MRICDMRNCT02548819
University Hospital Cardiac Device MR Registry: The Safety of MR Imaging in Patients With Implanted Cardiac Devices
An observational study of MRI and Pacemaker, run by University Health Care System, Augusta, Georgia at 1 site in United States.
Trial summary
A single-center registry to prospectively evaluate the safety of non-cardiac/non-thoracic magnetic resonance imaging (MRI) in patients with implanted cardiac devices (pacemakers and implantable cardioverter defibrillators). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- MRI, Pacemaker, Defibrillator
- What is being tested?
- MRI
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Mar 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who require MR imaging in the presence of a pacemaker or ICD
Who may be able to join
- Male or female 18 years or older
- Informed consent can be provided by patient or medical power of attorney
- Presence of implanted pacemaker or ICD
- MRI is the diagnostic modality of choice for a specific clinical scenario without acceptable alternative imaging technology as determined by ordering physician
- Non-cardiac/non-thoracic MRI ordered
Who cannot join
- Presence of metallic objects that represent a contraindication to MR imaging
- Morbid obesity which results in body contact with the magnet façade
- Pacemaker or ICD generator implanted prior to 2002
- ICD patients who are pacing dependent
- Pregnancy
- Device generator at ERI (elective replacement interval)
Show all 11Show fewer
- Presence of other active implanted medical device
- Presence of abandoned leads (with the exception of post CABG temporary epicardial pacing wires)
- Presence of implanted cardiac device in the abdominal position
- Pacemaker or ICD that is labeled as MRI-Conditional by the FDA
- Pacemaker or ICD implanted less than 6 weeks prior to MRI scan
Trial locations and contacts
1 site in 1 country.
About this study
A single-center registry to prospectively evaluate the safety of non-cardiac/non-thoracic magnetic resonance imaging (MRI) in patients with implanted cardiac devices (pacemakers and implantable cardioverter defibrillators).
Read the detailed description
Evaluation of safety of MR scanning of patients with implanted cardiac devices. Device parameters pre and post MR imaging will be assessed.
- Conditions
- MRI, Pacemaker, Defibrillator
- Being tested
- MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
MR imaging of patients with implanted cardiac devices
What is being measured
The primary outcome is the main question the study is designed to answer.
Battery voltage
Change in voltage > 0.04 V
Measured: Immediate
Pacing lead impedance
Change in impedance > 50 Ohms
Measured: Immediate
Shock impedance
Change in impedance > 3 Ohms
Measured: Immediate
P wave amplitude
Decrease in amplitude > 50%
Measured: Immediate
R wave amplitude
Decrease in amplitude > 25%
Measured: Immediate
Pacing lead threshold
Threshold increase > 0.5 V at a fixed pulse width of 0.4ms
Measured: Immediate
Adverse event
An adverse clinical event
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MRIStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 220 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University Health Care System, Augusta, Georgia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Aquilina, University Health Care System, Augusta, Georgia
- Investigators
- Patrick M Aquilina, MD, Principal investigator, University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02548819
- Sponsor's protocol ID
- IORG0000351
- Acronym
- CDMR
- Status last verified
- May 2017
- First submitted
- 9 Sep 2015
- Last updated
- 1 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- University Hospital Cardiac Device MR Registry: The Safety of MR Imaging in Patients With Implanted Cardiac Devices
- ClinicalTrials.gov ID
- NCT02548819
- Acronym / sponsor ID
- CDMR / IORG0000351
- Conditions
- MRI, Pacemaker, Defibrillator
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- University Health Care System, Augusta, GeorgiaUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 14 Sep 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.
A single-center registry to prospectively evaluate the safety of non-cardiac/non-thoracic magnetic resonance imaging (MRI) in patients with implanted cardiac devices (pacemakers and implantable cardioverter defibrillators).
Detailed description
Evaluation of safety of MR scanning of patients with implanted cardiac devices. Device parameters pre and post MR imaging will be assessed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who require MR imaging in the presence of a pacemaker or ICD
Key inclusion criteria (5 listed)
- Male or female 18 years or older
- Informed consent can be provided by patient or medical power of attorney
- Presence of implanted pacemaker or ICD
- MRI is the diagnostic modality of choice for a specific clinical scenario without acceptable alternative imaging technology as determined by ordering physician
- Non-cardiac/non-thoracic MRI ordered
Key exclusion criteria (11 listed)
- Presence of metallic objects that represent a contraindication to MR imaging
- Morbid obesity which results in body contact with the magnet façade
- Pacemaker or ICD generator implanted prior to 2002
- ICD patients who are pacing dependent
- Pregnancy
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 |
|---|---|---|
| MRIMR imaging of patients with implanted cardiac devices | Other | – |
Primary outcome
Battery voltage
Time frame: Immediate
Change in voltage > 0.04 V
Pacing lead impedance
Time frame: Immediate
Change in impedance > 50 Ohms
Shock impedance
Time frame: Immediate
Change in impedance > 3 Ohms
P wave amplitude
Time frame: Immediate
Decrease in amplitude > 50%
R wave amplitude
Time frame: Immediate
Decrease in amplitude > 25%
Pacing lead threshold
Time frame: Immediate
Threshold increase > 0.5 V at a fixed pulse width of 0.4ms
Adverse event
Time frame: Immediate
An adverse clinical event
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 1 Jun 2017.
- Individual participant dataSharing planned: No
Related trials for MRI
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
Not yet recruitingObservational study
Multidimensional Study Designed to Develop a Methodological Framework Based on MRI Data to Predict Pathological Complete Response (pCR) in Patients With Locally Advanced Rectal Cancer After Neoadjuvant Treatment
Rectal Cancer, Chemoradiotherapy
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
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.
Patrick M Aquilina, MD principal investigator
University Hospital
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 MRI and Pacemaker, run by University Health Care System, Augusta, Georgia 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 11 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 1 Jun 2017. 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?
Battery voltage (time frame: Immediate). The study lists 7 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 1 Jun 2017.