Clinical trial NCT02513056: Study Evaluating the Use of MRI on CMS Patients
Official title: Prospective Observational Study Evaluating the Use of MRI on CMS Beneficiaries With Non-Conditional Pacemakers and/or Implantable Cardioverter Defibrillators
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pacemaker
Implantable Cardioverter Defibrillators
Keywords: non-conditional pacemakers
implantable cardioverter defibrillator
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2015-07-31
Enrollment: 872
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pacemakers and/or implantable cardioverter defibrillators (ICD) referred for an outpatient Magnetic Resonance Imaging (MRI) procedure.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Physician decision making
timeFrame: 4 years
Secondary outcomes:
measure: Adverse Events
timeFrame: 4 years
Other outcomes:
measure: Patients will be asked how the MRI affected their quality of life, concerning
timeFrame: 4 years
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Mitchell Schnall, MD, PhD
role: STUDY_CHAIR
affiliation: University of Pennsylvania
name: Harold Litt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: