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Procedure

MRI Safety for Pacemaker and Defibrillator Patients

N/A

Waitlist Available

Led By Henry R Halperin, MD/MA

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients implanted an ICD or pacemaker who have a clinical need for MR imaging

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 to 6 weeks

Awards & highlights

Study Summary

This trial is testing whether or not it is safe to get an MRI if you have a pacemaker or defibrillator, when in the past it was thought to be unsafe. They will be including 1700 people to see if there are any problems.

Who is the study for?

This trial is for patients with implanted pacemakers or defibrillators who need an MRI scan. Participants must meet standard MRI safety criteria, but unlike previous studies, they won't go through extra vetting because of their devices.Check my eligibility

What is being tested?

The study tests the safety of performing MRI scans on patients with certain heart devices without prior detailed device checks. It's a large study involving 1,700 participants to see if MRIs can be done safely under these new conditions.See study design

What are the potential side effects?

While not drug-related, potential side effects may include heating around the device area during the MRI, device malfunction or movement due to magnetic fields, and changes in device settings.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have an ICD or pacemaker and need an MRI.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 to 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 to 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 to 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Medical Devices

Secondary outcome measures

chronic patient safety and device malfunction

Trial Design

1Treatment groups

Experimental Treatment

Group I: Device: MRI no pre-screenExperimental Treatment1 Intervention

Clinically Indicated MRI will be done in patients with cardiac devices (pacemakers and defibrillators). Patients will not be pre-screened prior to hospital visit.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Yale UniversityOTHER

1,848 Previous Clinical Trials

2,734,118 Total Patients Enrolled

Johns Hopkins UniversityLead Sponsor

2,260 Previous Clinical Trials

14,817,080 Total Patients Enrolled

Henry R Halperin, MD/MAPrincipal InvestigatorJohns Hopkins University

Media Library

MRI (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT02888353 — N/A

Magnetic Resonance Imaging (MRI) Research Study Groups: Device: MRI no pre-screen

Magnetic Resonance Imaging (MRI) Clinical Trial 2023: MRI Highlights & Side Effects. Trial Name: NCT02888353 — N/A

MRI (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02888353 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are geriatric patients being considered for enrollment in this clinical trial?

"Patients between the ages of 9 and 100 are qualified to enter this clinical trial. There is also a separate set of trials available for minors and elderly individuals who fall outside that range."

Answered by AI

Who has the requisite qualifications to take part in this research project?

"This clinical study has the capacity to admit 3700 people of various ages from 9 to 100, all equipped with an MRI device. Most importantly, participants must have already implanted either an ICD or a pacemaker and be in need of Magnetic Resonance Imaging (MRI)."

Answered by AI

Are there any vacancies open for participants in this investigation?

"Clinicaltrials.gov documents suggest that this medical study is no longer recruiting participants, with the initial posting of the trial taking place on December 1st 2015 and last update occurring on December 10th 2021. Nevertheless, there are still other trials actively seeking volunteers at present."

Answered by AI

Recent research and studies

New England Journal of MedicineJournal

Safety of Magnetic Resonance Imaging in Patients with Cardiac Devices

Nazarian, Saman, Rozann Hansford, Amir A. Rahsepar, Valeria Weltin, Diana McVeigh, Esra Gucuk Ipek, Alan Kwan, et al.. 2017. “Safety of Magnetic Resonance Imaging in Patients with Cardiac Devices”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1604267.

clinicaltrials.govStudy

Magnetic Resonance Imaging (MRI) in Patients With Pacemakers and Implanted Cardioverter Defibrillators

2015. "Magnetic Resonance Imaging (MRI) in Patients With Pacemakers and Implanted Cardioverter Defibrillators". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02888353.