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MRI Safety for Pacemaker/Defibrillator Patients

N/A

Recruiting

Led By Charles Henrikson, MD

Research Sponsored by Oregon Health and Science University

Eligibility Criteria Checklist

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

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during mri scan.

Awards & highlights

Study Summary

This trial is looking at whether MRIs are safe for patients with pacemakers or defibrillators.

Who is the study for?

This trial is for patients who need an MRI and have a pacemaker (made after 1996) or defibrillator (made after 2000). It's not for pregnant women in their first trimester, those with old or certain problematic heart device leads, people under 80 lbs, or anyone unsuitable for MRI.Check my eligibility

What is being tested?

The study is examining the safety and outcomes of performing medically necessary MRIs on patients with newer models of permanent pacemakers and implantable cardioverter defibrillators.See study design

What are the potential side effects?

Since this trial involves standard MRI procedures, side effects may include discomfort from lying still during the scan, loud noises from the machine, and anxiety. There are no additional side effects expected from the MRI itself.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-6 week follow up in device clinic

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-6 week follow up in device clinic

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-6 week follow up in device clinic for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

MRI Safety during MRI scan in patients with PPMs/ICDs.

MRI Safety following MRI scan in patients with PPMs/ICDs.

Trial Design

1Treatment groups

Experimental Treatment

Group I: the studyExperimental Treatment1 Intervention

Patients with a PPM or ICD getting a clinically indicated MRI

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MRI

2009

Completed Phase 2

~1370

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor

974 Previous Clinical Trials

7,375,912 Total Patients Enrolled

Charles Henrikson, MDPrincipal Investigator - Oregon Health and Science University

Doernbecher Children's Hospital, OHSU Healthcare

Columbia University College Of Physicians And Surgeons (Medical School)

Johns Hopkins University School Medicine (Residency)

5 Previous Clinical Trials

1,167 Total Patients Enrolled

Media Library

the study Clinical Trial Eligibility Overview. Trial Name: NCT03915015 — N/A

Magnetic Resonance Imaging (MRI) Research Study Groups: the study

Magnetic Resonance Imaging (MRI) Clinical Trial 2023: the study Highlights & Side Effects. Trial Name: NCT03915015 — N/A

the study 2023 Treatment Timeline for Medical Study. Trial Name: NCT03915015 — N/A

Frequently Asked Questions

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

Does this research include individuals younger than 60 years old?

"To participate in this research project, individuals need to be between 9 and 99 years old. There are specialised studies for those under 18 as well as people over the age of 65, with 6 options for the former demographic and 34 for the latter."

Answered by AI

Are there still opportunities for individuals to participate in this experimentation?

"The information available on clinicaltrials.gov confirms that this trial is actively recruiting patients as of October 3rd 2020, a date which marks the most recent update to the study since its initial posting on July 19th 2012."

Answered by AI

What criteria must be met for someone to qualify as a participant in this investigation?

"Patients who qualify for this medical trial must have had an MRI scan, and be between 9 to 99 years of age. Approximately 10,000 individuals are eligible for enrollment."

Answered by AI

What is the current size of enrollment for this medical research project?

"Confirmed. According to the clinicaltrials.gov website, this study is actively looking for participants and was initially posted on July 19th 2012 with a recent update occurring on October 3rd 2020. 10000 people are needed from two sites in order to complete it."

Answered by AI

Recent research and studies

Journal of Interventional Cardiac ElectrophysiologyJournal

Magnetic Resonance Imaging in Patients with Cardiac Implantable Electronic Devices: A Single-center Prospective Study

Yadava, Mrinal, Matthew Nugent, Angela Krebsbach, Jessica Minnier, Peter Jessel, and Charles A. Henrikson. 2017. “Magnetic Resonance Imaging in Patients with Cardiac Implantable Electronic Devices: A Single-center Prospective Study”. Journal of Interventional Cardiac Electrophysiology. Springer Science and Business Media LLC. doi:10.1007/s10840-017-0262-6.

Annals of Internal MedicineJournal

A Prospective Evaluation of a Protocol for Magnetic Resonance Imaging of Patients with Implanted Cardiac Devices

Nazarian, Saman, Rozann Hansford, Ariel Roguin, Dorith Goldsher, Menekhem M. Zviman, Albert C. Lardo, Brian S. Caffo, et al.. 2011. “A Prospective Evaluation of a Protocol for Magnetic Resonance Imaging of Patients with Implanted Cardiac Devices”. Annals of Internal Medicine. American College of Physicians. doi:10.7326/0003-4819-155-7-201110040-00004.

Annals of Internal MedicineJournal

A Prospective Evaluation of a Protocol for Magnetic Resonance Imaging of Patients with Implanted Cardiac Devices

clinicaltrials.govStudy

VAPORHCS/OHSU J: MRI and Devices