Management of Hyperglycemia in INOCA Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,000
- 主要终点
- Risk of Re-Hospitalization
研究概览
简要总结
Ischemia with non-obstructive coronary arteries (INOCA) is common in patients with angina. INOCA has been associated with an increased risk of death, myocardial infarction, and stroke, particularly in symptomatic subjects. Previous investigations have evidenced the key role of poor glycemic control and diabetes in coronary microvascular dysfunction. Metformin is an old oral antidiabetic drug which is currently used to achieve glycemic control.
详细描述
Ischemia with non-obstructive coronary arteries (INOCA) is common in patients with angina. INOCA has been associated with an increased risk of death, myocardial infarction, and stroke, particularly in symptomatic subjects. Coronary microvascular dysfunction, triggering structural remodeling and vasomotor disorders of coronary arterioles, is currently one of the leading hypotheses to explain INOCA pathophysiology. Previous investigations have evidenced the key role of poor glycemic control and diabetes in coronary microvascular dysfunction. Metformin is an old oral antidiabetic drug which is currently used to achieve glycemic control. Also, previous reports evidenced that metformin improves endothelial dysfunction. Nowadays, it is used in prediabetic patients too. In this scenario, we evaluated the role of metformin in reducing the risk of re-hospitalization in INOCA.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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
- •age ≥18 years;
- •diagnosis of INOCA;
- •availability to participate in the study
排除标准
- •atrial fibrillation or left bundle branch block;
- •previous acute coronary syndrome (ACS) or cardiac revascularization; -pregnancy;
- •severe heart valve disease
研究组 & 干预措施
Treated/No treated
干预措施: Metformin (Drug)
结局指标
主要结局
Risk of Re-Hospitalization
时间窗: 2016-2021
Risk of Re-Hospitalization. The primary outcome measure will be the risk of re-hospitalization; to assess this outcome, we will assess the actual number of re-hospitalization events for each patients.
次要结局
- MACE(2016-2021)
研究者
Pasquale Mone
Principal Investigator
University of Campania "Luigi Vanvitelli"