Patients With Implantable Cardiac Devices Requiring a Nuclear Magnetic Resonance

Last updated: April 12, 2020
Sponsor: Trialance SCCL
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04330898
RMN01
  • Ages > 19
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients carrying a cardiac stimulation device

  • Patients able to understand the nature of the procedure

  • Patients who give informed consent

Exclusion

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

Total Participants: 1248
Study Start date:
May 02, 2017
Estimated Completion Date:
July 30, 2020

Study 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

Connect with a study center

  • Hospital San Pedro de Alcantara

    Cáceres, Madrid 28015
    Spain

    Active - Recruiting

  • Hospital de Poniente

    El Ejido, Madrid 28015
    Spain

    Active - Recruiting

  • Hospital Arquitecto Marcide

    Ferrol, Madrid 28015
    Spain

    Active - Recruiting

  • Hospital de Galdakano

    Galdakao, Madrid 28015
    Spain

    Active - Recruiting

  • Hospital de Orense

    Orense, Madrid 28015
    Spain

    Active - Recruiting

  • Hospital General de Asturias

    Oviedo, Madrid 28015
    Spain

    Active - Recruiting

  • Hospital Virgen del Puerto

    Plasencia, Madrid 28015
    Spain

    Site Not Available

  • Hospital de Puerto Real

    Puerto Real, Madrid 28015
    Spain

    Active - Recruiting

  • Hospital Parc Taul'i

    Sabadell, Madrid 28015
    Spain

    Active - Recruiting

  • Hospital Marques de Valdecilla

    Santander, Madrid 28015
    Spain

    Active - Recruiting

  • Hospital Rio Hortega

    Valladolid, Madrid 28015
    Spain

    Active - Recruiting

  • Hospital Universitatis de Araba

    Vitoria, Madrid 28015
    Spain

    Active - Recruiting

  • Hospital General de Alicante

    Alicante,
    Spain

    Active - Recruiting

  • Hospital San Juan de Alicante

    Alicante,
    Spain

    Active - Recruiting

  • Hospital de Cruces

    Barakaldo,
    Spain

    Active - Recruiting

  • Hospital Clinic

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital de Bellvitge

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital Puerta de Hierro

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Costa del Sol

    Marbella,
    Spain

    Active - Recruiting

  • Hospital Virgen de la Victoria

    Málaga,
    Spain

    Active - Recruiting

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