Implantable Cardiac Device. Patients With a NMR IndicationRESONANCENCT04330898
Patients With Implantable Cardiac Devices Requiring a Nuclear Magnetic Resonance
An observational study of Implantable Cardiac Device. Patients With a NMR Indication, run by Trialance SCCL at 20 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Implantable Cardiac Device. Patients With a NMR Indication
- What is being tested?
- Biotronik peacemakers, implantable cardioverter-defibrillators and cardiac resynchronizers
- Type of treatment
- Medical device
- How many people
- 1,248 participants
- Where
- 20 sitesSpain
- Study dates
- 2 May 2017to 30 Jul 2020
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population with an accepted indication of an implantable cardiac device, including pacemakers, defibrillators and cardiac resynchronizers
Who may be able to join
- Patients carrying a cardiac stimulation device
- Patients able to understand the nature of the procedure
- Patients who give informed consent
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Spain20 sites, 20 recruiting
- Recruiting
Hospital General de Alicante
Alicante
Concetta Chirico, PharmTechD, +34645494281, cchirico@trialance.com
Marta Barbacid Hernández, PhrmD, MSc, +34630767668, mbarbacid@trialance.com
- Recruiting
Hospital San Juan de Alicante
Alicante
Concetta Chirico, PharmTechD, +34645494281, cchirico@trialance.com
Marta Barbacid Hernández, PharmD,MSc, +34630767668, mbarbacid@trialance.com
- Recruiting
Hospital de Cruces
Barakaldo
Marta Barbacid Hernández, PharmD, MSc, +34630767668, mbarbacid@trialance.com
Concetta Chirico, PhamTechD, +34645494281, cchirico@trialance.com
- Recruiting
Hospital Clinic
Barcelona
Concetta Chirico, PharmTechD, +34645494281, cchirico@trialance.com
Marta Barbacid Hernández, PharmD, MSc, +34630767668, mbarbacid@trialance.com
- Recruiting
Hospital de Bellvitge
Barcelona
Concetta Chirico, PharmTechD, +34645494281, cchirico@trialance.com
Marta Barbacid Hernández, PharmD, MSc, +34630767668, mbarbacid@trialance.com
- Recruiting
Hospital San Pedro de Alcantara
Cáceres, Madrid, 28015
Marta Barbacid Hernández, PharmD, MSc, +34630767668, mbarbacid@trialance.com
Concetta Chirico, PharmTechD, +34645494281, cchirico@trialance.com
- Recruiting
Hospital de Poniente
El Ejido, Madrid, 28015
Marta B Barbacid Hernández, PharmD, MSc, +34630767668, mbarbacid@trialance.com
Concetta Chirico, PharmTechD, +34645494281, cchirico@trialance.com
- Recruiting
Hospital Arquitecto Marcide
Ferrol, Madrid, 28015
Marta Barbacid Hernández, PharmD, MSc, +34630767668, mbarbacid@trialance.com
Concetta Chirico, PharmTechD, +34645494281, cchirico@trialance.com
- Recruiting
Hospital de Galdakano
Galdakao, Madrid, 28015
Marta Barbacid Hernández, PharmD, MSc, +34630767668, mbarbacid@trialance.com
Concetta B Chirico, PharmD, MSc, +34645494281, cchirico@trilance.com
- Recruiting
Hospital Puerta de Hierro
Madrid
Marta Barbacid Hernández, PharmD, MSc, +34630767668, mbarbacid@trialance.com
Concetta Chirirco, PharmTechD, +34645494281, cchirico@trialance.com
- Recruiting
Hospital Virgen de la Victoria
Málaga
Concetta Chirico, PharmTechD, +34 645494281, cchirico@trialance.com
Marta Barbacid, PharmD, MSc, +34 630767668, mbarbacid@trialance.com
- Recruiting
Hospital Costa del Sol
Marbella
Concetta Chirico, PharmTechD, +34645494281, cchirico@trialance.com
Marta Barbacid Hernández, PharmD, MSc, +34630767668, mbarbacid@trialance.com
- Recruiting
Hospital de Orense
Orense, Madrid, 28015
Marta Barbacid Hernández, PharmD, MSc, +34630767668, mbarbacid@trialance.com
Concetta Chirico, PharmTechD, +34645494281, cchirico@trialance.com
- Recruiting
Hospital General de Asturias
Oviedo, Madrid, 28015
Marta Barbacid Hernández, PharmD, MSc, +34630767668, mbarbacid@trialance.com
Concetta Chirico, PharmTechD, +34645494281, cchirico@trialance.com
- Not yet recruiting
Hospital Virgen del Puerto
Plasencia, Madrid, 28015
Marta Barbacid Hernández, PharmD, MSc, +34630767668, mbarbacid@trialance.com
Concetta Chirico, PharmTechD, +34645494281, cchirico@trialance.com
- Recruiting
Hospital de Puerto Real
Puerto Real, Madrid, 28015
Marta Barbacid Hernández, ParmD, MSc, +34630767668, mbarbacid@trialance.com
Concetta Chirico, PharmTechD, +34645494281, cchirico@trialance.com
- Recruiting
Hospital Parc Taul'i
Sabadell, Madrid, 28015
Marta B Barbacid Hernández, PharmD, MSc, +34630767668, mbarbacid@trialance.com
Concetta Chirico, PharmTechD, +34645494281, cchirico@trialance.com
- Recruiting
Hospital Marques de Valdecilla
Santander, Madrid, 28015
Marta Barbacid Hernández, PharmD, MSc, +34630767668, mbarbacid@trialance.com
Concetta Chirico, PharmTechD, +34645494981cchiric, cchirico@trialance.com
- Recruiting
Hospital Rio Hortega
Valladolid, Madrid, 28015
Marta Barbacid Hernández, PharmD, MSc, +34630767668, mbarbacid@trialance.com
Concetta Chirico, PharmTechD, +34645494281, cchirico@trialance.com
- Recruiting
Hospital Universitatis de Araba
Vitoria, Madrid, 28015
Marta Barbacid Hernández, PharmD, MSc, +34630767668, mbarbacid@trialance.com
Concetta Chirico, PharmTechD, +34645494281, cchirico@trialance.com
About this study
Official title: 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.
Read the 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
- Being tested
- Biotronik peacemakers, implantable cardioverter-defibrillators and cardiac resynchronizers
- Keywords
- Peacemaker, implantable cardioverter-defibrillator, Nuclear Magnetic Resonance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biotronik peacemakers, implantable cardioverter-defibrillators and cardiac resynchronizersDevice
Any of these Biotronik cardiac stimulation devices with the Home Monitoring function activated for the remote control of patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with implantable cardiac devices that require a diagnostic test based on MRI
statistical analysis of the variable
Measured: 1 year
Secondary outcomes (5)
Primary indication for MRI
statistical analysis of the variable
Measured: 1 year
Reasons for not used MRI
statistical analysis of the variable
Measured: 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
Measured: 1 year
Cost effectiveness of the he MRI Autodetect function
statistical analysis of the variable
Measured: 1 year
Analysis of the differences in the workflow
statistical analysis of the variable
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start2 May 2017
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Implantable Cardiac Device. Patients With a NMR IndicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,248 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Trialance SCCL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francisco Javier Alzueta, MD, PhD, Principal investigator, Hospital Virgen de la VictoriaFrancisco Ruiz Mateas, MD, PhD, Principal investigator, Hospital Costa del Sol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04330898
- Sponsor's protocol ID
- RMN01
- Acronym
- RESONANCE
- Status last verified
- Apr 2020
- First submitted
- 9 Dec 2019
- Last updated
- 14 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 17030942Durack 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.
PubMed 8154507Kanal 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.
PubMed 15100103Gold 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.
PubMed 25982014
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spanish Registry of Patients With Implantable Cardiac Devices That Require a Diagnostic Imaging Test With Nuclear Magnetic Resonance
- ClinicalTrials.gov ID
- NCT04330898
- Acronym / sponsor ID
- RESONANCE / RMN01
- Keywords
- Peacemaker, implantable cardioverter-defibrillator, Nuclear Magnetic Resonance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,248 participants (estimated)
- Lead sponsor
- Trialance SCCLIndustry (pharma, biotech, devices)
- Study start
- 2 May 2017 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Jul 2020 (estimated)
- First posted
- 2 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population with an accepted indication of an implantable cardiac device, including pacemakers, defibrillators and cardiac resynchronizers
Key inclusion criteria (3 listed)
- Patients carrying a cardiac stimulation device
- Patients able to understand the nature of the procedure
- Patients who give informed consent
Key exclusion criteria (9 listed)
- Epicardial cables
- Abandoned cables
- Non-BIOTRONIK cables
- Age <18 years
- Pregnant and breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biotronik peacemakers, implantable cardioverter-defibrillators and cardiac resynchronizersAny of these Biotronik cardiac stimulation devices with the Home Monitoring function activated for the remote control of patients | Device | – |
Primary outcome
Percentage of patients with implantable cardiac devices that require a diagnostic test based on MRI
Time frame: 1 year
statistical analysis of the variable
5 secondary outcomes
Primary indication for MRI
Time frame: 1 year
Reasons for not used MRI
Time frame: 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
Cost effectiveness of the he MRI Autodetect function
Time frame: 1 year
Analysis of the differences in the workflow
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Background: PubMed 17030942Marcu 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.
- Background: PubMed 8154507Durack 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.
- Background: PubMed 15100103Kanal 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.
- Results publication: PubMed 25982014Gold 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco Javier Alzueta, MD, PhD principal investigator
Hospital Virgen de la Victoria
Francisco Ruiz Mateas, MD, PhD principal investigator
Hospital Costa del Sol
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Implantable Cardiac Device. Patients With a NMR Indication, run by Trialance SCCL at 20 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xavier Molina Figueras, PharmD, PhD (+ 34 689900009, xmolina@trialance.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with implantable cardiac devices that require a diagnostic test based on MRI (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04330898, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020.