Safety and Clinical Outcomes of Magnetic Resonance Imaging in Patients With Cardiac Implantable Electrical Devices (BIDMC-MRI)

July 19, 2022 updated by: Dan B. Kramer, Beth Israel Deaconess Medical Center
This protocol outlines a prospective study evaluating safety and clinical outcomes of magnetic resonance imaging (MRI) examinations performed on patients with cardiac implantable electrical devices (CIEDs) including pacemakers (PMs) and implantable cardioverter-defibrillators (ICDs). This prospective study aims to improve the evidence base regarding this common clinical scenario. Specifically, the investigators aim to address whether results of MRI in PM/ICD patients affect physician decision making related to clinical management strategy and planning treatment interventions. Further, this study will evaluate whether the results of MRI in these patients affects patient outcomes related to survival and adverse events during or after MRI scanning.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

MRI is the preferred imaging modality for both acute and elective evaluation of many conditions. For example, for many diseases of the central nervous system, no other imaging modality provides the requisite soft tissue resolution to support critical care elements such as neurosurgical planning or assessment of intracranial malignancies.

Historically, MRIs were considered contraindicated for patients with CIEDs including PMs and ICDs. However, studies have demonstrated very high utilization of MRIs among patients eligible for CIEDs. In many cases, alternative imaging is either insufficient or, as with CT-myelography, poses substantial risks or procedural hurdles that may be less favorable than the potential risks of an MRI.

In recent years, a growing literature has suggested that MRIs can be performed safely in the setting of CIEDs if certain precautions are taken. Additionally, guidance documents have been released by professional societies including the American Heart Association (AHA) and the American College of Radiology (ACR) outlining recommended safety measures that can be taken to minimize risk and maximize benefit for patients in need of imaging. However, there are fewer data on performing MRIs in pacemaker-dependent patients with ICDs, who were excluded from the largest published study as well as the MagnaSafe Registry. Thus, demonstrating the safety and clinical utility of performing MRIs in this context is of high importance.

In response to urgent clinical considerations, Beth Israel Deaconess Medical Center has established a clinical protocol to provide safe MRIs in cases of compelling clinical indications, with close supervision and oversight from Radiology and Cardiac Electrophysiology staff. Thus, the investigators now propose a prospective study to evaluate safety and clinical outcomes for patients treated under this clinical protocol.

Specifically, this study proposes to perform a prospective clinical trial in patients with CIEDs that have a clinical need for MRI as outpatients to determine:

  1. Safety according to the incidence rates of acute major and minor adverse events according to pre-specified definitions.
  2. Clinical outcomes and scan utility affecting patients' survival and quality of life and treatment, including acute and longitudinal changes in device parameters, the need for system revision, and proportion of MRI findings influencing clinical management including medical or surgical interventions, and diagnostic or prognostic changes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1169

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This is a prospective observational study of patients with a cardiac implantable electronic device (CIED) referred for a clinicially indicated MRI.

Description

Inclusion Criteria:

  • Patients have a medically/clinically indicated need for an MRI
  • Patients with a non-MRI conditional pacemaker and/or ICD implanted after the year 2000

  • Patients are willing and able to sign consent and HIPAA authorization or an authorized representative of the patient is willing to sign consent for the patient

    *The following factors are considered relative contraindications to the clinical protocol at BIDMC, and will similarly be considered exclusion criteria for the study. Exceptions on a case-by-case basis for circumstances of dire, life-threatening need may be considered.

  • Leads implanted <6 weeks prior to the MRI
  • Presence of any capped/abandoned leads
  • Presence of nontransvenous epicardial leads

Exclusion Criteria:

  • Other contraindications to MRI (e.g. other non-MRI-conditional implants)
  • Pacemaker or ICD implanted prior to the year 2000
  • Leads and/or generator implanted within 6 weeks of the proposed MRI
  • CIED that is FDA approved as MRI conditional
  • Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Patients with Any of the Following Major Adverse Events
Time Frame: Change from baseline at 1 week and 6 months
  1. Acute loss of pacing peri-MRI (defined in scanner, or after scan prior to discharge)
  2. Inappropriate shock or ATP therapy peri-MRI
  3. Any death peri-MRI adjudicated to be related to the scan
Change from baseline at 1 week and 6 months
Number of Patients with Any of the Following Minor Adverse Events
Time Frame: Change from baseline at 1 week and 6 months
  1. Clinically significant (symptoms or hemodynamic compromise) inappropriate pacing (e.g. undersensing or inappropriate asynchronous pacing)
  2. Any clinically significant arrhythmias peri-MRI
  3. Power-on-reset events
  4. Acute variation in pre/post MRI capture thresholds ≥ 50%
  5. Acute variation in pre/post MRI lead impedance ≥ 30%
  6. Acute variation in pre/post MRI P/R wave amplitude ≥ 50%
Change from baseline at 1 week and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beth Israel Deaconess Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Daniel Kramer, MD, Beth Israel Deaconess Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 5, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 5, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 6, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 20, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016P000204

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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