Clinically Indicated Magnetic Resonance Imaging in Patients With Cardiac Devices

• ClinicalTrials.gov Identifier: NCT01130896
• Recruitment Status: Completed
• First Posted: May 26, 2010
• Results First Posted: December 12, 2018
• Last Update Posted: May 13, 2021
• Sponsor: Johns Hopkins University
• Information provided by (Responsible Party): Johns Hopkins University

Study Description

Brief Summary:

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

Condition or disease
Arrhythmias, Cardiac

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 1509 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Clinically Indicated Magnetic Resonance Imaging of Patients With Permanent Pacemakers (PPM) and Implantable Defibrillators (ICD)
• Actual Study Start Date: May 2003
• Actual Primary Completion Date: January 22, 2015
• Actual Study Completion Date: January 22, 2015

Groups and Cohorts

Group/Cohort
MRI and Cardiac Devices; Clinically indicated MRI (all types) in patients with implanted pacemakers and ICD

Outcome Measures

Primary Outcome Measures :

1. Device Malfunction [ Time Frame: immediately post MRI (up to 2 hours) and long-term follow-up (up to 6 months) ]
   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
2. Patient Safety [ Time Frame: assessed during MRI and immediate post MRI (up to 2 hours) ]
   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)

Secondary Outcome Measures :

1. Noise Artifacts as Assessed by the Number of Participants With a Greater Than a 50% Change in Lead Impedance [ Time Frame: Immediately post MRI (up to 2 hours) ]
   We will evaluate whether or not the artifacts produced are significant enough to prevent diagnostic interpretation of images

Eligibility Criteria

• Ages Eligible for Study: 9 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients with Implanted Cardiac Rhythm Management Devices

Criteria

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

Contacts and Locations

Locations

United States, Maryland

Johns Hopkins Hospital, Blalcok 5 MRI

Baltimore, Maryland, United States, 21205

Sponsors and Collaborators

Johns Hopkins University

Investigators

• Principal Investigator: Henry R. Halperin, M.D.; Johns Hopkins University

More Information

Additional Information:

PubMed Citation #1 

PubMed Citation #2 

Publications of Results:

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;377(26):2555-2564. doi: 10.1056/NEJMoa1604267.

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 cardiac devices. Ann Intern Med. 2011 Oct 4;155(7):415-24. doi: 10.7326/0003-4819-155-7-201110040-00004.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Rahsepar AA, Zimmerman SL, Hansford R, Guttman MA, Castro V, McVeigh D, Kirsch JE, Halperin HR, Nazarian S. The Relationship between MRI Radiofrequency Energy and Function of Nonconditional Implanted Cardiac Devices: A Prospective Evaluation. Radiology. 2020 May;295(2):307-313. doi: 10.1148/radiol.2020191132. Epub 2020 Mar 3.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT01130896
• Other Study ID Numbers: RPN03-08-12-11
• First Posted: May 26, 2010
• Results First Posted: December 12, 2018
• Last Update Posted: May 13, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

Keywords provided by Johns Hopkins University:

MRI, pacemakers, Defibrillator

Additional relevant MeSH terms:

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes