Tako-Tsubo Cardiomyopathy and Cardiac Syndrome X: New Insights Into the Pathophysiology of Two Orphan Cardiac Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Difference in endothelial function in response to autonomic tone (Endopat score)
研究概览
简要总结
Tako-Tsubo Cardiomyopathy (TTC) and Cardiac Syndrome X (CSX) are respectively acute and chronic cardiac conditions whose clinical presentation, mimicking the onset of acute myocardial ischemia in absence of epicardial coronary disease, has progressively gained the interest of the scientific community. However, despite significant progress, their underlying pathophysiology, which seems to evoke some similarities, still remains elusive. Endothelial dysfunction and autonomic imbalance have both been individually implied in their puzzling pathogenesis.
The investigators plan to conduct our study in a cohort of TTC patients, CSX patients and healthy volunteers with the following primary objective: to assess the response of endothelial function (through the Endopat score) to the autonomic tone activation induced by a 10-minute stress mental test. The assessment of autonomic tone during activation through the evaluation of Spontaneous BaRoreflex Sensitivity (BRS) and its correlation with endothelial function (Endopat score) will represent secondary objectives.
Our study will enroll 15 patients with TTC at least six months after the event, 15 patients with classic CSX and 15 healthy volunteers who will serve as control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with the Mayo Clinic's criteria established diagnosis of TTC at least 6 month after the acute event
- •Patients with CSX defined by the presence of anginal pain, positive exercise stress testing and negative coronary angiography.
- •A comparable cohort of healthy volunteers age and sex-matched with patients
排除标准
- •Short-term life-threatening pathology (life expectancy < 6 months)
- •Physically unable to participate in the study
- •Compliance not guaranteed
- •Pregnancy
- •Conditions that make BRS and Endopat measurements impossible
结局指标
主要结局
Difference in endothelial function in response to autonomic tone (Endopat score)
时间窗: Baseline
Difference in endothelial function assessed by Endopat score in response to autonomic tone induced by 10-minute mental stress test between the three groups (CSX, TTC, healty volunteers)
次要结局
- BaroReflex Sensitivity (Sensitivity measurement by volume-clamp method (Finapress)(Baseline)
- Endothelial dysfunction (Changes in Endopat score)(Baseline)
- BaroReflex Sensitivity and endothelial dysfunction ((Baseline)
研究者
Professor Augusto Gallino
Professor MD
Ospedale San Giovanni Bellinzona