Patients With Implantable Cardiac Devices Requiring a Nuclear Magnetic Resonance
- Conditions
- Implantable Cardiac Device. Patients With a NMR Indication
- Registration Number
- NCT04330898
- Lead Sponsor
- Trialance SCCL
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1248
- Patients carrying a cardiac stimulation device
- Patients able to understand the nature of the procedure
- Patients who give informed consent
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of patients with implantable cardiac devices that require a diagnostic test based on MRI 1 year statistical analysis of the variable
- Secondary Outcome Measures
Name Time Method Primary indication for MRI 1 year statistical analysis of the variable
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 statistical analysis of the variable
Cost effectiveness of the he MRI Autodetect function 1 year statistical analysis of the variable
Reasons for not used MRI 1 year statistical analysis of the variable
Analysis of the differences in the workflow 1 year statistical analysis of the variable
Trial Locations
- Locations (20)
Hospital General de Asturias
🇪🇸Oviedo, Madrid, Spain
Hospital General de Alicante
🇪🇸Alicante, Spain
Hospital San Juan de Alicante
🇪🇸Alicante, Spain
Hospital de Cruces
🇪🇸Barakaldo, Spain
Hospital de Bellvitge
🇪🇸Barcelona, Spain
Hospital Clinic
🇪🇸Barcelona, Spain
Hospital Puerta de Hierro
🇪🇸Madrid, Spain
Hospital Costa del Sol
🇪🇸Marbella, Spain
Hospital Virgen de la Victoria
🇪🇸Málaga, Spain
Hospital Rio Hortega
🇪🇸Valladolid, Madrid, Spain
Hospital de Poniente
🇪🇸El Ejido, Madrid, Spain
Hospital de Galdakano
🇪🇸Galdakao, Madrid, Spain
Hospital de Orense
🇪🇸Orense, Madrid, Spain
Hospital Virgen del Puerto
🇪🇸Plasencia, Madrid, Spain
Hospital Universitatis de Araba
🇪🇸Vitoria, Madrid, Spain
Hospital San Pedro de Alcantara
🇪🇸Cáceres, Madrid, Spain
Hospital Arquitecto Marcide
🇪🇸Ferrol, Madrid, Spain
Hospital de Puerto Real
🇪🇸Puerto Real, Madrid, Spain
Hospital Marques de Valdecilla
🇪🇸Santander, Madrid, Spain
Hospital Parc Taul'i
🇪🇸Sabadell, Madrid, Spain