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Homoarginine Supplementation in Patients After Stroke

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合作者:
信息的提供 (责任方):
July 18, 2018
October 2, 2018
October 2, 2018
August 22, 2018
December 2022   (主要结果测量的最终数据收集日期)
Homoarginine serum concentration[ Time Frame: six month ]
Normalization of homoarginine serum concentration to levels >2.1 umol/L.

与当前相同
  • Intima-media thickness[ Time Frame: six month ]
    Intima-media thickness (IMT) measured at both common carotid arteries using an edge detection system. Plaques are defined as protrusion of ≥1.5 mm in common, internal and external carotid artery.
  • National Institute of Health Stroke Scale[ Time Frame: six month ]
    National Institute of Health Stroke Scale (NIHSS) will be assessed by a neurologist. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 (normal) and 4 (maximum impairment). The maximum possible score is 42, with the minimum score being a 0.
  • Modified Ranking Scale[ Time Frame: six month ]
    Modified Ranking Scale (mRS) is a scale for measuring the degree of disability of a stroke patients. The scale runs from 0 (perfect health) to 6 (death).
 
Homoarginine Supplementation in Patients After Stroke
Homoarginine in Stroke (HiS) Study

This study represents a follow-up of the previous study "Single and Multiple Doses of an Oral Formulation of L-Homoarginine in Healthy Human Subjects" (NCT02675660). This study will evaluate the applicability of an oral formulation of L-homoarginine to normalize homoarginine blood levels in patients with acute ischemic stroke.

Interventional
N/A
分配: Randomized
干预模型: Parallel Assignment
干预模型描述: randomized double-blind placebo controlled
盲法: Interventional
盲法描述:
主要目的: Basic Science
  • Dietary Supplement: 125 mg L-homoarginine
    capsules for oral supplementation
  • Other: placebo
    capsules for oral supplementation
  • Placebo Comparator: placebo
    placebo capsules containing lactose - oral once daily for three days followed by six month once weekly administration
  • Active Comparator: homoarginine
    125 mg L-homoarginine supplement - oral once daily for three days followed by six month once weekly administration
 
Recruiting
500
与当前相同
August 2023
December 2022   (主要结果测量的最终数据收集日期)
Inclusion Criteria: - ischemic stroke (CT or MRI) - serum homoarginine 2.1 umol/L - heart failure (NYHA > 1) - chronic kidney disease (GFR <60 mL/min) - not competent - pregnancy, lactation - no or withdrawn signed informed consent
参与研究的性别: All
最小年龄:18 Years ,最大年龄:N/A  
没有
Germany
 
No
研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No
计划分享 IPD: No
Universitätsklinikum Hamburg-Eppendorf
:
September 2018

ICMJE     国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素
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