Assessment of Therapeutic Role of H2S Donor in Acute Myocardial Infarction and Acute Cerebral Ischemia: Comparison in Animal Models and Clinical Cases.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Detect the effect of oral administration of NAC in critically ill acute ischemic stroke patients on the functional outcome.
研究概览
简要总结
- Clarify novel systemic and local inflammatory mechanisms underlying the cross talk between brain and heart ischemic states,
- Investigate the new aspects of NAC beyond traditional therapy, in cerebral and myocardial ischemic conditions, both in animal models and clinical cases.
详细描述
The study was conducted on 121 adult acute ischemic stroke patients admitted to stroke unit; either intermediate care or intensive care, of Kasr El Ainy Medical Hospital, Cairo University. Five patients were excluded as they didn't meet our eligibility criteria.
Oral form of NAC was given. Patients were divided into 4 groups:
- Group I (AIS-IHD): critically ill AIS patients who had past history and / or current evidence of IHD (30 patients), Without administration of NAC (as a control group).
- Group II (AIS-IHD-NAC): critically ill AIS patients who had past history and / or current evidence of ischemic heart disease (IHD) (30 patients), With nasogastric or oral administration of NAC.
- Group III (AIS-NON-IHD): critically ill AIS patients who had Neither past history Nor current evidence of IHD (27 patients), Without administration of NAC (as a control group).
- Group IV (AIS-NON-IHD-NAC): critically ill AIS patients who had Neither past history Nor current evidence of IHD (29 patients), With nasogastric or oral administration of NAC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Lab Technicians
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 above 18 years
- •AIS patients admitted into stroke unit
- •Onset within 48 hours
- •Glasgow coma scale (GCS) ≥ 8
- •Out of window or contraindicated for thrombolytics
- •Not arrested before
排除标准
- •Age below 18 years
- •Cerebral haemorrhage
- •Dural sinus thrombosis
- •Glasgow coma scale (GCS) < 8
- •Patients received thrombolytic
- •Post arrest
研究组 & 干预措施
Group I (AIS-IHD)
critically ill AIS patients who had past history and / or current evidence of IHD (30 patients), With oral saline administration (as a control group).
干预措施: Normal (0.9%) saline (Drug)
Group II (AIS-IHD-NAC)
critically ill AIS patients who had past history and / or current evidence of ischemic heart disease (IHD) (30 patients), With nasogastric or oral administration of NAC.
干预措施: N Acetyl cysteine 600mg (Drug)
Group III (AIS-NON-IHD)
critically ill AIS patients who had Neither past history Nor current evidence of IHD (27 patients), With oral saline administration (as a control group).
干预措施: Normal (0.9%) saline (Drug)
Group IV (AIS-NON-IHD-NAC)
critically ill AIS patients who had Neither past history Nor current evidence of IHD (29 patients), With nasogastric or oral administration of NAC.
干预措施: N Acetyl cysteine 600mg (Drug)
结局指标
主要结局
Detect the effect of oral administration of NAC in critically ill acute ischemic stroke patients on the functional outcome.
时间窗: At admission (on day 1), after 3 days (on day 4), and at discharge from hospital (up to day 30).
This outcome was assessed by evaluation of Glasgow Coma Score, the minimum and the worst = 3, and the maximum and the best = 15. It depends on assessment of Eye opening, Verbal response, Motor response. Also, evaluation of Modified Rankin Scale, for measuring the degree of disability following stroke, the maximum and the worst = 6, the minimum and the best = 0. Furthermore, evaluation of National Institutes of Health Stroke Scale (NIHSS), the most widely used functional assessment score for stroke, the maximum and the worst = 42, and the minimum and the best = 0. It depends on assessment of various clinical aspects, e.g., consciousness, orientation, vision, gaze, fascial palsy, speech, motor power, coordination, and sensation.
次要结局
- Detect the effect of oral administration of NAC in critically ill acute ischemic stroke patients on the inflammatory storm and autophagy markers.(At admission (on day 1) and after 3 days (on day 4).)
研究者
Mahmoud Mousad
Assistant Lecturer Master Degree
Helwan University