Statins to Prevent Immune Checkpoint Inhibitor-induced PRogression of AtherosLerosis
NCT06785974
Arterial Occlusive Diseases, Arteriosclerosis
Rotterdam, South Holland, Netherlands
View Trial DetailsNCT Number: NCT05180942
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.
Interested in participating?
Request Info40 year and older
All sexes
Observational
Nepean Hospital, Kingswood, New South Wales, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 18 months
The change in non-calcified coronary plaque volume will be measured on serial computed tomography coronary angiography scans.
Time frame: 18 months
Time frame: 18 months
The change in non-calcified coronary plaque volume as measured on serial computed tomography coronary angiography scans will be compared between patients treated with statins and patients not treated with statins in the study.
Time frame: 18 months
The number of patients who were started on statin therapy by their treating clinicians after undergoing computed tomography coronary angiography in the study will be recorded.
Time frame: 18 months
Quality of life will be assessed by using the PHQ-9, GAD-7, EORTC QLQ-C30, EuroQOL EQ-5D, and FACT-M questionnaires at baseline and at 18 month follow up. The change in quality of life scores on each questionnaire will be compared with historical cohorts that have previously been reported in the literature.
Time frame: 18 months
Time frame: 18 months
Time frame: 18 months
Contact information is provided by the study sponsor or research team.
Monash University
Other
Acronym: SOCRATES
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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.
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