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OpenTrials
Enrolling by Invitation

NCT Number: NCT07679009

Diagnostic Utility of Cardiac MRI

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).

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baylor Scott and White Vascular Hospital

Dallas, Texas, 75226, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals 18 years and older
  • Individuals with abandoned, fractured endocardial
  • Individuals with permanent epicardial pacemaker or implantable cardioverter-defibrillator (ICD) leads

Exclusion criteria

Within 6 weeks post device implantation, unless more urgent clinical needs dictate an earlier scan;

  • Pregnant individuals
  • Individuals with severe claustrophobia
  • Individuals with other known contraindications for MRI, as determined by study doctor

Treatment and study plan

Cardiac MRI (CMR)

Device

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.

Primary outcomes

  1. Evaluating the safety of CMR

    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.

Secondary outcomes

  1. Diagnostic Value of CMR

    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.

  2. Protocol Development.

    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.

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Registry information

Official study title

Evaluating the Safety and Diagnostic Utility of Cardiac MRI in Patients With Abandoned, Fractured Endocardial Leads or Permanent Epicardial Leads

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 1, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.