Magnetic Field ExposurePROMeNADeNCT03081364
Patient Registry Of Magnetic Resonance Imaging in Non-Approved DEvices
An observational study of Magnetic Field Exposure, run by Saint Luke's Health System.
Trial summary
The investigators are providing MRI in patients with non-MRI approved CIED's (Cardiac Implanted Electronic Devices) Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Magnetic Field Exposure
- What is being tested?
- Initiate ACLS protocol if lethal arrythmia develops
- How many people
- 532 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Sep 2022
- How long will I take part?
- 1 Month
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: For all patients in whom a clinical MRI examination is felt to be important in the patients care, and in whom the potential benefits clearly outweigh the risks of an MRI exam as referred from various primary and/or subspecialty physicians.
Who may be able to join
- Anyone with a cardiac device
Who cannot join
- Anyone who cannot consent for themselves or who don't have a durable power of attorney
About this study
The investigators are providing MRI in patients with non-MRI approved CIED's (Cardiac Implanted Electronic Devices)
Read the detailed description
At Saint Luke's Hospital, despite growing evidence to the contrary, there is extremely limited data and experience with performing MRIs on patient with abandoned and epicardial leads in patients with non-approved ICDs and PMs. There is a limited mechanism to discuss this issue with the patient, screen the patient and assess their device beforehand, monitor them during the MRI examination, keep track of pulse sequences used, assess their devices after (and if necessary, resume prior programming before any changes), and to maintain that experience. The objective of this study is to create a protocol for an MRI at the commonly used magnetic strength of 1.5 T in patients that do not have conditional pacemakers and/or defibrillators and have abandoned or epicardial leads and maintain a registry of participants, devices involved, MRI examinations and pulse sequences used, and to keep records of any follow up events.
- Conditions
- Magnetic Field Exposure
- Being tested
- Initiate ACLS protocol if lethal arrythmia develops
- Keywords
- Cardiac Implanted Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initiate ACLS protocol if lethal arrythmia developsOther
Cardiac Rhythm Management
| Study group | Role | What they receive |
|---|---|---|
| Outpatients | MRI; Critical Care Monitoring, Device Programming Receives: Other: Initiate ACLS protocol if lethal arrythmia develops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Device Function
Change in lead impedance or sensing
Measured: 3 years
Change in Thresholds of Pacing Lead
Measured in mA
Measured: 3 years
Dysrhythmias Noted During Scan
Change in heart rhythm
Measured: 3 years
Oxygen Saturation
Percentage of change or no change
Measured: 3 years
Change in heart rate
Measured as beats per minute on single-lead heart monitor.
Measured: 3 years
Patient Comments
Real-time patient report via intercom during scan of chest symptoms such as burning or aching
Measured: 3 years
Interference Between the Implanted Cardiac Electronic Device and MRI
Measure any change in device battery voltage
Measured: 3 years
Change in blood pressure
Monitored with automatic blood pressure cuff
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2017
- Study startSep 2015
- Primary completionSep 2022
- Study completionSep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Magnetic Field ExposureStudies 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
- 532 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Saint Luke's Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanjaya K Gupta, MD, Principal investigator, St. Luke's Hospital, Kansas City, Missouri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03081364
- Sponsor's protocol ID
- 15-335
- Acronym
- PROMeNADe
- Status last verified
- Jun 2023
- First submitted
- 4 Jan 2017
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share the IPD
Publications
Gupta SK, Ya'qoub L, Wimmer AP, Fisher S, Saeed IM. Safety and Clinical Impact of MRI in Patients with Non-MRI-conditional Cardiac Devices. Radiol Cardiothorac Imaging. 2020 Oct 22;2(5):e200086. doi: 10.1148/ryct.2020200086. eCollection 2020 Oct.
PubMed 33778621
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Registry Of Magnetic Resonance Imaging in Non-Approved DEvices
- ClinicalTrials.gov ID
- NCT03081364
- Acronym / sponsor ID
- PROMeNADe / 15-335
- Conditions
- Magnetic Field Exposure
- Keywords
- Cardiac Implanted Device
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 532 participants (actual)
- Lead sponsor
- Saint Luke's Health SystemUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Sep 2022 (actual)
- Study completion
- Sep 2022 (actual)
- First posted
- 16 Mar 2017 (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 investigators are providing MRI in patients with non-MRI approved CIED's (Cardiac Implanted Electronic Devices)
Detailed description
At Saint Luke's Hospital, despite growing evidence to the contrary, there is extremely limited data and experience with performing MRIs on patient with abandoned and epicardial leads in patients with non-approved ICDs and PMs. There is a limited mechanism to discuss this issue with the patient, screen the patient and assess their device beforehand, monitor them during the MRI examination, keep track of pulse sequences used, assess their devices after (and if necessary, resume prior programming before any changes), and to maintain that experience. The objective of this study is to create a protocol for an MRI at the commonly used magnetic strength of 1.5 T in patients that do not have conditional pacemakers and/or defibrillators and have abandoned or epicardial leads and maintain a registry of participants, devices involved, MRI examinations and pulse sequences used, and to keep records of any follow up events.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Outpatients | – | Other: Initiate ACLS protocol if lethal arrythmia developsMRI; Critical Care Monitoring, Device Programming |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- For all patients in whom a clinical MRI examination is felt to be important in the patients care, and in whom the potential benefits clearly outweigh the risks of an MRI exam as referred from various primary and/or subspecialty physicians.
Key inclusion criteria (1 listed)
- Anyone with a cardiac device
Key exclusion criteria (1 listed)
- Anyone who cannot consent for themselves or who don't have a durable power of attorney
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 |
|---|---|---|
| Initiate ACLS protocol if lethal arrythmia developsCardiac Rhythm Management | Other | Outpatients |
Primary outcome
Change in Device Function
Time frame: 3 years
Change in lead impedance or sensing
Change in Thresholds of Pacing Lead
Time frame: 3 years
Measured in mA
Dysrhythmias Noted During Scan
Time frame: 3 years
Change in heart rhythm
Oxygen Saturation
Time frame: 3 years
Percentage of change or no change
Change in heart rate
Time frame: 3 years
Measured as beats per minute on single-lead heart monitor.
Patient Comments
Time frame: 3 years
Real-time patient report via intercom during scan of chest symptoms such as burning or aching
Interference Between the Implanted Cardiac Electronic Device and MRI
Time frame: 3 years
Measure any change in device battery voltage
Change in blood pressure
Time frame: 3 years
Monitored with automatic blood pressure cuff
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 12 Jun 2023.
- Derived from this study: PubMed 33778621Gupta SK, Ya'qoub L, Wimmer AP, Fisher S, Saeed IM. Safety and Clinical Impact of MRI in Patients with Non-MRI-conditional Cardiac Devices. Radiol Cardiothorac Imaging. 2020 Oct 22;2(5):e200086. doi: 10.1148/ryct.2020200086. eCollection 2020 Oct.
- Individual participant dataSharing planned: No. There is no plan to share the IPD
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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.
Sanjaya K Gupta, MD principal investigator
St. Luke's Hospital, Kansas City, Missouri
Questions about this trial
What is this clinical trial studying?
An observational study of Magnetic Field Exposure, run by Saint Luke's Health System.
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 1 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 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in Device Function (time frame: 3 years). The study lists 8 primary outcomes in all. 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 NCT03081364, which also lists 1 linked publication.
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 12 Jun 2023.