Safety and Clinical Outcomes of Magnetic Resonance Imaging in Patients With Cardiac Implantable Electrical Devices

NCT03016429 | Completed

• 1 other identifier: 2016P000204
• Study Type: observational
• Target: 1,169
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Disease

Keywords

pacemaker; defibrillator; magnetic resonance imaging; cardiac implantable electronic device

Outcome Measures

Primary Outcomes (2)

• Number of Patients with Any of the Following Major Adverse Events

  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

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (10)

• Nazarian S, Reynolds MR, Ryan MP, Wolff SD, Mollenkopf SA, Turakhia MP. Utilization and likelihood of radiologic diagnostic imaging in patients with implantable cardiac defibrillators. J Magn Reson Imaging. 2016 Jan;43(1):115-27. doi: 10.1002/jmri.24971. Epub 2015 Jun 27.

  PMID: 26118943 BACKGROUND

• Smith-Bindman R, Miglioretti DL, Larson EB. Rising use of diagnostic medical imaging in a large integrated health system. Health Aff (Millwood). 2008 Nov-Dec;27(6):1491-502. doi: 10.1377/hlthaff.27.6.1491.

  PMID: 18997204 BACKGROUND

• Naehle CP, Strach K, Thomas D, Meyer C, Linhart M, Bitaraf S, Litt H, Schwab JO, Schild H, Sommer T. Magnetic resonance imaging at 1.5-T in patients with implantable cardioverter-defibrillators. J Am Coll Cardiol. 2009 Aug 4;54(6):549-55. doi: 10.1016/j.jacc.2009.04.050.

  PMID: 19643318 BACKGROUND

• Naehle CP, Meyer C, Thomas D, Remerie S, Krautmacher C, Litt H, Luechinger R, Fimmers R, Schild H, Sommer T. Safety of brain 3-T MR imaging with transmit-receive head coil in patients with cardiac pacemakers: pilot prospective study with 51 examinations. Radiology. 2008 Dec;249(3):991-1001. doi: 10.1148/radiol.2493072195.

  PMID: 19011193 BACKGROUND

• Sommer T, Naehle CP, Yang A, Zeijlemaker V, Hackenbroch M, Schmiedel A, Meyer C, Strach K, Skowasch D, Vahlhaus C, Litt H, Schild H. Strategy for safe performance of extrathoracic magnetic resonance imaging at 1.5 tesla in the presence of cardiac pacemakers in non-pacemaker-dependent patients: a prospective study with 115 examinations. Circulation. 2006 Sep 19;114(12):1285-92. doi: 10.1161/CIRCULATIONAHA.105.597013. Epub 2006 Sep 11.

  PMID: 16966587 BACKGROUND

• Nazarian S, Hansford R, Roguin A, Goldsher D, Zviman MM, Lardo AC, Caffo BS, Frick KD, Kraut MA, Kamel IR, Calkins H, Berger RD, Bluemke DA, Halperin HR. A prospective evaluation of a protocol for magnetic resonance imaging of patients with implanted cardiac devices. Ann Intern Med. 2011 Oct 4;155(7):415-24. doi: 10.7326/0003-4819-155-7-201110040-00004.

  PMID: 21969340 BACKGROUND

• Expert Panel on MR Safety; Kanal E, Barkovich AJ, Bell C, Borgstede JP, Bradley WG Jr, Froelich JW, Gimbel JR, Gosbee JW, Kuhni-Kaminski E, Larson PA, Lester JW Jr, Nyenhuis J, Schaefer DJ, Sebek EA, Weinreb J, Wilkoff BL, Woods TO, Lucey L, Hernandez D. ACR guidance document on MR safe practices: 2013. J Magn Reson Imaging. 2013 Mar;37(3):501-30. doi: 10.1002/jmri.24011. Epub 2013 Jan 23.

  PMID: 23345200 BACKGROUND

• 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. doi: 10.1161/CIRCULATIONAHA.107.187256. Epub 2007 Nov 19.

  PMID: 18025533 BACKGROUND

• Russo RJ. Determining the risks of clinically indicated nonthoracic magnetic resonance imaging at 1.5 T for patients with pacemakers and implantable cardioverter-defibrillators: rationale and design of the MagnaSafe Registry. Am Heart J. 2013 Mar;165(3):266-72. doi: 10.1016/j.ahj.2012.12.004. Epub 2013 Jan 28.

  PMID: 23453091 BACKGROUND

• Cohen JD, Costa HS, Russo RJ. Determining the risks of magnetic resonance imaging at 1.5 tesla for patients with pacemakers and implantable cardioverter defibrillators. Am J Cardiol. 2012 Dec 1;110(11):1631-6. doi: 10.1016/j.amjcard.2012.07.030. Epub 2012 Aug 23.

  PMID: 22921995 BACKGROUND

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Daniel Kramer, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: January 6, 2017
• First Posted: January 10, 2017
• Study Start: December 1, 2016
• Primary Completion: March 5, 2021
• Study Completion: March 5, 2021
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)