Magnetic Resonance ImagingNCT02357082
Mayo Clinic Cardiac Implantable Electronic Device MRI Registry
An observational study of Magnetic Resonance Imaging, run by Mayo Clinic at 1 site in United States.
Trial summary
Registry intends to prospectively collect data regarding the safety of magnetic resonance imaging (MRI) studies in patients with cardiac pacemakers on implantable cardioverter defibrillators. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Magnetic Resonance Imaging
- What is being tested?
- MRI Scan
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to 20 Apr 2022
- How long will I take part?
- 6 Months
- 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: Patients at Mayo Clinic who have a previously implanted CIED and are scheduled for a clinically-indicated MRI will be included in the registry.
Who may be able to join
- Strong clinical indication for MRI; in the clinical setting where MRI is the diagnostic modality of choice for a specific disease state without acceptable alternative imaging technology
- Male or Female
- 18 years of age or older
- Able to provide informed consent
- Presence of CIED
Who cannot join
- Presence of metallic objects that represent a contraindication to MR imaging, including: MRI-unsafe intra-orbital or intra-ocular retained metal fragments, and MRI-unsafe intracranial vascular clips and coils, other MRI-unsafe devices
- Morbid obesity (abdominal diameter greater than 60 centimeters) which results in contact wiht the magnet bore.
- Pregnant at time of scanning Pacemaker or Implanted Cardiac Device that is labeled as MRI-Conditional (approved by the Food and Drug Administration for exposure to MRI)
- Pacemaker dependent and either: 1) device implanted before 2005, or 2) advisory pulse generator that may lower outputs in the setting of radiofrequency currents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mayo Clinic Cardiac Implantable Electronic Device (CIED) Magnetic Resonance Imaging (MRI) Registry; Determining the Risks of of MRI in the Presence of Cardiac Implantable Electronic Devices
Registry intends to prospectively collect data regarding the safety of magnetic resonance imaging (MRI) studies in patients with cardiac pacemakers on implantable cardioverter defibrillators.
- Conditions
- Magnetic Resonance Imaging
- Being tested
- MRI Scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI ScanRadiation
Also called Magnetic Resonance Imaging
MRI scan with Specific Absorption Rate (SAR) limit of 1.5 watts per kilogram of body weight
| Study group | Role | What they receive |
|---|---|---|
| MRI Scan | Patients with a previously implanted Cardiac Implantable Electronic Device who are undergoing an MRI Scan for clinically indicated, diagnostic purposes. Receives: Radiation: MRI Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Implantable Electronic Device Lead Impedance at Different Timepoints
Measured: Baseline, Visit 1, 3 months, 6 months
Cardiac Implantable Electronic Device Lead Threshold at Different Timepoints
Measured: Baseline, Visit 1, 3 months, 6 months
P/R Wave Amplitude at Different Timepoints
Measured: Baseline, Visit 1, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study startDec 2016
- Primary completion20 Apr 2022
- Study completion20 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Magnetic Resonance ImagingStudies 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
- 1,000 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert E. Watson, Mayo Clinic
- Investigators
- Paul A Friedman, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02357082
- Sponsor's protocol ID
- 14-001925
- Status last verified
- Jun 2022
- First submitted
- 20 Jan 2015
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mayo Clinic Cardiac Implantable Electronic Device (CIED) Magnetic Resonance Imaging (MRI) Registry; Determining the Risks of of MRI in the Presence of Cardiac Implantable Electronic Devices
- ClinicalTrials.gov ID
- NCT02357082
- Acronym / sponsor ID
- 14-001925
- Conditions
- Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- 20 Apr 2022 (actual)
- Study completion
- 20 Apr 2022 (actual)
- First posted
- 6 Feb 2015 (estimated)
- 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.
Registry intends to prospectively collect data regarding the safety of magnetic resonance imaging (MRI) studies in patients with cardiac pacemakers on implantable cardioverter defibrillators.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI Scan | – | Radiation: MRI ScanPatients with a previously implanted Cardiac Implantable Electronic Device 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
- Patients at Mayo Clinic who have a previously implanted CIED and are scheduled for a clinically-indicated MRI will be included in the registry.
Key inclusion criteria (5 listed)
- Strong clinical indication for MRI; in the clinical setting where MRI is the diagnostic modality of choice for a specific disease state without acceptable alternative imaging technology
- Male or Female
- 18 years of age or older
- Able to provide informed consent
- Presence of CIED
Key exclusion criteria (4 listed)
- Presence of metallic objects that represent a contraindication to MR imaging, including: MRI-unsafe intra-orbital or intra-ocular retained metal fragments, and MRI-unsafe intracranial vascular clips and coils, other MRI-unsafe devices
- Morbid obesity (abdominal diameter greater than 60 centimeters) which results in contact wiht the magnet bore.
- Pregnant at time of scanning Pacemaker or Implanted Cardiac Device that is labeled as MRI-Conditional (approved by the Food and Drug Administration for exposure to MRI)
- Pacemaker dependent and either: 1) device implanted before 2005, or 2) advisory pulse generator that may lower outputs in the setting of radiofrequency currents
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 |
|---|---|---|
| MRI ScanAlso: Magnetic Resonance ImagingMRI scan with Specific Absorption Rate (SAR) limit of 1.5 watts per kilogram of body weight | Radiation | MRI Scan |
Primary outcome
Cardiac Implantable Electronic Device Lead Impedance at Different Timepoints
Time frame: Baseline, Visit 1, 3 months, 6 months
Cardiac Implantable Electronic Device Lead Threshold at Different Timepoints
Time frame: Baseline, Visit 1, 3 months, 6 months
P/R Wave Amplitude at Different Timepoints
Time frame: Baseline, Visit 1, 3 months, 6 months
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 10 Jun 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.
Paul A Friedman, 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, 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 5 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 10 Jun 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?
Cardiac Implantable Electronic Device Lead Impedance at Different Timepoints (time frame: Baseline, Visit 1, 3 months, 6 months). The study lists 3 primary outcomes in all. 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 10 Jun 2022.