Carotid Plaque, Echocardiography, Hyperlipidemia
Conditions
Keywords
inclisiran, carotid plaque, Echocardiography, hyperlipidmia
Brief summary
Current understanding suggests that the majority of cardiovascular events are driven by vulnerable plaques. Nonetheless, the impact of PCSK9 inhibitors on the stability of carotid plaques remains insufficiently elucidated, with a notable scarcity of relevant clinical studies. This investigation seeks to address this gap through a real-world study conducted among patients with arterial sclerosis in Asia. The primary aim is to evaluate the effects of small interfering RNA (inclisiran) on carotid plaque characteristics as assessed by ultrasound, thereby contributing valuable data to inform clinical practice.
Detailed description
In a meticulous study evaluating the impact of inclisiran on patients with atherosclerosis and carotid plaques, data were systematically gathered across multiple time points. The assessment encompassed:Blood Samples: Analyzed at baseline (Month 0) and subsequently at Months 1, 2, 3, 5, 9, 11, and 12, examining biochemical markers, lipid profiles, and liver and kidney function tests.Carotid Ultrasound: Conducted at Months 0, 3, 9, and 12, monitoring the carotid intima-media thickness, maximum carotid plaque thickness, carotid plaque area, carotid plaque volume, and carotid lumen stenosis area for thorough analysis.Clinical Records: Documented in detail the baseline clinical information, biochemical markers, imaging findings, and any adverse cardiovascular or cerebrovascular events that occurred throughout the study period. This approach ensures a comprehensive understanding of inclisiran's effects over time, encompassing both biochemical and imaging parameters, while tracking potential adverse events.
Interventions
DRUGInclisiran
Patients with carotid plaques undergoing treatment with inclisiran
Sponsors
First Affiliated Hospital of Xinjiang Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with carotid plaques as indicated by ultrasound * Men and women aged 18-75 years; * LDL-C >3.4 mmol/L without regular statin therapy or LDL-C >1.8 mmol/L after 4 weeks of statin lipid-lowering therapy.
Exclusion criteria
* \- Known allergies or contraindications to PCSK9 inhibitors and/or statin therapy; * Prior use of PCSK9 inhibitors; * Prior history of hemorrhagic stroke; * Prior coronary artery bypass grafting or coronary intervention; * Inability to perform OCT imaging or unclear imaging; * Severe renal insufficiency (creatinine clearance < 30 mL/min); * Severe hepatic dysfunction; * Baseline triglycerides > 5.6 mmol/L; * Pregnant or lactating women; * Life expectancy not exceeding 1 year; * In the judgment of the investigator, unsuitable for this study for any reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CIMT | Immediately and treated with inclisiran one year later | Carotid artery intima media thickness |
| TMPT | Immediately and treated with inclisiran one year later | The maximal plaque thickness |
| CPA | Immediately and treated with inclisiran one year later | Carotid plaque area |
| CPV | Immediately and treated with inclisiran one year later | Carotid plaque volume |
| CALA | Immediately and treated with inclisiran one year later | Carotid artery lumen area |
Contacts
Primary ContactYuanhao Yao, MD
Outcome results
None listed