Clinical trial NCT01130896: Clinically Indicated Magnetic Resonance Imaging in Patients With Cardiac Devices
Official title: Clinically Indicated Magnetic Resonance Imaging of Patients With Permanent Pacemakers (PPM) and Implantable Defibrillators (ICD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arrhythmias, Cardiac
Keywords: MRI, pacemakers, Defibrillator
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2010-05-26
Enrollment: 1509
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Implanted Cardiac Rhythm Management Devices

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.

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.

Eligibility 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

Primary outcomes:
measure: Device Malfunction
timeFrame: immediately post MRI (up to 2 hours) and long-term follow-up (up to 6 months)
measure: Patient Safety
timeFrame: assessed during MRI and immediate post MRI (up to 2 hours)
Secondary outcomes:
measure: Noise Artifacts as Assessed by the Number of Participants With a Greater Than a 50% Change in Lead Impedance
timeFrame: Immediately post MRI (up to 2 hours)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital, Blalcok 5 MRI
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Henry R. Halperin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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 cardiac devices. Ann Intern Med. 2011 Oct 4;155(7):415-24. doi: 10.7326/0003-4819-155-7-201110040-00004.
citation: 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.