Prospective Single-center Study of a Cohort of Patients With Oral Lichen Planus: Cardiovascular and Prothrombotic Risk in Patients With Oral Lichen Planus (OLP).
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 55
- 主要终点
- Prothrombotic risk evaluation
研究概览
简要总结
The primary objective is to evaluate the cardiovascular profile and the risk of thrombotic events in patients affected by Oral Lichen Planus.
详细描述
Evaluation of thrombophilia screening parameters, antiphospholipid antibody levels, and platelet aggregability in a cohort of patients affected by Oral Lichen Planus.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a clinical and histological diagnosis of Oral Lichen Planus
- •Age > 18 years
- •Patients who agree to sign the informed consent form
排除标准
- •Patients under 18 years of age
- •Patients who do not agree to sign the informed consent form
- •Patients without a diagnosis of Oral Lichen Planus
- •Patients with previously known cardiac diseases
- •History of major cardiovascular events (myocardial infarction, ischemic stroke, TIA)
- •Patients with overt heart failure (NYHA class III-IV)
- •Cardiomyopathies not related to the studied risk factors (e.g., genetic hypertrophic cardiomyopathy)
- •Patients undergoing anticoagulant therapy
- •Patients with primary or secondary conditions associated with increased cardiovascular risk
结局指标
主要结局
Prothrombotic risk evaluation
时间窗: From September 2025 to September 2026
Primary Outcome Measure 1 Title: Prevalence of Natural Anticoagulant Deficiency * Description: Proportion of patients with Oral Lichen Planus (OLP) showing reduced functional activity of at least one natural anticoagulant (antithrombin III, protein C, or protein S) below the laboratory reference range, measured in plasma samples. * Time Frame: From September 2025 to September 2026 * Unit of Measure: Percentage of participants with abnormal result (%). Primary Outcome Measure 2 Title: Prevalence of Antiphospholipid Antibody Positivity * Description: Proportion of OLP patients with positive antiphospholipid antibodies, defined as anticardiolipin IgG and/or IgM and/or anti-β2-glycoprotein I IgG/IgM above the laboratory cut-off, measured in serum. * Time Frame: From September 2025 to September 2026 * Unit of Measure: Percentage of participants with abnormal result (%).
次要结局
未报告次要终点