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COMPLETED
NCT06020651
NA

Vascular Toxicities of Immune ChecKpoint Inhibitors : From Bed to Benchside

Sponsor: Institut Mutualiste Montsouris

View on ClinicalTrials.gov

Summary

Immune checkpoint inhibitors (ICIs) are largely prescribed in a growing number of cancer diseases and at earlier stages (non metastatic cancer). Among immune-related adverse events, (iRAEs), the incidence of major cardiovascular events due to atherosclerosis reaches 13% at one year in patients at high risk. To the best of our knowledge, the mechanisms of this acceleration of atherosclerosis have not been studied to this date. The VICKI study aims at furthering our knowledge on the mechanisms of atherosclerotic plaque instability by means of a prospective single-centre pilot study, by comparing: * surrogate markers of clinical vasculo-toxicity with arterial Doppler (flow mediated reserve) as defined by the International Cardio-Oncology Society; * circulating biomarkers Before and after receiving ICIs for solid cancer treatment.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

39

Start Date

2023-06-07

Completion Date

2025-06-01

Last Updated

2026-04-08

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Arterial Doppler for Flow Mediated Reserve measurement

Arterial Doppler (ultrasound, no radiation, no contrast agent) and blood sampling twice for participants on ICIs

Locations (1)

INstitut Mutualiste Montsouris

Paris, France