NCT01130896

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,509

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
7.1 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 26, 2010

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2015

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

December 12, 2018

Completed
Last Updated

May 13, 2021

Status Verified

April 1, 2021

Enrollment Period

11.7 years

First QC Date

May 20, 2010

Results QC Date

February 1, 2018

Last Update Submit

April 19, 2021

Conditions

Arrhythmias, Cardiac

Keywords

MRI, pacemakers, Defibrillator

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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 Outcomes (1)

  • Noise Artifacts as Assessed by the Number of Participants With a Greater Than a 50% Change in Lead Impedance

    Immediately post MRI (up to 2 hours)

Study Arms (1)

MRI and Cardiac Devices

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

Eligibility Criteria

Age9 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Implanted Cardiac Rhythm Management Devices

You may qualify if:

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

You may not qualify if:

  • Pacemaker dependent patients with ICD's
  • Patients with other contraindication to MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hospital, Blalcok 5 MRI

Baltimore, Maryland, 21205, United States

Location

Related Publications (4)

  • 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.

    PMID: 29281579RESULT

  • 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.

    PMID: 21969340RESULT

  • 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.

    PMID: 36716451DERIVED

  • 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.

    PMID: 32125255DERIVED

Related Links

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Henry Halperin, MD
Organization
Johns Hopkins University
nsaju1@jhmi.edu
410-955-2412

Study Officials

  • Henry R. Halperin, M.D.

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2010

First Posted

May 26, 2010

Study Start

May 1, 2003

Primary Completion

January 22, 2015

Study Completion

January 22, 2015

Last Updated

May 13, 2021

Results First Posted

December 12, 2018

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will share

Locations

US(1)