RecruitingNCT05180942

Statins and prOgression of Coronary atheRosclerosis in melanomA Patients Treated With chEckpoint inhibitorS


Sponsor

Monash University

Enrollment

130 participants

Start Date

Nov 7, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

This study is a prospective observational study evaluating the natural history of coronary plaque burden in participants with melanoma treated with ICI. The study will be conducted at various sites across Australia.


Eligibility

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether statin medications (cholesterol-lowering drugs) can slow the buildup of plaque in coronary arteries (arteries supplying the heart) in melanoma patients who are being treated with checkpoint inhibitor immunotherapy, which can sometimes accelerate heart disease. **You may be eligible if:** - You are 40 years or older - You have been diagnosed with melanoma at any stage and are receiving, planning to receive, or have completed immunotherapy treatment - Your heart imaging (CT coronary angiogram) is of acceptable quality - You are willing to return for follow-up imaging **You may NOT be eligible if:** - You already have known, clinically apparent heart or cardiovascular disease - You are pregnant, breastfeeding, or planning to become pregnant during the study - Your kidney function is significantly reduced - You have severe liver disease - You have had another cancer in the past 5 years (besides non-melanoma skin cancer) - Your expected survival is less than 18 months - You have a severe allergy to iodine (used in imaging contrast) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(12)

Nepean Hospital

Kingswood, New South Wales, Australia

Calvary Mater Newcastle

Waratah, New South Wales, Australia

Bundaberg Base Hospital

Bundaberg, Queensland, Australia

Hervey Bay Hospital

Hervey Bay, Queensland, Australia

Ipswich Hospital

Ipswich, Queensland, Australia

Toowoomba Hospital

Toowoomba, Queensland, Australia

Queen Elizabeth Hospital

Woodville South, South Australia, Australia

Monash Health

Clayton, Victoria, Australia

Peninsula Health

Frankston, Victoria, Australia

Cabrini Health

Malvern, Victoria, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Mildura Public Base Hospital

Mildura, Victoria, Australia

View Full Details on ClinicalTrials.gov

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NCT05180942


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