MRI scans for patients with pacemakers and defibrillators
VAPORHCS/OHSU J: Safety of Clinically Indicated Magnetic Resonance Imaging in Patients With Permanent Pacemakers (PPM) and Implanted Cardioverter Defibrillators (ICDs)
NA · Oregon Health and Science University · NCT03915015
This study is testing whether it's safe to perform MRI scans on patients with pacemakers and defibrillators to help them get the imaging they need.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 10000 (estimated) |
| Ages | 9 Years to 99 Years |
| Sex | All |
| Sponsor | Oregon Health and Science University (other) |
| Locations | 2 sites (Portland, Oregon and 1 other locations) |
| Trial ID | NCT03915015 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety of performing MRI scans on patients who have permanent pacemakers and implantable cardioverter defibrillators (ICDs). It aims to include 1,000 patients at Oregon Health and Science University (OHSU) who have a clinical need for MRI, while adhering to strict safety protocols. The study hypothesizes that with appropriate precautions, MRIs can be safely conducted in these patients, addressing a significant gap in care where many are currently denied necessary imaging. The research will assess the types of devices and leads present in participants to ensure safety during the procedure.
Who should consider this trial
Good fit: Ideal candidates are patients with a clinical need for MRI who have pacemakers from 1996 or later and ICDs from 2000 or later.
Not a fit: Patients with older pacemaker or ICD models, those who are pacemaker dependent, or those with certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could allow thousands of patients with implanted devices to receive necessary MRI scans, improving their diagnostic and treatment options.
How similar studies have performed: Previous studies, including those from Johns Hopkins, have shown that MRIs can be safely performed on patients with similar devices when proper precautions are taken.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Portland, Oregon and 1 other locations
- Oregon Health and Scince University — Portland, Oregon, United States (RECRUITING)
- Portland Veterans Administration Medical Center — Portland, Oregon, United States (RECRUITING)
Study contacts
- Principal investigator: Charles Henrikson, MD — Oregon Health and Science University
- Study coordinator: Charles Henrikson, MD
- Email: henrikso@ohsu.edu
- Phone: 503-494-7400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: MRI