Clinically Indicated Magnetic Resonance Imaging in Patients With Cardiac Devices

NCT ID: NCT01130896

Last Updated: 2021-05-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1509 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-05-31

Study Completion Date

2015-01-22

Brief Summary

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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

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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.

Conditions

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Arrhythmias, Cardiac

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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MRI and Cardiac Devices

Clinically indicated MRI (all types) in patients with implanted pacemakers and ICD

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Henry R. Halperin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins Hospital, Blalcok 5 MRI

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 29281579 (View on PubMed)

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.

Reference Type RESULT
PMID: 21969340 (View on PubMed)

Ra J, Oberdier MT, Suzuki M, Vaidya D, Liu Y, Hansford R, McVeigh D, Weltin V, Tao S, Thiemann DR, Nazarian S, Halperin HR. Implantable Defibrillator System Shock Function, Mortality, and Cause of Death After Magnetic Resonance Imaging. Ann Intern Med. 2023 Mar;176(3):289-297. doi: 10.7326/M22-2653. Epub 2023 Jan 31.

Reference Type DERIVED
PMID: 36716451 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32125255 (View on PubMed)

Related Links

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Other Identifiers

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RPN03-08-12-11

Identifier Type: -

Identifier Source: org_study_id

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