12 Months-observation of Patients Treated for Hidradenitis Suppurativa, With High Cardiovascular Risk or Established Coronary Plaque: A Prospective Monocentric Study - the HOPE Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 34
- 主要终点
- Proportion of Participants With Lack of Clinically Significant Progression of Coronary Atherosclerotic Plaque Between Baseline and 12 Months, as Measured by PCCT
研究概览
简要总结
The aim of this study is to assess the real-world effects of secukinumab in adult participants with moderate-to-severe Hidradenitis Suppurativa (HS), particularly focusing on its potential impact on coronary atherosclerotic plaque progression or stability. Participants will be enrolled at a single dermatology and cardiology center in Italy and will receive secukinumab as part of their routine clinical care
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult participants aged ≥18 and ≤75 years.
- •Diagnosis of moderate-to-severe HS (International Hidradenitis Suppurativa Severity Score System [IHS4] ≥4).
- •Taking or planning to take secukinumab according to standard of care.
- •Participants eligible for coronary imaging by Photon-Counting Computed Tomography (PCCT) based on at least one of the following:
- •Evidence of coronary atherosclerotic plaque previously identified by imaging and receipt of stable, guideline-directed medical therapy.
- •Clinical indication as determined by a cardiologist.
- •Very high risk of developing cardiovascular diseases according to the Systematic Coronary Risk Evaluation 2 (SCORE2) and Systematic Coronary Risk Evaluation 2 - Older Persons (SCORE2-OP) risk models for moderate risk European regions (score ≥7.5% for participants <50 years old, score ≥10% for participants 50-69 years old, and score ≥15% for participants ≥70 years old).
- •Signed Informed Consent Form (ICF), obtained from the participant or a legally authorized representative, prior to any study-related activities.
排除标准
- •Known history of previous Myocardial Infarction (MI), Acute Coronary Syndromes (ACS) or Transient Ischemic Attack (TIA) requiring urgent intervention/hospitalization in the last 6 months prior to enrollment.
- •Use of investigational cardiovascular or anti-inflammatory drugs.
- •Use of any other investigational drugs.
- •Chronic Kidney Disease (estimated Glomerular Filtration Rate [eGFR] <30 mL/min).
- •Contraindications to perform PCCT (including allergies to contrast).
- •Other autoimmune systemic diseases or active neoplastic diseases.
- •Known history of Moderate to severe anemia.
- •Congestive Heart Failure (New York Heart Association [NYHA] Class III-IV).
- •Pregnant or lactating women.
研究组 & 干预措施
Secukinumab Cohort
Adult participants with a confirmed diagnosis of moderate-to-severe HS and either a very high cardiovascular risk with no detectable plaque at baseline or a documented coronary atherosclerotic plaque, who are initiating or receiving secukinumab as part of routine clinical care.
结局指标
主要结局
Proportion of Participants With Lack of Clinically Significant Progression of Coronary Atherosclerotic Plaque Between Baseline and 12 Months, as Measured by PCCT
时间窗: Baseline to 12 months
Lack of clinically significant progression is defined as follows: • For participants with established coronary atherosclerotic plaque at baseline: no ≥10% increase in total plaque volume (mm\^3) • For participants with no detectable atherosclerotic plaque at baseline and a high risk of developing atherosclerotic cardiovascular disease (ASCVD): no new detectable plaque formation.
次要结局
- Number and Percentage of Participants With No Changes, Positive Changes, and Negative Changes in Coronary Artery Calcium (CAC) Score Between Baseline and 12 Months(Baseline to 12 months)
- Number and Percentage of Participants With No Changes, Positive Changes, and Negative Changes in the Densitometric Spectrum of the Coronary Atherosclerotic Plaque Between Baseline and 12 Months(Baseline to 12 months)
- Number and Percentage of Participants With No Changes, Positive Changes, and Negative Changes in the Degree of Coronary Artery Lumen Stenosis Between Baseline and 12 Months(Baseline to 12 months)
- Change in HS Severity, as Measured by IHS4, From Baseline to 6 Months and 12 Months(Baseline to 6 months and 12 months)
- Percentage Change in Total Coronary Atherosclerotic Plaque Volume Between Baseline and 12 Months, as Assessed by PCCT(Baseline to 12 months)