Patients With Implantable Cardiac Devices Requiring a Nuclear Magnetic Resonance

Implantable Cardiac Device. Patients With a NMR Indication Clinical Trial

— RESONANCE  

Official title:

Spanish Registry of Patients With Implantable Cardiac Devices That Require a Diagnostic Imaging Test With Nuclear Magnetic Resonance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04330898
• Other study ID #: RMN01
• Status: Recruiting
• Start date: May 2, 2017
• Est. completion date: July 30, 2020

Study information

• Verified date: April 2020
• Source: Trialance SCCL
• Contact: Xavier Molina Figueras, PharmD, PhD
• Phone: + 34 689900009
• Email: xmolina[@]trialance.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1248
• Est. completion date: July 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Implantable Cardiac Device. Patients With a NMR Indication

Intervention

Device:
• 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

Locations

Country	Name	City	State
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 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 Puerta de Hierro	Madrid
Spain	Hospital Virgen de la Victoria	Málaga
Spain	Hospital Costa del Sol	Marbella
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

Sponsors (1)

Lead Sponsor	Collaborator
Trialance SCCL

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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. — View 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 R — View 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. — View Citation

Marcu CB, Beek AM, van Rossum AC. Clinical applications of cardiovascular magnetic resonance imaging. CMAJ. 2006 Oct 10;175(8):911-7. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with implantable cardiac devices that require a diagnostic test based on MRI	statistical analysis of the variable	1 year
Secondary	Primary indication for MRI	statistical analysis of the variable	1 year
Secondary	Reasons for not used MRI	statistical analysis of the variable	1 year
Secondary	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	statistical analysis of the variable	1 year
Secondary	Cost effectiveness of the he MRI Autodetect function	statistical analysis of the variable	1 year
Secondary	Analysis of the differences in the workflow	statistical analysis of the variable	1 year