Clinically Indicated Magnetic Resonance Imaging in Patients With Cardiac Devices

Arrhythmias, Cardiac Clinical Trial

Official title:

Clinically Indicated Magnetic Resonance Imaging of Patients With Permanent Pacemakers (PPM) and Implantable Defibrillators (ICD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01130896
• Other study ID #: RPN03-08-12-11
• Status: Completed
• Start date: May 2003
• Est. completion date: January 22, 2015

Study information

• Verified date: April 2021
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Patients with implanted cardiac devices who meet appropriate entrance criteria undergo clinically indicated Magnetic Resonance (MR) Imaging Studies using an established safety protocol.

Description:

This prospective cohort study to use an established MRI device safety protocol to decrease the risk of clinically indicated MR imaging in patients with implantable cardiac devices. All devices will undergo a complete interrogation and testing of thresholds, sensing, battery voltage and impedances prior to and following imaging. Pre-MRI, devices will be programmed to setting that will ensure MRI safety. During imaging, patients will blood pressure, heart rate and O2 sat level will be monitored continuously.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1509
• Est. completion date: January 22, 2015
• Est. primary completion date: January 22, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years and older

Eligibility

Inclusion Criteria:

• Patients with an emergent or absolute need for MR imaging and PPM or certain ICD's

Exclusion Criteria:

• Pacemaker dependent patients with ICD's

• Patients with other contraindication to MRI

Related Conditions & MeSH terms

• Arrhythmias, Cardiac

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital, Blalcok 5 MRI	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Nazarian S, Hansford R, Rahsepar AA, Weltin V, McVeigh D, Gucuk Ipek E, Kwan A, Berger RD, Calkins H, Lardo AC, Kraut MA, Kamel IR, Zimmerman SL, Halperin HR. Safety of Magnetic Resonance Imaging in Patients with Cardiac Devices. N Engl J Med. 2017 Dec 28 — View Citation

Nazarian S, Hansford R, Roguin A, Goldsher D, Zviman MM, Lardo AC, Caffo BS, Frick KD, Kraut MA, Kamel IR, Calkins H, Berger RD, Bluemke DA, Halperin HR. A prospective evaluation of a protocol for magnetic resonance imaging of patients with implanted card — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device Malfunction	Number of patients with change in device testing defined as a change in any of the following (impedance, battery life, p and r wave sensing and atrial and ventricular capture thresholds) not to exceed 50 percent from baseline	immediately post MRI (up to 2 hours) and long-term follow-up (up to 6 months)
Primary	Patient Safety	Number of patients with change in vital signs including blood pressure, heart rate and pulse oximetry not to exceed 10 percent from baseline lead impedances as well as patient reports of any discomfort related to MRI)	assessed during MRI and immediate post MRI (up to 2 hours)
Secondary	Noise Artifacts as Assessed by the Number of Participants With a Greater Than a 50% Change in Lead Impedance	We will evaluate whether or not the artifacts produced are significant enough to prevent diagnostic interpretation of images	Immediately post MRI (up to 2 hours)

External Links

•   PubMed Citation #1
•   PubMed Citation #2