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Effects of Immune Checkpoint Inhibitors on Coronary Microvasculature
This is an observational study that includes patients with melanoma who will be treated with adjuvant immune checkpoint inhibitor (ICI) therapy. The investigators will use echocardiograms, blood draws, and PET stress tests to understand how ICI therapy affects the heart and circulatory system.
Conditions:
🦠 Melanoma 🦠 Coronary Microvascular Dysfunction 🦠 Cardiotoxicity
🗓️ Study Start (Actual) July 2024
🗓️ Primary Completion (Estimated) April 2027
✅ Study Completion (Estimated) April 2027
👥 Enrollment (Estimated) 25
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Philadelphia, Pennsylvania, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * ≥18 years of age
    • * Diagnosis of Melanoma and planned to undergo adjuvant therapy with immune checkpoint inhibitors.
    • * Able to provide written informed consent

    Exclusion Criteria:

    • * Pregnant or breast-feeding:
    • * Prior treatment with ICI therapy.
    • * Vulnerable patients, including pregnant women and prisoners
    • * Absolute Contraindication to rest/vasodilator stress PET/CT
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 20 March 2024
  • First Submitted that Met QC Criteria 20 March 2024
  • First Posted 27 March 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 29 July 2024
  • Last Update Posted 30 July 2024
  • Last Verified July 2024
I'm interested ...!!