Carotid Artery Plaque, Immune Checkpoint Inhibitors, Intimal Medial Thickness of Internal Carotid Artery, Plaque, Atherosclerotic, Programmed Cell Death Protein 1 Inhibitor
Conditions
Brief summary
A Perspective, Self-control Study on the Progression of Carotid Plaques in Anti-PD-1 mAb Treated Tumor Patients by Artery Ultrasound Follow-up
Detailed description
This is a perspective, self-controlled cohort study. This study aims to evaluate the effectiveness of anti-PD-1 mAbs (PD-1 immune checkpoint blockades) on atherosclerotic carotid plaques in those anti-PD-1 mAbs treated patients. The method for quantification and evaluation of atherosclerotic plaques are based on the: 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 burden: 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 carotid artery in each patient when initiate the first-dose of anti-PD-1 mAbs therapy and 3 months post anti-PD-1 mAbs therapy. It is designed to assess the effectiveness of anti-PD-1 mAbs on the progression of carotid plaques.
Interventions
DRUGPD-1 immune checkpoint blockades
intravenous injection; frequency: 2-3 weeks/cycle; duration: 3 months
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Inclusion criteria
1. The age of subjects are between 18-90 years old (including 18 and 90 years old); 2. All kinds of tumor diseases of subjects are acceptable; 3. All kinds of PD-1 immune checkpoint blockades or dosages are acceptable; 4. The subjects knew about the experiment and signed the informed consent voluntarily; 5. The subjects plan to receive PD-1 immune checkpoint blockades and potentially to be treated for over 3 months; 6. The subjects complicated with atherosclerotic carotid plaques.
Exclusion criteria
1. Subjects stop receiving or changing the PD-1 immune checkpoint blockades during follow-up; 2. Subjects are reluctant to continue to be involved in this study; 3. Known pregnant and lactating women; 4. The parameters (e.g., CCA intima-media, ICA intima-media or carotid plaque burden) could not be calculated because of the quality of ultrasound image; 5. Other situations that the researchers judged were not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The mean intima-media thickness of the common carotid artery | 3 months | It was measured over a segment of the common carotid artery that was 1 cm long, located approximately 0.5 cm below the carotid-artery bulb, and considered not to contain any plaque (i.e., not to have any perceivable protrusion of the artery wall into the lumen). |
| The maximum intima-media thickness of the internal carotid artery | 3 months | It was defined as the greatest intima-media thickness in either the right or left internal carotid artery extending from the bulb to 1 cm above the carotid sinus, ascertained from a total of four views on each side. |
| Carotid plaque burden | 3 months | Carotid plaque area measured by ultrasound (cross-sectional area of longitudinal views of all plaques seen) to quantify the increase or decrease of atherosclerotic carotid plaques. |
Countries
China
Contacts
Primary ContactJianan Wang, MD, PhD
Backup ContactLin Fan, PhD
Outcome results
None listed