We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03016429
First Posted: January 10, 2017
Last Update Posted: February 13, 2017
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. Read our disclaimer for details.
Information provided by (Responsible Party):
Dan B. Kramer, Beth Israel Deaconess Medical Center
  Purpose
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.

Condition
Cardiac Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Safety and Clinical Outcomes of Magnetic Resonance Imaging in Patients With Cardiac Implantable Electrical Devices

Resource links provided by NLM:


Further study details as provided by Dan B. Kramer, Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • 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

  • 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%


Estimated Enrollment: 500
Study Start Date: December 2016
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
  Contacts and Locations
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): NCT03016429


Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Daniel Kramer, MD Beth Israel Deaconess Medical Center
  More Information

Publications:
Levine GN, Gomes AS, Arai AE, Bluemke DA, Flamm SD, Kanal E, Manning WJ, Martin ET, Smith JM, Wilke N, Shellock FS; American Heart Association Committee on Diagnostic and Interventional Cardiac Catheterization; American Heart Association Council on Clinical Cardiology; American Heart Association Council on Cardiovascular Radiology and Intervention. Safety of magnetic resonance imaging in patients with cardiovascular devices: an American Heart Association scientific statement from the Committee on Diagnostic and Interventional Cardiac Catheterization, Council on Clinical Cardiology, and the Council on Cardiovascular Radiology and Intervention: endorsed by the American College of Cardiology Foundation, the North American Society for Cardiac Imaging, and the Society for Cardiovascular Magnetic Resonance. Circulation. 2007 Dec 11;116(24):2878-91. Epub 2007 Nov 19.

Responsible Party: Dan B. Kramer, Assistant Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT03016429     History of Changes
Other Study ID Numbers: 2016P000204
First Submitted: January 6, 2017
First Posted: January 10, 2017
Last Update Posted: February 13, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dan B. Kramer, Beth Israel Deaconess Medical Center:
pacemaker
defibrillator
magnetic resonance imaging
cardiac implantable electronic device

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases