Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biotronik peacemakers, implantable cardioverter-defibrillators and cardiac resynchronizers | Device | Any of these Biotronik cardiac stimulation devices with the Home Monitoring function activated for the remote control of patients |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with implantable cardiac devices that require a diagnostic test based on MRI | statistical analysis of the variable | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Primary indication for MRI | statistical analysis of the variable | 1 year |
| Reasons for not used MRI | statistical analysis of the variable |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Population with an accepted indication of an implantable cardiac device, including pacemakers, defibrillators and cardiac resynchronizers
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xavier Molina Figueras, PharmD, PhD | Contact | + 34 689900009 | xmolina@trialance.com | |
| Marta Barbacid Hernández, PharmD, MSc | Contact | +34 630767668 | mbarbacid@trialance.com |
| Name | Affiliation | Role |
|---|---|---|
| Francisco Javier Alzueta, MD, PhD | Hospital Virgen de la Victoria | Principal Investigator |
| Francisco Ruiz Mateas, MD, PhD | Hospital Costa del Sol | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital San Pedro de Alcantara | Recruiting | Cáceres | Madrid | 28015 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17030942 | Background | 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. | |
| 8154507 | Background | Durack 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | statistical analysis of the variable | 1 year |
| Cost effectiveness of the he MRI Autodetect function | statistical analysis of the variable | 1 year |
| Analysis of the differences in the workflow | statistical analysis of the variable | 1 year |
| Hospital de Poniente | Recruiting | El Ejido | Madrid | 28015 | Spain |
|
| Hospital Arquitecto Marcide | Recruiting | Ferrol | Madrid | 28015 | Spain |
|
| Hospital de Galdakano | Recruiting | Galdakao | Madrid | 28015 | Spain |
|
| Hospital de Orense | Recruiting | Orense | Madrid | 28015 | Spain |
|
| Hospital General de Asturias | Recruiting | Oviedo | Madrid | 28015 | Spain |
|
| Hospital Virgen del Puerto | Not yet recruiting | Plasencia | Madrid | 28015 | Spain |
|
| Hospital de Puerto Real | Recruiting | Puerto Real | Madrid | 28015 | Spain |
|
| Hospital Parc Taul'i | Recruiting | Sabadell | Madrid | 28015 | Spain |
|
| Hospital Marques de Valdecilla | Recruiting | Santander | Madrid | 28015 | Spain |
|
| Hospital Rio Hortega | Recruiting | Valladolid | Madrid | 28015 | Spain |
|
| Hospital Universitatis de Araba | Recruiting | Vitoria | Madrid | 28015 | Spain |
|
| Hospital General de Alicante | Recruiting | Alicante | Spain |
|
| Hospital San Juan de Alicante | Recruiting | Alicante | Spain |
|
| Hospital de Cruces | Recruiting | Barakaldo | Spain |
|
| Hospital Clinic | Recruiting | Barcelona | Spain |
|
| Hospital de Bellvitge | Recruiting | Barcelona | Spain |
|
| Hospital Puerta de Hierro | Recruiting | Madrid | Spain |
|
| Hospital Costa del Sol | Recruiting | Marbella | Spain |
|
| Hospital Virgen de la Victoria | Recruiting | Málaga | Spain |
|
| 15100103 | Background | Kanal 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. |
| 25982014 | Result | Gold 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. |
| ID | Term |
|---|---|
| D017147 | Defibrillators, Implantable |
| ID | Term |
|---|---|
| D047548 | Defibrillators |
| D004566 | Electrodes |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D004567 | Electrodes, Implanted |
| D019736 | Prostheses and Implants |
Not provided
Not provided