Baylor Scott and White Vascular Hospital
Dallas, Texas, 75226, United States
NCT Number: NCT07679009
This is a prospective cohort study looking to systematically evaluate the safety of conducting cardiac Magnetic Resonance Imaging (MRI) in this high-risk patient group with abandoned, fractured endocardial leads or surgically implanted permanent epicardial leads, by monitoring clinical outcome and device functionality (if active device present).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Dallas, Texas, 75226, United States
This is a prospective cohort study involving patients with abandoned, fractured endocardial leads, or surgically placed permanent epicardial leads with or without concurrent active cardiac implantable electronic devices (CIEDs), who need cardiac MRI for clinical indications. Participants will undergo a thorough pre-scan evaluation, including chest x-ray (CXR), device interrogation, lead integrity check, and risk assessment. The MRI will be performed using a standardized protocol designed to minimize risks, with continuous patient monitoring during the procedure. Post-scan device interrogation and patient evaluation will assess any immediate and delayed adverse effects.
This study is a descriptive case series, and no statistical comparisons with controls will be made. Descriptive statistics of continuous patient and CIED variables are expressed as the mean+/- SDs (standard deviations), or as medians with interquartile ranges (IOR). Categorical variables are expressed as numbers and percentages.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Within 6 weeks post device implantation, unless more urgent clinical needs dictate an earlier scan;
Conducting cardiac MRI in a high-risk patient group with abandoned, fractured endocardial leads or surgically implanted permanent epicardial leads, by monitoring clinical outcome and device functionality (if active device present) to determine the diagnostic value of Cardiac MRI in these patients.
Time frame: 6 months
To systematically evaluate the safety of conducting cardiac Magnetic Resonance Imaging (MRI) in this high-risk patient group with abandoned, fractured endocardial leads or surgically implanted permanent epicardial leads, by monitoring clinical outcome and device functionality (if active device present). This is done by evaluating and reviewing the CMR images.
Time frame: 6 months
To determine the diagnostic value of cardiac MRI in these patients, including the quality of imaging and the ability to address clinical questions. This is done by evaluating and reviewing the CMR images.
Time frame: 2 years.
To develop and refine cardiac MRI protocols that effectively minimize risks while maintaining diagnostic quality in this patient group. This is done by taking the results of the CMR imaging and data collected and implementing changes to future protocol to minimize risks.
Baylor Research Institute
Other
Evaluating the Safety and Diagnostic Utility of Cardiac MRI in Patients With Abandoned, Fractured Endocardial Leads or Permanent Epicardial Leads
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