Magnetic Resonance Imaging (MRI)NCT04151953
Myocardial Injury in Patients With Cardiac Implantable Electronic Devices Following Magnetic Resonance Imaging
An observational study of Magnetic Resonance Imaging (MRI), run by Mayo Clinic at 1 site in United States.
Trial summary
Researchers are trying to determine if heart injury occurs in subjects with cardiac implantable electronic device (CIED), such as a pacemaker or implantable cardioverter defibrillator (ICD), who undergo a magnetic resonance imaging (MRI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Magnetic Resonance Imaging (MRI)
- What is being tested?
- Blood sample collection
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2019to 1 Dec 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult males and females age 18 and above identified from the electronic medical record (EMR) calendar of patients with devices who are coming for a MRI
Who may be able to join
- Patients who have CIED devices (whether conditional or unconditional, regardless of the type of device e.g. ICD, pacemakers, leadless pacemakers) who undergo MRI for any reason
Who cannot join
- Patients under age 18
- Patients with myocardial infarction, coronary artery bypass grafting or any invasive cardiac procedure in the previous six weeks
- Pregnant patients
- Patients who cannot provide informed consent because of cognitive dysfunction
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Evaluation of Potential Myocardial Injury in Patients With Cardiac Implantable Electronic Devices Following Magnetic Resonance Imaging
Researchers are trying to determine if heart injury occurs in subjects with cardiac implantable electronic device (CIED), such as a pacemaker or implantable cardioverter defibrillator (ICD), who undergo a magnetic resonance imaging (MRI).
Read the detailed description
With an aging population and growing indications for both MRI and CIEDs, it is estimated that patients with a CIED will have up to a 75% likelihood to meet some indication for MRI during their lifetime. MRI in patients with CIEDs has been increasingly shown to be a viable option in a variety of clinical circumstances under strict protocols and close monitoring. It is uncertain if MRI results in myocardial injury. Injury could occur due to heating of the lead(s) with myocardial heating and injury occurring at the lead tip.
A previous Mayo study published in 2016 showed no significant changes in cardiac troponin levels in the majority of patients with a CIED when MRI was performed. This study however was done using the older, less sensitive troponin assay. Unpublished data from the Mayo ED showed an increase in diagnosis of acute myocardial injury from 39% to 62% after implementation of the new hs-cTnT assay, reflecting its increased sensitivity. The previous Mayo study was also a retrospective study, and thus the data gathered was not as rigorously controlled as might be ideal.
- Conditions
- Magnetic Resonance Imaging (MRI)
- Being tested
- Blood sample collection
- Keywords
- Pacemaker, Implantable Cardioverter Defibrillator (ICD), Cardiac implantable electronic device (CIED)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample collectionDiagnostic test
Blood sample collection for markers of myocardial injury
| Study group | Role | What they receive |
|---|---|---|
| Subjects with cardiac implantable electronic device (CIED) | Subjects with previously implanted cardiac implantable electronic device (CIED) who are undergoing an MRI Scan for clinically indicated, diagnostic purposes. Receives: Diagnostic Test: Blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial injury
Changes in high sensitivity cardiac troponin T (hs-cTnT) or troponin I (hs-cTnI) assay
Measured: Baseline, 6-24 hours post MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start8 Oct 2019
- Primary completion3 Aug 2020
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Magnetic Resonance Imaging (MRI)Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allan S. Jaffe, Mayo Clinic
- Investigators
- Allan S Jaffe, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04151953
- Sponsor's protocol ID
- 19-004286
- Status last verified
- Jan 2022
- First submitted
- 2 Nov 2019
- Last updated
- 5 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Potential Myocardial Injury in Patients With Cardiac Implantable Electronic Devices Following Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT04151953
- Acronym / sponsor ID
- 19-004286
- Conditions
- Magnetic Resonance Imaging (MRI)
- Keywords
- Pacemaker, Implantable Cardioverter Defibrillator (ICD), Cardiac implantable electronic device (CIED)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- 3 Aug 2020 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 5 Nov 2019 (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.
Researchers are trying to determine if heart injury occurs in subjects with cardiac implantable electronic device (CIED), such as a pacemaker or implantable cardioverter defibrillator (ICD), who undergo a magnetic resonance imaging (MRI).
Detailed description
With an aging population and growing indications for both MRI and CIEDs, it is estimated that patients with a CIED will have up to a 75% likelihood to meet some indication for MRI during their lifetime. MRI in patients with CIEDs has been increasingly shown to be a viable option in a variety of clinical circumstances under strict protocols and close monitoring. It is uncertain if MRI results in myocardial injury. Injury could occur due to heating of the lead(s) with myocardial heating and injury occurring at the lead tip.
A previous Mayo study published in 2016 showed no significant changes in cardiac troponin levels in the majority of patients with a CIED when MRI was performed. This study however was done using the older, less sensitive troponin assay. Unpublished data from the Mayo ED showed an increase in diagnosis of acute myocardial injury from 39% to 62% after implementation of the new hs-cTnT assay, reflecting its increased sensitivity. The previous Mayo study was also a retrospective study, and thus the data gathered was not as rigorously controlled as might be ideal.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with cardiac implantable electronic device (CIED) | – | Diagnostic Test: Blood sample collectionSubjects with previously implanted cardiac implantable electronic device (CIED) who are undergoing an MRI Scan for clinically indicated, diagnostic purposes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult males and females age 18 and above identified from the electronic medical record (EMR) calendar of patients with devices who are coming for a MRI
Key inclusion criteria (1 listed)
- Patients who have CIED devices (whether conditional or unconditional, regardless of the type of device e.g. ICD, pacemakers, leadless pacemakers) who undergo MRI for any reason
Key exclusion criteria (4 listed)
- Patients under age 18
- Patients with myocardial infarction, coronary artery bypass grafting or any invasive cardiac procedure in the previous six weeks
- Pregnant patients
- Patients who cannot provide informed consent because of cognitive dysfunction
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 |
|---|---|---|
| Blood sample collectionBlood sample collection for markers of myocardial injury | Diagnostic test | Subjects with cardiac implantable electronic device (CIED) |
Primary outcome
Myocardial injury
Time frame: Baseline, 6-24 hours post MRI
Changes in high sensitivity cardiac troponin T (hs-cTnT) or troponin I (hs-cTnI) assay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Allan S Jaffe, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Magnetic Resonance Imaging (MRI), run by Mayo Clinic at 1 site in United States.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial injury (time frame: Baseline, 6-24 hours post MRI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2022.