Diagnostic Utility of Cardiac MRI

Официальное название

Evaluating the Safety and Diagnostic Utility of Cardiac MRI in Patients With Abandoned, Fractured Endocardial Leads or Permanent Epicardial Leads

Обзор

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).

Подробное описание

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Evaluating the safety of CMR [Срок оценки: 6 months]

Вторичные конечные точки (2)

• Diagnostic Value of CMR [Срок оценки: 6 months]
• Protocol Development. [Срок оценки: 2 years.]

Критерии участия

Критерии включения

• Individuals 18 years and older
• Individuals with abandoned, fractured endocardial
• Individuals with permanent epicardial pacemaker or implantable cardioverter-defibrillator (ICD) leads

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• Baylor Scott and White Vascular Hospital — Dallas

Публикации

• 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

Идентификаторы

NCT: NCT07679009 · 024-421

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗