

Cardiac Rhythm Management

Outpatients

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

For all patients in whom a clinical MRI examination is felt to be important in the patients care, and in whom the potential benefits clearly outweigh the risks of an MRI exam as referred from various primary and/or subspecialty physicians.

You may qualify if:

• Anyone with a cardiac device

You may not qualify if:

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

Sponsors & Collaborators

• Saint Luke's Health System: lead

Related Publications (1)

• 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.

  PMID: 33778621 DERIVED

Study Officials

• Sanjaya K Gupta, MD

  St. Luke's Hospital, Kansas City, Missouri

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: March 16, 2017
• Study Start: September 1, 2015
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: June 12, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share