Incidence, Influencing Factors and Outcome of Takotsubo Cardiomyopathy in Patients Suffering From Acute Non-traumatic Subarachnoid Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 1
- 主要终点
- urine metanephrine, normetanephrine levels
研究概览
简要总结
Pupose:
Takotsubo cardiomyopathy is a rare and not well-known complication of the subarachnoid hemorrhage.
This form of heart failure, called as "broke heart" or "apical ballooning syndrome", was first described by Japanese authors at the beginning of 1990's.
1.5-2.2% of acute coronary syndrome is Takotsubo cardiomyopathy. Its predisposing factors, hypothetical parthenogenesis, diagnostic criteria and therapeutic methods are already known from the literature.
The study intends to include all patients over 18 years of age who were admitted to our clinic within 48 hours after the bleeding regardless of gender, neurological status or age.
Data to be registered within 24 hours after admittance:
Instruments:
- Intracranial blood flow characteristics:TCCD - using Transcranial Color Doppler; systolic, diastolic and mean blood flow velocity, Systolic / Diastolic ratio, pulsatility index
- ECG abnormalities: Corrected QT Interval (QTc), T wave, ST segment, arrhythmia
- Echocardiography (Ejection fraction%, exact location and degree of cardiac wall motion abnormalities) - documented with video recording
Hypothesis:
The risk of Takotsubo cardiomyopathy (TS) is increased if SAH is associated with more severe state, a greater degree of bleeding, intraventricular and/ or intracerebral hemorrhage.
The definitive care of patients is postponed due to the appearance of TS, which could affect the final outcome.
详细描述
Data to be registered within 24 hours after admittance:
- Age of the patient
- Gender
- Comorbidities
- Currently taken medications
- The exact time point of bleeding
- Additional circumstances of the bleeding
- Physical stress factors
- Psychological stress factors
- Significant blood pressure elevation, and its assumed reason
- Severity of bleeding:Fisher's Grade; Neurological status; Hunt-Hess scale;GCS (Glasgow Coma Scale)
- Intracranial blood flow characteristics:TCCD - using Transcranial Color Doppler; systolic, diastolic and mean blood flow velocity, Systolic / Diastolic ratio, pulsatility index
- Cardiac status:Chest pain, Shortness of breath, Pulmonary edema
- ECG abnormalities: Corrected QT Interval (QTc), T wave, ST segment, arrhythmia
- Enzyme level associated with myocardial tissue necrosis: Cardiac troponin I (cTnI), creatine kinase (CK), CK-MB, Brain natriuretic peptide (BNP), N-terminal prohormone of brain natriuretic peptide (NT-proBNP)
- The amount of urine collected in 24 hours and determination of urine metanephrine, normetanephrine levels
- Chest X-ray
- Echocardiography (Ejection fraction%, exact location and degree of cardiac wall motion abnormalities) - documented with video recording
- Medication: Nimodipine, simvastatin, keeping Mg levels in the normal range, ulcer prophylaxis, painkillers
- Fluid therapy: ensuring normovolaemia
Data to be recorded during hospital stay:
- Localization of the bleeding (is there an aneurysm present, if yes what is its location, size)
- Is ventricular drain necessary?
- Treatment methods of the aneurysm:Endovascular, aneurysm clipping
- Time passed between bleeding and treatment (in hours)
The following investigations are repeated daily:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Acute subarachnoid hemorrhage
- •Admittance to the neurosurgery intensive care unit within 48 hours after the bleeding has occurred
- •Over 18 years of age
- •No prior cardiological diseases in medical history
排除标准
- •Known myocardial diseases (previous myocardial infarction)
- •Preexisting heart failure
- •Previously known structural heart disease (severe, clinically significantvalve insufficiency, and / or significant stenosis)
- •Preexisting myocarditis
- •Preexisting phaecromocytoma
- •Preexisting hypertrophic cardiomyopathy (Left ventricle > 15 mm)
- •Preexisting coronary artery stenosis that requires dilation (patients should be excluded if coronary artery stenosis with dilation need is confirmed during the follow-up period)
结局指标
主要结局
urine metanephrine, normetanephrine levels
时间窗: The following diagnostic steps should be repeated after 1 month
The level of metanephrine and normetanephrine from 24-hour collected urine should be measured again after 1 and 6 months in case of patients where TS was diagnosed.
Enzyme level associated with myocardial tissue necrosis
时间窗: The following diagnostic steps should be repeated after 1 month
Cardiac troponin I (cTnI), creatine kinase (CK), CK-MB, Brain natriuretic peptide (BNP), N-terminal prohormone of brain natriuretic peptide (NT-proBNP)
Ejection fraction%, exact location and degree of cardiac wall motion abnormalities
时间窗: The following diagnostic steps should be repeated after 1 month
Echocardiography documented with video recording
ECG abnormalities:Corrected QT Interval (QTc), T wave, ST segment, arrhythmia
时间窗: The following diagnostic steps should be repeated after 1 month
12-lead ECD
次要结局
- New York Heart Association scores (NYHA scores) Glasgow outcome scale (GOS) - survival index Neurological status(The following examinations should be carried out after 6 months:)
研究者
Tamas Vegh, MD
assistant lecturer anesthesiologist and intensive care specialist
University of Debrecen