Cardiomyocyte Injury Following Acute Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Rate of myocardial edema without late gadolinium enhancement (native T1, T2 mapping)
研究概览
简要总结
The primary goal of the CORONA-IS study is to characterize stroke-associated acute myocardial injury (elevated hs-cardiac troponin) using different diagnostic examinations in order get a better understanding of it's underlying pathomechanisms.
详细描述
Myocardial injury (i.e. elevated cardiac troponin levels) is a frequent cardiac complication during the first few days after an ischemic stroke and is associated with a poor functional outcome. Myocardial injury represents one essential part of a broad spectrum of cardiac complications ranging to severe arrhythmia or heart failure. There is evidence that, in the majority of patients, the underlying mechanism of stroke-associated myocardial injury is not coronary-mediated myocardial ischemia but rather stroke-induced functional and structural interference in the central autonomic network. The investigators hypothesize that this causes a dysregulation of normal neuronal cardiac control leading to myocardial edema and stunning ('Stroke-Heart-Syndrome') CORONA-IS is a prospective, observational, single-centered cohort study that will recruit 300 patients with acute ischemic stroke. According to serial high sensitivity cTn levels during the first 24h after admission, patients will be assigned to three groups (no myocardial injury, chronic myocardial injury, acute myocardial injury). Study procedures include cardiovascular MRI and transthoracic echocardiography to visualize (transient) cardiac dysfunction and provide detailed tissue characterization, 20-minute Holter-monitoring with an analysis of specific autonomic markers, and a systematic bio-banking to study further mechanisms such as altered microRNA signatures. A follow-up for cardiovascular events will be conducted one year after enrolment to study long-term effects of stoke-associated myocardial injury.
The aim of the CORONA-IS study is to develop a better understanding of the characteristics and the pathophysiology of stroke-induced acute myocardial injury ('Stroke-Heart-Syndrome') in order to identify patients at risk and improve diagnostic and therapeutic procedures.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age over 18
- •diagnosis of acute ischemic stroke and hospital admission within 48h after onset of the symptoms
- •diagnosis based on visible DWI-lesion in MRI
- •written informed consent by participant
- •repeated measurement of high sensitive Troponin T within 24h of admission (hs-troponin T, Roche Elecsys®,
- •percentile, upper reference limit=14ng/l)
排除标准
- •Pregnancy and / or breast-feeding.
- •Impaired renal function (eGFR < 30 ml/min/1,73 m^2)
- •Contraindications to undergo MRI (i.e., mechanic heart valve, cardiac pacemaker, etc.)
- •Persistent or permanent atrial fibrillation
- •ST- elevation myocardial infarction
- •History of coronary artery bypass surgery or percutaneous trans-luminal coronary angioplasty (PTCA) ≤ four weeks
结局指标
主要结局
Rate of myocardial edema without late gadolinium enhancement (native T1, T2 mapping)
时间窗: within five days of admission to hospital
diagnosed in cardiovascular MRI (CMR), conducted at the fourth/fifth day after onset of the ischemic stroke
Rate of myocardial fibrosis with late Gadolinium enhancement (LGE) and acute edema in CMR
时间窗: within five days of admission to hospital
Rate of myocardial fibrosis with LGE and acute edema in CMR, suggesting a recent myocardial infarction (\<1 month). CMR conducted at the fourth/fifth day after onset of the ischemic stroke.
Rate of acute disturbance of microcirculation
时间窗: within five days of admission to hospital
Rate of acute disturbance of microcirculation (measurement on the basis of oxygen extraction in cardiac MRI). CMR conducted at the fourth/fifth day after onset of the ischemic stroke.
Rate of impaired left ventricular function and transient impaired left ventricular function in transthoracic echocardiography
时间窗: within seven days of admission to hospital
Rate of impaired left ventricular function (ejection fraction \<50%, reduced global longitudinal strain etc.) in the transthoracic echocardiography as well as higher rate of transient left ventricular dysfunction detected in repeated transthoracic echocardiography (TTE). The TTE will be conducted at the first day after enrolment as well as at the day before discharge or five days after the first TTE respectively.
Rate of signs of left ventricular dysfunction in the CMR
时间窗: within five days of admission to hospital
Rate of signs of left ventricular dysfunction in the cardiac MRI (i.e. reduced ejection fraction, end diastolic left ventricular volume, longitudinal strain rate). CMR conducted at the fourth/fifth day after onset of the ischemic stroke.
次要结局
- Rate of pathologic Periodic Repolarization Dynamics (PRDs) and Deceleration Capacity (DC)(within seven days of admission to hospital)
- Difference in specific microRNA pattern in participants with myocardial damage induced by acute ischemic stroke(within seven days of admission to hospital)
- Functional outcome(at baseline, at seven days after baseline (or at day of discharge from hospital if <7d, respectively) and at twelve months after the initial event)
- Rate of cardiovascular events(at one week and at twelve months after the initial event)
- Mortality(at one week and twelve months after the initial event)
研究者
Dr. med. Jan Friedrich Scheitz
Principal Investigator, Clinician Scientist
Charite University, Berlin, Germany