Patients With Implantable Cardiac Devices Requiring a Nuclear Magnetic Resonance
RESONANCE
Spanish Registry of Patients With Implantable Cardiac Devices That Require a Diagnostic Imaging Test With Nuclear Magnetic Resonance
1 other identifier
observational
1,248
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2017
Typical duration for all trials
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 2, 2017
CompletedFirst Submitted
Initial submission to the registry
December 9, 2019
CompletedFirst Posted
Study publicly available on registry
April 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2020
CompletedApril 14, 2020
April 1, 2020
3.2 years
December 9, 2019
April 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of patients with implantable cardiac devices that require a diagnostic test based on MRI
statistical analysis of the variable
1 year
Secondary Outcomes (5)
Primary indication for MRI
1 year
Reasons for not used MRI
1 year
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
1 year
Cost effectiveness of the he MRI Autodetect function
1 year
Analysis of the differences in the workflow
1 year
Interventions
Any of these Biotronik cardiac stimulation devices with the Home Monitoring function activated for the remote control of patients
Eligibility Criteria
Population with an accepted indication of an implantable cardiac device, including pacemakers, defibrillators and cardiac resynchronizers
You may qualify if:
- Patients carrying a cardiac stimulation device
- Patients able to understand the nature of the procedure
- Patients who give informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Trialance SCCLlead
Study Sites (20)
Hospital San Pedro de Alcantara
Cáceres, Madrid, 28015, Spain
Hospital de Poniente
El Ejido, Madrid, 28015, Spain
Hospital Arquitecto Marcide
Ferrol, Madrid, 28015, Spain
Hospital de Galdakano
Galdakao, Madrid, 28015, Spain
Hospital de Orense
Orense, Madrid, 28015, Spain
Hospital General de Asturias
Oviedo, Madrid, 28015, Spain
Hospital Virgen del Puerto
Plasencia, Madrid, 28015, Spain
Hospital de Puerto Real
Puerto Real, Madrid, 28015, Spain
Hospital Parc Taul'i
Sabadell, Madrid, 28015, Spain
Hospital Marques de Valdecilla
Santander, Madrid, 28015, Spain
Hospital Rio Hortega
Valladolid, Madrid, 28015, Spain
Hospital Universitatis de Araba
Vitoria, Madrid, 28015, 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
Related Publications (4)
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.
PMID: 17030942BACKGROUNDDurack 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.
PMID: 8154507BACKGROUNDKanal 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.
PMID: 15100103BACKGROUNDGold 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.
PMID: 25982014RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francisco Javier Alzueta, MD, PhD
Hospital Virgen de la Victoria
- PRINCIPAL INVESTIGATOR
Francisco Ruiz Mateas, MD, PhD
Hospital Costa del Sol
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2019
First Posted
April 2, 2020
Study Start
May 2, 2017
Primary Completion
June 30, 2020
Study Completion
July 30, 2020
Last Updated
April 14, 2020
Record last verified: 2020-04