single-center, prospective cohort study of pd-1 inhibitors on clinical outcomes of carotid plaques in tumor patients

Conditions: Carotid Artery Plaque; Pd-1 Inhibitors

Summary: this is a single-center, prospective cohort study on the comparison of clinical outcomes of carotid plaques in pd-1-treated tumor patients vs non-pd-1-treated tumor patients.

atherosclerosis, a chronic inflammatory disorder, leads to cardio-cerebrovascular diseases, causing most of the global deaths. the chronic and non-resolved inflammatory responses of both innate and adaptive immune cells are involved in the all-stage pathogenesis of atherosclerosis. the impairment of inflammatory resolution promotes atherogenesis and causes instability of atherosclerotic plaques. their subsequent rupture would induce severe cardio-cerebrovascular incidences (e.g., acute myocardial infarction and ischemic strokes). recent progress in anti-inflammatory immunotherapies on human atherosclerosis opens the door to resolving this inflammatory disorder by targeting the immune system. however, the impacts of pd-1 immune checkpoint blockades on the progressions of human carotid plaques are not determined yet. this is a prospective cohort study, which aims to evaluate the effectiveness of pd-1 immune checkpoint blockades on atherosclerotic carotid plaques in tumor patients in comparison to those with non-pd-1-treated tumor patients. the method for quantification and evaluation of atherosclerotic plaques are based on: (1) the mean intima-media thickness of the common carotid artery (mean cca thickness); (2) the maximum intima-media thickness of the internal carotid artery (maximum ica thickness); (3) carotid plaque areas: by calculation of the plaque area of atherosclerotic plaques on the long axis direction of artery on the ultrasound images. by comparing the above-mentioned parameters at the same location of the carotid artery in the patients when initiating the first dose of anti-pd-1 or non-pd-1 chemotherapy and 3 months after anti-pd-1 or non-pd-1 chemotherapy. it is designed to assess the effectiveness of pd-1 immune checkpoint blockades or non-pd-1 chemotherapy on the clinical prognosis of carotid plaques after a period of 3-month treatment.

Eligibility criteria:
inclusion criteria: 1. subjects know about the experiment and signed the informed consent voluntarily; and 2. subjects are tumor patients and all kinds of tumor diseases of subjects are acceptable; and 3. subjects are initiating to receive chemotherapy; and 4. subjects are diagnosed with atherosclerotic carotid plaques by ultrasound examination at the timepoint of the first-dose treatment; and exclusion criteria: 1. subjects stop receiving or changing the existing chemotherapy during follow-up; or 2. subjects are reluctant to continue to be involved in this study; or 3. subjects are known pregnant and lactating women; or 4. subjects are not complicated with atherosclerotic carotid plaques at the timepoint of the first-dose treatment; or 4. the parameters (e.g., cca intima-media, ica intima-media, or carotid plaque area) could not be calculated because of the quality of the ultrasound image; or 5. other situations that the researchers judged are not suitable for further inclusion.