Study Evaluating the Use of MRI on CMS Patients

Pacemaker Clinical Trial

— PM/ICD  

Official title:

Prospective Observational Study Evaluating the Use of MRI on CMS Beneficiaries With Non-Conditional Pacemakers and/or Implantable Cardioverter Defibrillators

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02513056
• Other study ID #: 821487
• Status: Completed
• Start date: August 17, 2015
• Est. completion date: February 1, 2022

Study information

• Verified date: May 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 872
• Est. completion date: February 1, 2022
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients are at least 18 years of age

2. Patients have a medically/clinically indicated need for an MRI as an outpatient

3. Patients with a non-MRI conditional pacemaker and/or ICD implanted after the year 2000

4. Patients are CMS beneficiaries

5. Patients are willing and able to sign consent and HIPAA authorization or is authorized to sign consent for subject.

Exclusion Criteria:

1. Other contraindications to MRI

2. Pacemaker or ICD implanted prior to the year 2000

3. Patient is unwilling/unable to sign consent and HIPAA authorization

4. Leads and/or generator implanted within 6 weeks of the proposed MRI

Related Conditions & MeSH terms

• Implantable Cardioverter Defibrillators
• Pacemaker

Intervention

Other:
• MRI
MRI

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patients will be asked how the MRI affected their quality of life, concerning	Patients will complete a Quality of Life form identifying how the MRI affected their quality of life, concerning both the MRI procedure itself and the fact that the MRI could be performed and diagnostic information about their conditions obtained.	4 years
Primary	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.	4 years
Secondary	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.	4 years