Cardiovascular Risk Profile in High CV Risk Obese Patients Before and After Endoscopic Sleeve Gastroplasty: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Quantification of the impact of endoscopic sleeve gastroplasty on Cardiovascular risk
研究概览
简要总结
The primary outcome of this study is to evaluate changes in cardiovascular risk after endoscopic sleeve gastroplasty (ESG) in patients at high cardiovascular risk, using the SCORE2 ( Systematic COronary Risk Evaluation 2) and SCORE2-OP ( Systematic COronary Risk Evaluation 2 Older Persons) risk scores, which estimate the risk of having a cardiovascular event.
详细描述
This study aims to evaluate whether endoscopic sleeve gastroplasty (ESG), a minimally invasive procedure that reduces the size of the stomach, may improve cardiovascular health in patients with a high risk of cardiovascular disease.
Cardiovascular risk refers to the likelihood of developing serious conditions such as heart attack or stroke. In this study, cardiovascular risk will be assessed using two validated risk scores: SCORE2 (Systematic COronary Risk Evaluation 2), used mainly in adults aged 40-69 years, and SCORE2-OP (Systematic COronary Risk Evaluation 2 - Older Persons), used in people aged 70 years and older. Risk modifiers include coronary calcium score (CAC), coronary angiography and the socioeconomic status, as well as the presence of specific comorbidities. Following recent scientific evidence, circulating biomarkers as well as imaging biomarkers like epicardial fat (EAT) characterization, the quantification of oxidative stress and the composition and role of gut microbiota are proposed to stratify and personalize the calculation of Cardiovascular risk (CV) and therefore improve CV prognosis
研究设计
- 研究类型
- 干预性
- 分配方式
- 不适用
- 干预模型
- 单组
- 主要目的
- 其他
- 盲法
- 开放（无盲法）
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
- informed consent
- obesity or overweight
- atherosclerotic cardiovascular disease
- type 1 or type 2 diabetes mellitus
- hypercholesterolemia or severe dyslipidemia
- evidence of subclinical atherosclerosis
排除标准
- chronic inflammatory diseases
- active viral or bacterial infections
- severe anaemia or severe coagulopathy
- severe chronic kidney failure
- active malignancy
- anticoagulant therapy
- chronic treatment with immunosuppressants/immunomodulators
- pregnancy
研究组 & 干预措施
Patients Undergoing Endoscopic Sleeve Gastroplasty
A total of 20 mL will be collected. Urine samples will be collected before Endoscopic Sleeve Gastroplasty and in sterile conditions. Imaging techniques will be performed before ESG procedure as well.
干预措施: echocardiography (Other)
Patients Undergoing Endoscopic Sleeve Gastroplasty
A total of 20 mL will be collected. Urine samples will be collected before Endoscopic Sleeve Gastroplasty and in sterile conditions. Imaging techniques will be performed before ESG procedure as well.
干预措施: Coronary CT angiography (Radiation)
Patients Undergoing Endoscopic Sleeve Gastroplasty
A total of 20 mL will be collected. Urine samples will be collected before Endoscopic Sleeve Gastroplasty and in sterile conditions. Imaging techniques will be performed before ESG procedure as well.
干预措施: blood analysis (Biological)
结局指标
主要结局
Quantification of the impact of endoscopic sleeve gastroplasty on Cardiovascular risk
时间窗: From enrollment to the end of follow up at 12 months
次要结局
未报告次要终点
研究者
研究点 (1)
标识符
- NCT 编号
- NCT07847307
- 其他研究编号
- ENDOBARIHEART STUDY
日期
- 首次提交
- (8天前)
- 首次发布
- (昨天)
- 主要完成日期
- (2年后)
- 研究完成日期
- (2年后)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否