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

Study Timeline

• Study Start: 2017-05-02
• Study First Submitted: 2019-12-09
• Study First Submitted QC: 2020-03-30
• Status Verified: 2020-04
• Study First Posted: 2020-04-02
• Last Update Submitted: 2020-04-12
• Last Update Posted: 2020-04-14
• Primary Completion: 2020-06-30
• Study Completion: 2020-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1248

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

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
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
Primary indication for MRI	1 year	statistical analysis of the variable

Trial Locations

Locations (20)

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

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