New Biomarkers of Neurological Outcome in Patients With Sudden Cardiac Death: Role of Circulating Microparticles
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Change in Glasgow-Pittsburgh Cerebral Performance Categories Scale for neurological outcome.
研究概览
简要总结
The aim of the project is to establish the value of circulating microparticles as a new biomarker for neurological prognosis of patients recovered from sudden cardiac death who remain comatose.
详细描述
This is a pilot study. Analytical, observational, longitudinal, retrospective and prospective, non-randomized. Patients recovered from sudden cardiac death of ischemic cause and remain comatose will be included in the protocol if they fit the pre-specified inclusion criteria. Biological samples will be collected (at admission, at 24 and 72 hours) and stored in the Biobank of Hospital de la Santa Creu i Sant Pau for further analysis. In addition demographic, clinical and analytical variables will be collected. At the end of the recruitment period, we will analyse the concentrations of circulating microparticles according to ICCC-IIBSantPau methodology in the samples obtained. The primary outcome variable will be the neurological status at Coronary Care Unit discharge and at 6 months. The objective of the study will evaluate the relationship between the neurological status and the blood concentrations of circulating microparticles.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Over 18 years old.
- •Patients recovered from a sudden cardiac death (in-hospital and out-of-hospital) with return of spontaneous circulation (ROSC) (defined as systolic blood pressure > 60 mmHg or palpable pulse for > 5 minutes) who remain unconsciousness (defined as a score on the Glasgow Coma Scale <8 ) for > 5-10 minutes after ROSC.
- •Treated with hypothermia as recommended by the European guidelines for resuscitation ( 2010)..
排除标准
- •Non-cardiac sudden death.
- •Active oncologic pathology .
- •Traumatic or spontaneous intra-cranial haemorrhage.
- •Inability to obtain required blood samples or refusal of the informed consent necessary for it.
结局指标
主要结局
Change in Glasgow-Pittsburgh Cerebral Performance Categories Scale for neurological outcome.
时间窗: Change from Glasgow-Pittsburgh Cerebral Performance Categories Scale at 6 months
1. Good cerebral performance: conscious, alert, able to work, might have mild neurologic or psychologic deficit. 2. Moderate cerebral disability: conscious, sufficient cerebral function for independent activities of daily life. Able to work in sheltered environment. 3. Severe cerebral disability: conscious, dependent on others for daily support because of impaired brain function. Ranges from ambulatory state to severe dementia or paralysis. 4. Coma or vegetative state: any degree of coma without the presence of all brain death criteria. Unawareness, even if appears awake (vegetative state) without interaction with environment; may have spontaneous eye opening and sleep/awake cycles. Cerebral unresponsiveness. 5. Brain death: apnea, areflexia, EEG silence, etc.
次要结局
- Cardiovascular mortality(6 months)