Study to Monitor Patients With Pacemakers or ICDs Who Undergo MRI Scans

NCT01999751 | Completed

• 1 other identifier: EH12274
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, non-randomized, unblinded case series of patients with permanent pacemakers and implantable cardioverter-defibrillators undergoing medically-required magnetic resonance imaging (MRI) scanning, at St. Mary's Medical Center, Essentia Health. Patients will be enrolled over a 60-month period and followed for 12 months, with data collected to evaluate the study's primary endpoint, change in pacing thresholds over time, as well as a series of secondary endpoints, including: adverse events, symptoms, need to make pacemaker programming changes, and possible artifacts created by the pacemaker systems on the MRI scans. This study will allow for carefully monitoring of the safety MRI scanning in this population and improve practice models and protocols in the future.

Conditions

Arrhythmias, Cardiac

Keywords

Magnetic Resonance Imaging; Pacemaker, Artificial; Defibrillators, Implantable

Outcome Measures

Primary Outcomes (1)

• Pacing threshold increase

  Any change greater than 1 V at a pulse width of 0.5 msec in a pacemaker or implantable cardioverter-defibrillator lead at any time within 12 months of the MRI scan

  12 months

Secondary Outcomes (2)

• Ectopy

  1 hour

• Pacemaker reprogramming

  12 months

Study Arms (1)

MRI Scan

Patients with implantable cardioverter-defibrillator or pacemaker who undergo an MRI scan

Device: MRI Scan

Interventions

MRI Scan DEVICE

Clinically indicated MRI scan of patients with pacemaker or implantable cardioverter-defibrillator in situ.

MRI Scan

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

Any person followed at St. Mary's Medical Center, Duluth, MN, with a permanent pacemaker or implantable cardioverter-defibrillator implanted for at least 6 weeks, referred for a medically-required MRI scan by a physician or provider not participating in the trial. If patients elect not to participate, they may still receive an MRI and will sign the clinical consent. If they elect not to have an MRI, they will be referred back to the ordering provider to discuss other options.

You may qualify if:

• Permanent Pacemaker or ICD implanted for at least 6 weeks
• Referred for medically-required MRI scan
• Age greater than or equal to 18 years

You may not qualify if:

• ICD market released before 2001 including GDT Ventak-AV, GDT MINI-II, GDT MINI-IV, GDT MINI-III, GDT Prizm, GDT Prizm-2 and MDT GEM-I series
• Epicardial lead or subcutaneous array
• Device has reached elective replacement indicator (ERI) or end of life (EOL)
• Other usual contraindications to MRI scanning
• Known or suspected lead fracture or abandoned lead
• Pacemaker dependent patients with an ICD that cannot be programmed to asynchronous pacing (DOO/VOO)
• Clinical factors that are deemed by the PI or Sub-I to increase the participant's risk above an acceptable clinical threshold

Sponsors & Collaborators

• Essentia Health: lead

Study Sites (1)

St. Mary's Medical Center

Duluth, Minnesota, 55812, United States

Location

Related Publications (12)

• Hayes DL, Holmes DR Jr, Gray JE. Effect of 1.5 tesla nuclear magnetic resonance imaging scanner on implanted permanent pacemakers. J Am Coll Cardiol. 1987 Oct;10(4):782-6. doi: 10.1016/s0735-1097(87)80270-x.

  PMID: 3655146 BACKGROUND

• Goldschlager N, Epstein A, Friedman P, Gang E, Krol R, Olshansky B; North American Society of Pacing and Electrophysiology (NASPE) Practice Guideline Committee. Environmental and drug effects on patients with pacemakers and implantable cardioverter/defibrillators: a practical guide to patient treatment. Arch Intern Med. 2001 Mar 12;161(5):649-55. doi: 10.1001/archinte.161.5.649. No abstract available.

  PMID: 11231696 BACKGROUND

• Martin ET, Coman JA, Shellock FG, Pulling CC, Fair R, Jenkins K. Magnetic resonance imaging and cardiac pacemaker safety at 1.5-Tesla. J Am Coll Cardiol. 2004 Apr 7;43(7):1315-24. doi: 10.1016/j.jacc.2003.12.016.

  PMID: 15063447 BACKGROUND

• Erlebacher JA, Cahill PT, Pannizzo F, Knowles RJ. Effect of magnetic resonance imaging on DDD pacemakers. Am J Cardiol. 1986 Feb 15;57(6):437-40. doi: 10.1016/0002-9149(86)90768-x.

  PMID: 3946261 BACKGROUND

• Fetter J, Aram G, Holmes DR Jr, Gray JE, Hayes DL. The effects of nuclear magnetic resonance imagers on external and implantable pulse generators. Pacing Clin Electrophysiol. 1984 Jul;7(4):720-7. doi: 10.1111/j.1540-8159.1984.tb05602.x.

  PMID: 6205375 BACKGROUND

• Sommer T, Vahlhaus C, Lauck G, von Smekal A, Reinke M, Hofer U, Block W, Traber F, Schneider C, Gieseke J, Jung W, Schild H. MR imaging and cardiac pacemakers: in-vitro evaluation and in-vivo studies in 51 patients at 0.5 T. Radiology. 2000 Jun;215(3):869-79. doi: 10.1148/radiology.215.3.r00jn08869.

  PMID: 10831713 BACKGROUND

• Shellock FG, O'Neil M, Ivans V, Kelly D, O'Connor M, Toay L, Crues JV. Cardiac pacemakers and implantable cardioverter defibrillators are unaffected by operation of an extremity MR imaging system. AJR Am J Roentgenol. 1999 Jan;172(1):165-70. doi: 10.2214/ajr.172.1.9888762.

  PMID: 9888762 BACKGROUND

• Roguin A, Zviman MM, Meininger GR, Rodrigues ER, Dickfeld TM, Bluemke DA, Lardo A, Berger RD, Calkins H, Halperin HR. Modern pacemaker and implantable cardioverter/defibrillator systems can be magnetic resonance imaging safe: in vitro and in vivo assessment of safety and function at 1.5 T. Circulation. 2004 Aug 3;110(5):475-82. doi: 10.1161/01.CIR.0000137121.28722.33. Epub 2004 Jul 26.

  PMID: 15277324 BACKGROUND

• Nazarian S, Roguin A, Zviman MM, Lardo AC, Dickfeld TL, Calkins H, Weiss RG, Berger RD, Bluemke DA, Halperin HR. Clinical utility and safety of a protocol for noncardiac and cardiac magnetic resonance imaging of patients with permanent pacemakers and implantable-cardioverter defibrillators at 1.5 tesla. Circulation. 2006 Sep 19;114(12):1277-84. doi: 10.1161/CIRCULATIONAHA.105.607655. Epub 2006 Sep 11.

  PMID: 16966586 BACKGROUND

• Gimbel JR, Kanal E, Schwartz KM, Wilkoff BL. Outcome of magnetic resonance imaging (MRI) in selected patients with implantable cardioverter defibrillators (ICDs). Pacing Clin Electrophysiol. 2005 Apr;28(4):270-3. doi: 10.1111/j.1540-8159.2005.09520.x.

  PMID: 15826257 BACKGROUND

• Mollerus M, Albin G, Lipinski M, Lucca J. Magnetic resonance imaging of pacemakers and implantable cardioverter-defibrillators without specific absorption rate restrictions. Europace. 2010 Jul;12(7):947-51. doi: 10.1093/europace/euq092. Epub 2010 Mar 30.

  PMID: 20353963 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

MeSH Terms

Conditions

Arrhythmias, Cardiac

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Michael E Mollerus, MD

  Essentia Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: November 26, 2013
• First Posted: December 3, 2013
• Study Start: October 1, 2012
• Primary Completion: April 2, 2018
• Study Completion: April 11, 2018
• Last Updated: April 12, 2018

Record last verified: 2018-04

Locations

US (1)