Clinical trial NCT04330898: Patients With Implantable Cardiac Devices Requiring a Nuclear Magnetic Resonance
Official title: Spanish Registry of Patients With Implantable Cardiac Devices That Require a Diagnostic Imaging Test With Nuclear Magnetic Resonance
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Implantable Cardiac Device. Patients With a NMR Indication
Keywords: Peacemaker
implantable cardioverter-defibrillator
Nuclear Magnetic Resonance
Lead sponsor: Trialance SCCL
Sponsor class: INDUSTRY
First posted: 2020-04-02
Enrollment: 1248
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Population with an accepted indication of an implantable cardiac device, including pacemakers, defibrillators and cardiac resynchronizers

Brief summary: The general objective of this registry is to study the number of patients carrying an implantable cardiac device that have an indication for an imaging diagnosis based on nuclear magnetic resonance. Is wanted to know the cause of the indication of the diagnostic test based on MRI.

Detailed description: MRI is currently infra indicated in patients with cardiac stimulation devices and for this reason, the request for this imaging technique in these patients is complicated and, often, the MRI-based test is replaced by a CT scan that may not be so beneficial for the diagnosis.

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

Eligibility criteria: Inclusion Criteria:

* Patients carrying a cardiac stimulation device
* Patients able to understand the nature of the procedure
* Patients who give informed consent

Exclusion Criteria:

* Epicardial cables
* 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

Primary outcomes:
measure: Percentage of patients with implantable cardiac devices that require a diagnostic test based on MRI
timeFrame: 1 year
Secondary outcomes:
measure: Primary indication for MRI
timeFrame: 1 year
measure: Reasons for not used MRI
timeFrame: 1 year
measure: Percentage of patients with a non-MRI-based test diagnosis, although they had an indication for an MRI-based diagnostic test because of their disease
timeFrame: 1 year
measure: Cost effectiveness of the he MRI Autodetect function
timeFrame: 1 year
measure: Analysis of the differences in the workflow
timeFrame: 1 year
Other outcomes:
Locations:
city: Cáceres
country: Spain
facility: Hospital San Pedro de Alcantara
state: Madrid
city: El Ejido
country: Spain
facility: Hospital de Poniente
state: Madrid
city: Ferrol
country: Spain
facility: Hospital Arquitecto Marcide
state: Madrid
city: Galdakao
country: Spain
facility: Hospital de Galdakano
state: Madrid
city: Orense
country: Spain
facility: Hospital de Orense
state: Madrid
city: Oviedo
country: Spain
facility: Hospital General de Asturias
state: Madrid
city: Plasencia
country: Spain
facility: Hospital Virgen del Puerto
state: Madrid
city: Puerto Real
country: Spain
facility: Hospital de Puerto Real
state: Madrid
city: Sabadell
country: Spain
facility: Hospital Parc Taul'i
state: Madrid
city: Santander
country: Spain
facility: Hospital Marques de Valdecilla
state: Madrid
city: Valladolid
country: Spain
facility: Hospital Rio Hortega
state: Madrid
city: Vitoria
country: Spain
facility: Hospital Universitatis de Araba
state: Madrid
city: Alicante
country: Spain
facility: Hospital General de Alicante
city: Alicante
country: Spain
facility: Hospital San Juan de Alicante
city: Barakaldo
country: Spain
facility: Hospital de Cruces
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Barcelona
country: Spain
facility: Hospital de Bellvitge
city: Madrid
country: Spain
facility: Hospital Puerta de Hierro
city: Marbella
country: Spain
facility: Hospital Costa del Sol
city: Málaga
country: Spain
facility: Hospital Virgen de la Victoria
Study officials:
affiliation: Hospital Virgen de la Victoria
name: Francisco Javier Alzueta, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Costa del Sol
name: Francisco Ruiz Mateas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.