Patients With Implantable Cardiac Devices Requiring a Nuclear Magnetic Resonance (RESONANCE)

April 12, 2020 updated by: Trialance SCCL

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

1248

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alicante, Spain
        • Recruiting
        • Hospital General de Alicante
        • Contact:
        • Contact:
        • Principal Investigator:
          • Juan Gabriel Martinez, Cardiology
        • Sub-Investigator:
          • Raquel Ajo Ferrer, Cardiology
      • Alicante, Spain
        • Recruiting
        • Hospital San Juan de Alicante
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vicente Bartomeu Gonzalez, Cardiology
      • Barakaldo, Spain
        • Recruiting
        • Hospital de Cruces
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ignacio Andres Bodegas Canas, Cardiology
        • Sub-Investigator:
          • I;into Sauna Godoy, MD,Cardiology
      • Barcelona, Spain
        • Recruiting
        • Hospital Clinic
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jose Maria Tolosana, Cardiology
        • Sub-Investigator:
          • Rodolfo San Antonio, Cardiology
      • Barcelona, Spain
        • Recruiting
        • Hospital De Bellvitge
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ignasi Anguera Camós, Cardiology
        • Sub-Investigator:
          • Marcos Rodriguez, Cardiology
      • Madrid, Spain
        • Recruiting
        • Hospital Puerta de Hierro
        • Principal Investigator:
          • Ignacio Fernández Lozano, Cardiologist
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Diego Jiménez Sánchez, Cardiologist
      • Marbella, Spain
        • Recruiting
        • Hospital Costa del Sol
        • Contact:
        • Contact:
        • Principal Investigator:
          • Francisco Ruiz Mateas, MD
      • Málaga, Spain
        • Recruiting
        • Hospital Virgen de la Victoria
        • Contact:
        • Contact:
        • Principal Investigator:
          • Javier Alzueta Rodríguez, Cardiologist
        • Sub-Investigator:
          • Thor Cruzado Maldonado, Cardiologist
    • Madrid
      • Cáceres, Madrid, Spain, 28015
        • Recruiting
        • Hospital San Pedro de Alcantara
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maria Jose Garcia Ramos, Cardiology
      • El Ejido, Madrid, Spain, 28015
        • Recruiting
        • Hospital de Poniente
        • Contact:
        • Contact:
        • Principal Investigator:
          • Javier Fierro Rosón, Intensivist
        • Sub-Investigator:
          • Sofía García Ordoñez, Intensivist
        • Sub-Investigator:
          • Emilio Robles-Musso Castillo, Intensivist
        • Sub-Investigator:
          • Miguel Angel Fernández Ibáñez, Intensivist
        • Sub-Investigator:
          • Francisco Javier Vasserot Vargas, Intensivist
      • Ferrol, Madrid, Spain, 28015
        • Recruiting
        • Hospital Arquitecto Marcide
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fernando Garcia Lopez, Cardiology
        • Sub-Investigator:
          • Emiliano Fernandez/Obama Windscheid, Cardiology
      • Galdakao, Madrid, Spain, 28015
        • Recruiting
        • Hospital de Galdakano
        • Contact:
        • Contact:
        • Principal Investigator:
          • Javier Zumalde Otegui, Cardiology
        • Sub-Investigator:
          • Alaitz Romero, Cardiology
        • Sub-Investigator:
          • German Zugazabeitia, Cardiology
      • Orense, Madrid, Spain, 28015
        • Recruiting
        • Hospital de Orense
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marcos Antonio Perez Veloso, Cardiology
        • Sub-Investigator:
          • Beariz Gonzalez Chana, Cardiology
      • Oviedo, Madrid, Spain, 28015
        • Recruiting
        • Hospital General De Asturias
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jose Manuel Rubin Lopez, Cardiology
        • Sub-Investigator:
          • Daniel Garcia Iglesias, Cardiology
        • Sub-Investigator:
          • Diego Perez Diez, Cardiology
        • Sub-Investigator:
          • David Calvo Cuervo, Cardiology
      • Plasencia, Madrid, Spain, 28015
        • Not yet recruiting
        • Hospital Virgen Del Puerto
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Rodriguez Palomo, Cardiology
      • Puerto Real, Madrid, Spain, 28015
        • Recruiting
        • Hospital de Puerto Real
        • Contact:
        • Contact:
        • Principal Investigator:
          • Francisco Javier Lozano Cid, Cardiology
        • Sub-Investigator:
          • Pablo Jose Gonzalez Perez, Cardiology
      • Sabadell, Madrid, Spain, 28015
        • Recruiting
        • Hospital Parc Taul'i
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gabriel Gusi Tragant, Cardiologist
        • Sub-Investigator:
          • Jordi Puntí Sala, Cardiologist
        • Sub-Investigator:
          • Antoni Martínez Rubio, Cardiologist
        • Sub-Investigator:
          • Jesus Ignaci Juménez Lopez, Cardiologist
      • Santander, Madrid, Spain, 28015
        • Recruiting
        • Hospital Marques de Valdecilla
        • Contact:
        • Contact:
        • Principal Investigator:
          • Juan Jose Olalla, Cardiology
        • Sub-Investigator:
          • Susana Gonzalez, Cardiology
      • Valladolid, Madrid, Spain, 28015
        • Recruiting
        • Hospital Rio Hortega
        • Contact:
        • Contact:
        • Principal Investigator:
          • Benito Herreros, Cardiology
        • Sub-Investigator:
          • Sergio Madero, Cardiology
      • Vitoria, Madrid, Spain, 28015
        • Recruiting
        • Hospital Universitatis de Araba
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maria Robledo Iniarritu, Cardiology
        • Sub-Investigator:
          • Jon Orruño, Cardiology
        • Sub-Investigator:
          • Santiago Garcia Mancebo, Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Population with an accepted indication of an implantable cardiac device, including pacemakers, defibrillators and cardiac resynchronizers

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients with implantable cardiac devices that require a diagnostic test based on MRI
Time Frame: 1 year
statistical analysis of the variable
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary indication for MRI
Time Frame: 1 year
statistical analysis of the variable
1 year
Reasons for not used MRI
Time Frame: 1 year
statistical analysis of the variable
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
Time Frame: 1 year
statistical analysis of the variable
1 year
Cost effectiveness of the he MRI Autodetect function
Time Frame: 1 year
statistical analysis of the variable
1 year
Analysis of the differences in the workflow
Time Frame: 1 year
statistical analysis of the variable
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trialance SCCL

Investigators

  • Principal Investigator: Francisco Javier Alzueta, MD, PhD, Hospital Virgen de la Victoria
  • Principal Investigator: Francisco Ruiz Mateas, MD, PhD, Hospital Costa del Sol

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2017

Primary Completion (Anticipated)

June 30, 2020

Study Completion (Anticipated)

July 30, 2020

Study Registration Dates

First Submitted

December 9, 2019

First Submitted That Met QC Criteria

March 30, 2020

First Posted (Actual)

April 2, 2020

Study Record Updates

Last Update Posted (Actual)

April 14, 2020

Last Update Submitted That Met QC Criteria

April 12, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RMN01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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