Protocollo Sulla Valutazione Del RischiO cardioVAscolare Nel Crohn e ColIte Ulcerosa (PROVACI). Estimation of Cardiovascular Risk in Crohn's Disease and Ulcerative Colitis
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Occurrence of Major cardiovascular events
研究概览
简要总结
Inflammatory bowel diseases (IBD) are progressively increasing their prevalence worldwide. Up to half of patients may also have extraintestinal manifestation and cardiovascular diseases (CVDs) is one of the most relevant, being the second cause of death in these patients. The classical cardiovascular (CV) risk scores do not adquately capture the CV risk in IBD.
We are planning a prospective observational study to evaluate patients with IBD and a gender/age-matched cohort with the aims to investigate in 2-years follow-up
- Occurrence of major cardiovascular events (MACEs) in both cohorts;
- Predictive factors of risk for MACEs in IBD compared to controls;
- Multi-omics evaluations with the support of artificial intelligence of biomarkers associated with occurrence of MACEs in IBD
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with confrimed diagnosis of Crohn's disease and Ulcerative colitis-
排除标准
- •No willing to sign the informe content and have 2 years of follow-up
结局指标
主要结局
Occurrence of Major cardiovascular events
时间窗: 2 years
Myocardial infarction, stroke, transient ischemic attack, heart failure, atrial fibrillation, acute arterial embolysm, ischemic angina
次要结局
- Multi-omics evaluations of biomarkers in IBD patients with occurrence of MACEs(2 years follow-up)
研究者
Vito Annese
Associate Professor University Vita-Salute San Raffaele, Milan; Head of Gastroenterology IRCCS San Donato Policlinic
IRCCS Policlinico S. Donato