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VAPORHCS/OHSU J: MRI and Devices

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03915015
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : October 6, 2020
Sponsor:
Information provided by (Responsible Party):
Charles Henrikson, MD, Oregon Health and Science University

Brief Summary:
This is a database study of clinically indicated MRIs on patients with permanent pacemakers and implantable cardioverter defibrillators.

Condition or disease Intervention/treatment Phase
MRI Diagnostic Test: MRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: VAPORHCS/OHSU J: Safety of Clinically Indicated Magnetic Resonance Imaging in Patients With Permanent Pacemakers (PPM) and Implanted Cardioverter Defibrillators (ICDs)
Actual Study Start Date : July 19, 2012
Estimated Primary Completion Date : December 31, 2030
Estimated Study Completion Date : December 31, 2030

Arm Intervention/treatment
the study
Patients with a PPM or ICD getting a clinically indicated MRI
Diagnostic Test: MRI
MRI




Primary Outcome Measures :
  1. MRI Safety during MRI scan in patients with PPMs/ICDs. [ Time Frame: During MRI scan. ]
    Percent of patients successfully completing MRI scan without complication per interrogation of their device and clinical assessment.

  2. MRI Safety following MRI scan in patients with PPMs/ICDs. [ Time Frame: 1-6 week follow up in device clinic ]
    Percent of patients successfully following up after MRI scan without complication per interrogation of their device and clinical assessment.



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Patients with an absolute clinical need for MR imaging and PPM (year 1996 model or later) or ICD's (year 2000 or later)

Exclusion Criteria:

  • Patients with pacemaker models before 1996 and ICD models before year 2000.
  • Pacemaker dependent patients with ICD.
  • Patients who weighing less than 80 lbs.
  • Patients who complete the MRI standard screening form and are deemed inappropriate for MRI for any reason
  • Pregnant patients will be excluded in their first trimester and will not get gadolinium at any time during their pregnancy
  • Patient with abandoned/capped leads or leads implanted <4 weeks unless the procedure is deemed critical by the referring physician and approved by the PI

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915015


Contacts
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Contact: Charles Henrikson, MD 503-494-7400 henrikso@ohsu.edu

Locations
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United States, Oregon
Oregon Health and Scince University Recruiting
Portland, Oregon, United States, 97239
Contact: Charles Henrikson, MD         
Portland Veterans Administration Medical Center Recruiting
Portland, Oregon, United States, 97239
Contact: Peter Jessel, MD         
Sponsors and Collaborators
Oregon Health and Science University
Investigators
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Principal Investigator: Charles Henrikson, MD Oregon Health and Science University
Publications:
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Responsible Party: Charles Henrikson, MD, Professor of Medicine, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT03915015    
Other Study ID Numbers: 8423
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes