Patients With Implantable Cardiac Devices Requiring a Nuclear Magnetic Resonance
NCT ID: NCT04330898
Last Updated: 2020-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1248 participants
OBSERVATIONAL
2017-05-02
2020-07-30
Brief Summary
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Detailed Description
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Current data indicate that, with cardiological control and maintaining basic safety precautions, MRI could be performed in patients with peacemakers and Implantable Cardioverter Defibrillators (ICD) that require it for clinical reasons, although it should be noted that currently, due to lack of data published, the absolute safety of an MRI in these patients and the protocol used in each case cannot be guaranteed.
This registry proposal is to have data of all patients implanted with Biotronik cardiac stimulation devices and evaluate how many of them have an indication for an MRI-based diagnostic test, how many of them are already undergoing this diagnostic test, how many are given an tomography as an alternative to avoid subjecting patients to an MRI
Conditions
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Study Design
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OTHER
PROSPECTIVE
Interventions
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Biotronik peacemakers, implantable cardioverter-defibrillators and cardiac resynchronizers
Any of these Biotronik cardiac stimulation devices with the Home Monitoring function activated for the remote control of patients
Eligibility Criteria
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Inclusion Criteria
* Patients able to understand the nature of the procedure
* Patients who give informed consent
Exclusion Criteria
* Abandoned cables
* Non-BIOTRONIK cables
* Age \<18 years
* Pregnant and breastfeeding
* Subjects with irreversible brain damage caused by a pre-existing brain disease
* Heart transplant 6 months prior to recruitment or expected within the next 3 months
* Cardiac surgery 3 months prior to recruitment or planned for the next 3 months
* Life expectancy less than 12 months
19 Years
ALL
No
Sponsors
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Trialance SCCL
INDUSTRY
Responsible Party
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Principal Investigators
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Francisco Javier Alzueta, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Virgen de la Victoria
Francisco Ruiz Mateas, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Costa del Sol
Locations
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Hospital San Pedro de Alcantara
Cáceres, Madrid, Spain
Hospital de Poniente
El Ejido, Madrid, Spain
Hospital Arquitecto Marcide
Ferrol, Madrid, Spain
Hospital de Galdakano
Galdakao, Madrid, Spain
Hospital de Orense
Orense, Madrid, Spain
Hospital General de Asturias
Oviedo, Madrid, Spain
Hospital Virgen del Puerto
Plasencia, Madrid, Spain
Hospital de Puerto Real
Puerto Real, Madrid, Spain
Hospital Parc Taul'i
Sabadell, Madrid, Spain
Hospital Marques de Valdecilla
Santander, Madrid, Spain
Hospital Rio Hortega
Valladolid, Madrid, Spain
Hospital Universitatis de Araba
Vitoria, Madrid, Spain
Hospital General de Alicante
Alicante, , Spain
Hospital San Juan de Alicante
Alicante, , Spain
Hospital de Cruces
Barakaldo, , Spain
Hospital Clinic
Barcelona, , Spain
Hospital de Bellvitge
Barcelona, , Spain
Hospital Puerta de Hierro
Madrid, , Spain
Hospital Costa del Sol
Marbella, , Spain
Hospital Virgen de la Victoria
Málaga, , Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Marcu CB, Beek AM, van Rossum AC. Clinical applications of cardiovascular magnetic resonance imaging. CMAJ. 2006 Oct 10;175(8):911-7. doi: 10.1503/cmaj.060566.
Durack DT, Lukes AS, Bright DK. New criteria for diagnosis of infective endocarditis: utilization of specific echocardiographic findings. Duke Endocarditis Service. Am J Med. 1994 Mar;96(3):200-9. doi: 10.1016/0002-9343(94)90143-0.
Kanal E, Borgstede JP, Barkovich AJ, Bell C, Bradley WG, Etheridge S, Felmlee JP, Froelich JW, Hayden J, Kaminski EM, Lester JW Jr, Scoumis EA, Zaremba LA, Zinninger MD; American College of Radiology. American College of Radiology White Paper on MR Safety: 2004 update and revisions. AJR Am J Roentgenol. 2004 May;182(5):1111-4. doi: 10.2214/ajr.182.5.1821111. No abstract available.
Gold MR, Sommer T, Schwitter J, Al Fagih A, Albert T, Merkely B, Peterson M, Ciuffo A, Lee S, Landborg L, Cerkvenik J, Kanal E; Evera MRI Study Investigators. Full-Body MRI in Patients With an Implantable Cardioverter-Defibrillator: Primary Results of a Randomized Study. J Am Coll Cardiol. 2015 Jun 23;65(24):2581-2588. doi: 10.1016/j.jacc.2015.04.047. Epub 2015 May 14.
Other Identifiers
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RMN01
Identifier Type: -
Identifier Source: org_study_id
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