Diagnostic Utility of Cardiac MRI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cardiac MRI (CMR).
- Who it may be relevant to
- Registry conditions: Abandoned Endocardial Leads, Broken Endocardial Leads, Permanent Epicardial Leads. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluating the Safety and Diagnostic Utility of Cardiac MRI in Patients With Abandoned, Fractured Endocardial Leads or Permanent Epicardial Leads
Overview
This is a prospective cohort study looking to systematically evaluate the safety of conducting cardiac Magnetic Resonance Imaging (MRI) in this high-risk patient group with abandoned, fractured endocardial leads or surgically implanted permanent epicardial leads, by monitoring clinical outcome and device functionality (if active device present).
Detailed description
This is a prospective cohort study involving patients with abandoned, fractured endocardial leads, or surgically placed permanent epicardial leads with or without concurrent active cardiac implantable electronic devices (CIEDs), who need cardiac MRI for clinical indications. Participants will undergo a thorough pre-scan evaluation, including chest x-ray (CXR), device interrogation, lead integrity check, and risk assessment. The MRI will be performed using a standardized protocol designed to minimize risks, with continuous patient monitoring during the procedure. Post-scan device interrogation and patient evaluation will assess any immediate and delayed adverse effects.
This study is a descriptive case series, and no statistical comparisons with controls will be made. Descriptive statistics of continuous patient and CIED variables are expressed as the mean+/- SDs (standard deviations), or as medians with interquartile ranges (IOR). Categorical variables are expressed as numbers and percentages.
Interventions
- Device Cardiac MRI (CMR)
Conducting cardiac MRI in a high-risk patient group with abandoned, fractured endocardial leads or surgically implanted permanent epicardial leads, by monitoring clinical outcome and device functionality (if active device present) to determine the diagnostic value of Cardiac MRI in these patients.
Primary outcome measures
- Evaluating the safety of CMR [Time frame: 6 months]
Secondary outcome measures (2)
- Diagnostic Value of CMR [Time frame: 6 months]
- Protocol Development. [Time frame: 2 years.]
Eligibility criteria
Inclusion criteria
- Individuals 18 years and older
- Individuals with abandoned, fractured endocardial
- Individuals with permanent epicardial pacemaker or implantable cardioverter-defibrillator (ICD) leads
Exclusion criteria
Within 6 weeks post device implantation, unless more urgent clinical needs dictate an earlier scan;
- Pregnant individuals
- Individuals with severe claustrophobia
- Individuals with other known contraindications for MRI, as determined by study doctor
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Baylor Scott and White Vascular Hospital — Dallas
Publications
- Langman DA, Finn JP, Ennis DB. Abandoned pacemaker leads are a potential risk for patients undergoing MRI. Pacing Clin Electrophysiol. 2011 Sep;34(9):1051-3. doi: 10.1111/j.1540-8159.2011.03176.x. Epub 2011 Jul 28. No abstract available. PMID 21797902
- Russo RJ, Costa HS, Silva PD, Anderson JL, Arshad A, Biederman RW, Boyle NG, Frabizzio JV, Birgersdotter-Green U, Higgins SL, Lampert R, Machado CE, Martin ET, Rivard AL, Rubenstein JC, Schaerf RH, Schwartz JD, Shah DJ, Tomassoni GF, Tominaga GT, Tonkin AE, Uretsky S, Wolff SD. Assessing the Risks Associated with MRI in Patients with a Pacemaker or Defibrillator. N Engl J Med. 2017 Feb 23;376(8):7 PMID 28225684
- Indik JH, Gimbel JR, Abe H, Alkmim-Teixeira R, Birgersdotter-Green U, Clarke GD, Dickfeld TL, Froelich JW, Grant J, Hayes DL, Heidbuchel H, Idriss SF, Kanal E, Lampert R, Machado CE, Mandrola JM, Nazarian S, Patton KK, Rozner MA, Russo RJ, Shen WK, Shinbane JS, Teo WS, Uribe W, Verma A, Wilkoff BL, Woodard PK. 2017 HRS expert consensus statement on magnetic resonance imaging and radiation exposure PMID 28502708
- Balmer C, Gass M, Dave H, Duru F, Luechinger R. Magnetic resonance imaging of patients with epicardial leads: in vitro evaluation of temperature changes at the lead tip. J Interv Card Electrophysiol. 2019 Dec;56(3):321-326. doi: 10.1007/s10840-019-00627-7. Epub 2019 Nov 12. PMID 31713219
- Vuorinen AM, Pakarinen S, Jaakkola I, Holmstrom M, Kivisto S, Kaasalainen T. Clinical experience of magnetic resonance imaging in patients with cardiac pacing devices: unrestricted patient population. Acta Radiol. 2019 Nov;60(11):1414-1421. doi: 10.1177/0284185119830288. Epub 2019 Feb 19. PMID 30781967
- Padmanabhan D, Kella DK, Mehta R, Kapa S, Deshmukh A, Mulpuru S, Jaffe AS, Felmlee JP, Jondal ML, Dalzell CM, Asirvatham SJ, Cha YM, Watson RE Jr, Friedman PA. Safety of magnetic resonance imaging in patients with legacy pacemakers and defibrillators and abandoned leads. Heart Rhythm. 2018 Feb;15(2):228-233. doi: 10.1016/j.hrthm.2017.10.022. Epub 2017 Oct 16. PMID 29045806
- Gakenheimer-Smith L, Etheridge SP, Niu MC, Ou Z, Presson AP, Whitaker P, Su J, Puchalski MD, Asaki SY, Pilcher T. MRI in pediatric and congenital heart disease patients with CIEDs and epicardial or abandoned leads. Pacing Clin Electrophysiol. 2020 Aug;43(8):797-804. doi: 10.1111/pace.13984. Epub 2020 Jul 6. PMID 32533566
- Schaller RD, Brunker T, Riley MP, Marchlinski FE, Nazarian S, Litt H. Magnetic Resonance Imaging in Patients With Cardiac Implantable Electronic Devices With Abandoned Leads. JAMA Cardiol. 2021 May 1;6(5):549-556. doi: 10.1001/jamacardio.2020.7572. PMID 33595595
Identifiers
NCT: NCT07679009 · 024-421