PacemakerPM/ICDNCT02513056
Study Evaluating the Use of MRI on CMS Patients
An observational study of Pacemaker and Implantable Cardioverter Defibrillators, run by University of Pennsylvania at 1 site in United States.
Trial summary
The overall objective of this protocol is to evaluate the safety and utility of diagnostic MRI in Center for Medicare and Medicaid Services (CMS) beneficiaries with pacemakers and Implantable Cardioverter Defibrillators (ICD) and clinical need for MRI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pacemaker, Implantable Cardioverter Defibrillators
- What is being tested?
- MRI
- How many people
- 872 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2015to 1 Feb 2022
- How long will I take part?
- 6 Weeks
- 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 with pacemakers and/or implantable cardioverter defibrillators (ICD) referred for an outpatient Magnetic Resonance Imaging (MRI) procedure.
Who may be able to join
- Patients are at least 18 years of age
- Patients have a medically/clinically indicated need for an MRI as an outpatient
- Patients with a non-MRI conditional pacemaker and/or ICD implanted after the year 2000
- Patients are CMS beneficiaries
- Patients are willing and able to sign consent and HIPAA authorization or is authorized to sign consent for subject.
Who cannot join
- Other contraindications to MRI
- Pacemaker or ICD implanted prior to the year 2000
- Patient is unwilling/unable to sign consent and HIPAA authorization
- Leads and/or generator implanted within 6 weeks of the proposed MRI
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Prospective Observational Study Evaluating the Use of MRI on CMS Beneficiaries With Non-Conditional Pacemakers and/or Implantable Cardioverter Defibrillators
The overall objective of this protocol is to evaluate the safety and utility of diagnostic MRI in Center for Medicare and Medicaid Services (CMS) beneficiaries with pacemakers and Implantable Cardioverter Defibrillators (ICD) and clinical need for MRI.
Read the detailed description
A referring physician will request an outpatient MRI in an implanted device patient through an order placed in the electronic ordering system, over the telephone to the MRI scheduling office, or by directly contacting a radiologist or MRI technologist. Upon receiving such a request, the referring physician will be sent a copy of the attached screening form, which is used for all implanted device patients. The form includes instructions for obtaining approval for the study and space for documenting ordering physician, study indication, and information about the patient's implanted device (if their device is not followed by a UPHS physician). For CMS beneficiaries, an addition to the form will discuss the clinical trial and ask the referring physician how the results of the MRI will change patient treatment or prognosis and what would be done were an MRI not available. The approval of an attending radiologist in the radiology section that will be interpreting the study (e.g. neuroradiology for brain MRI, cardiovascular imaging for cardiac MRI) is required.
Once the patient is deemed eligible and consented, the study staff will enter the patient into the registry as well as register them onto the trial through PennChart.
- Conditions
- Pacemaker, Implantable Cardioverter Defibrillators
- Being tested
- MRI
- Keywords
- non-conditional pacemakers, implantable cardioverter defibrillator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
MRI
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician decision making
The primary measure of this study is physician decision making. Referring physicians will be asked about the effect of the MRI clinical management strategy, planning of treatments and interventions, as well as if/how the MRI results prevented other diagnostic studies or interventions, and other exposures (such as to ionizing radiation or iodinated contrast from CT scans). Analysis will be tabulation of how scan would change treatment or prognosis and what would be done if MR not available (based upon referring physician response on the screening form, physician and how the physicians believe that having the MRI will impact the treatment and quality of life by completing the QOL form.
Measured: 4 years
Secondary outcomes (1)
Adverse Events
Adverse events related to the MRI scan will be recorded and reviewed. AE's will be reviewed based on the criteria set forth in the protocol. AEs will be documented on an AE form and AE log and then entered into a redcap database.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2015 (estimated)
- Study start17 Aug 2015
- Primary completionDec 2019
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PacemakerStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 872 participants (actual)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mitchell Schnall, MD, PhD, Study chair, University of PennsylvaniaHarold Litt, MD, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02513056
- Sponsor's protocol ID
- 821487
- Acronym
- PM/ICD
- Status last verified
- May 2024
- First submitted
- 8 Dec 2014
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study Evaluating the Use of MRI on CMS Beneficiaries With Non-Conditional Pacemakers and/or Implantable Cardioverter Defibrillators
- ClinicalTrials.gov ID
- NCT02513056
- Acronym / sponsor ID
- PM/ICD / 821487
- Conditions
- Pacemaker, Implantable Cardioverter Defibrillators
- Keywords
- non-conditional pacemakers, implantable cardioverter defibrillator
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 872 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 17 Aug 2015 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 31 Jul 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.
The overall objective of this protocol is to evaluate the safety and utility of diagnostic MRI in Center for Medicare and Medicaid Services (CMS) beneficiaries with pacemakers and Implantable Cardioverter Defibrillators (ICD) and clinical need for MRI.
Detailed description
A referring physician will request an outpatient MRI in an implanted device patient through an order placed in the electronic ordering system, over the telephone to the MRI scheduling office, or by directly contacting a radiologist or MRI technologist. Upon receiving such a request, the referring physician will be sent a copy of the attached screening form, which is used for all implanted device patients. The form includes instructions for obtaining approval for the study and space for documenting ordering physician, study indication, and information about the patient's implanted device (if their device is not followed by a UPHS physician). For CMS beneficiaries, an addition to the form will discuss the clinical trial and ask the referring physician how the results of the MRI will change patient treatment or prognosis and what would be done were an MRI not available. The approval of an attending radiologist in the radiology section that will be interpreting the study (e.g. neuroradiology for brain MRI, cardiovascular imaging for cardiac MRI) is required.
Once the patient is deemed eligible and consented, the study staff will enter the patient into the registry as well as register them onto the trial through PennChart.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Weeks
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pacemakers and/or implantable cardioverter defibrillators (ICD) referred for an outpatient Magnetic Resonance Imaging (MRI) procedure.
Key inclusion criteria (5 listed)
- Patients are at least 18 years of age
- Patients have a medically/clinically indicated need for an MRI as an outpatient
- Patients with a non-MRI conditional pacemaker and/or ICD implanted after the year 2000
- Patients are CMS beneficiaries
- Patients are willing and able to sign consent and HIPAA authorization or is authorized to sign consent for subject.
Key exclusion criteria (4 listed)
- Other contraindications to MRI
- Pacemaker or ICD implanted prior to the year 2000
- Patient is unwilling/unable to sign consent and HIPAA authorization
- Leads and/or generator implanted within 6 weeks of the proposed MRI
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 |
|---|---|---|
| MRIMRI | Other | – |
Primary outcome
Physician decision making
Time frame: 4 years
The primary measure of this study is physician decision making. Referring physicians will be asked about the effect of the MRI clinical management strategy, planning of treatments and interventions, as well as if/how the MRI results prevented other diagnostic studies or interventions, and other exposures (such as to ionizing radiation or iodinated contrast from CT scans). Analysis will be tabulation of how scan would change treatment or prognosis and what would be done if MR not available (based upon referring physician response on the screening form, physician and how the physicians believe that having the MRI will impact the treatment and quality of life by completing the QOL form.
1 secondary outcome
Adverse Events
Time frame: 4 years
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 14 May 2024.
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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.
Mitchell Schnall, MD, PhD study chair
University of Pennsylvania
Harold Litt, MD, PhD principal investigator
University of Pennsylvania
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 Pacemaker and Implantable Cardioverter Defibrillators, run by University of Pennsylvania 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 14 May 2024. 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?
Physician decision making (time frame: 4 years). 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 14 May 2024.