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NCT06332131 Clinical Trial

Effects of Immune Checkpoint Inhibitors on Coronary Microvasculature

Melanoma Clinical Trial

Official title:
Effects of Immune Checkpoint Inhibitors on Coronary Microvasculature

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06332131
Other study ID # UPCC07623
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 2024
Est. completion date April 2027

Study information
Verified date May 2024
Source Abramson Cancer Center at Penn Medicine
Contact Marielle Scherrer-Crosbie, MD, PhD
Phone (215) 662-3569
Email marielle.scherrer-crosbie@pennmedicine.upenn.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 25
Est. completion date April 2027
Est. primary completion date April 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Abramson Cancer Center at University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Abramson Cancer Center at Penn Medicine

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of new abnormal myocardial blood flow reserve (MBFR) Development of MBFR<2 12 months
Secondary Incidence of major cardiovascular events Composite measure including new/worsened heart failure, MI, stroke, myocarditis 12 months
Secondary Coronary calcium score Change in PET derived Coronary Calcium (CAC) Score from baseline. CAC ranges from 0-400 agatson units; higher CAC indicates larger amounts of calcium are present in the coronary arteries. 12 month
Secondary All cause mortality All cause mortality 12 months
Secondary Cardiovascular specific mortality Cardiovascular specific mortality 12 months
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