St. Mary's Duluth Clinic (SMDC) Pacemaker Magnetic Resonance Imaging (MRI) Study - Full Text View

Purpose

The purpose of this study is to monitor and follow non-pacemaker dependent patients with implanted permanent pacemakers, who undergo medically required Magnetic Resonance Imaging (MRI) scans.

Patients with pacemakers are currently excluded from obtaining MRI scans. MRI scanning is now the imaging of choice for a number of neurological, vascular, or musculoskeletal conditions.

Data suggests that patients with pacemakers, when properly monitored, can safely undergo MRI scanning, though the largest published study to date consists of 54 patients, and no long term follow-up has been published.

Though MRI cardiac scanning has been demonstrated to produce local tissue heating at the pacemaker lead tip, the long term effect of tissue heating on lead stability is unclear.

This study will evaluate patients with permanent pacemakers undergoing medically indicated MRI scanning.

Patients will be followed for one year at 3, 6, and 12 months. Data collected will evaluate change in pacing thresholds over time as well as cardiac troponin I, creatinine kinase MB function, and myoglobin levels within the first 12 hours following the scans, side effects, symptoms, the need to make pacemaker program changes, and possible artifacts created by the pacemaker on the MRI scan.

Condition
Cardiovascular Disease

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	SMDC Pacemaker-MRI Cohort Study

Resource links provided by NLM:

MedlinePlus related topics: MRI Scans Nuclear Scans

U.S. FDA Resources

Further study details as provided by Essentia Health:

Primary Outcome Measures:

Any change greater than 1 volt at a pulse width of 0.5 ms in a pacemaker lead 12 months from an MRI scan [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Cardiac troponin-I, creatine kinase, MB fraction, and myoglobin levels within the first 12 hours following the scans. [ Time Frame: 12 hours ] [ Designated as safety issue: Yes ]

Enrollment:	150
Study Start Date:	January 2005
Study Completion Date:	July 2011
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
Single Observation Patients with permanent pacemakers undergoing medically indicated MRI scanning.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Permanent pacemaker or implantable cardioverter-defibrillator (ICD) implanted for at least 6 weeks.

Criteria

Inclusion Criteria:

Permanent pacemaker or ICD implanted for at least 6 weeks
Referred for medically indicated MRI
Age greater or equal to 18 years old

Exclusion Criteria:

ICD market released before 2001 including GDT Ventak-AV, GDT MINI-II, GDT MINI-IV, GDT MINI-III, GDT Prizm-2 MDT GEM-I series
Epicardial coronary sinus lead or subcutaneous array
Unable to program all leads to bipolar configuration
Pacemaker Dependent
Device has reached elective replacement or end of life
Other usual contraindications to MRI scanning
The use of inotropic pharmacological agents, such as dobutamine, during the MRI

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631904

Locations

United States, Minnesota
Essentia Health
Duluth, Minnesota, United States, 55805

Sponsors and Collaborators

Essentia Health

Investigators

Principal Investigator:

Michael Mollerus, MD

Essentia Health

More Information

Publications:

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.

Sommer T, Vahlhaus C, Lauck G, von Smekal A, Reinke M, Hofer U, Block W, Träber 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.

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.

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. Epub 2004 Jul 26.

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. Epub 2006 Sep 11.

Gimbel JR, Bailey SM, Tchou PJ, Ruggieri PM, Wilkoff BL. Strategies for the safe magnetic resonance imaging of pacemaker-dependent patients. Pacing Clin Electrophysiol. 2005 Oct;28(10):1041-6.

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.

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. Review. No abstract available.

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.

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.

Responsible Party:	Michael Mollerus, MD, Essentia Health
ClinicalTrials.gov Identifier:	NCT00631904 History of Changes
Other Study ID Numbers:	010503
Study First Received:	February 29, 2008
Last Updated:	August 31, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Essentia Health:

Pacemaker

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013