Acute Ischemic Stroke Clinical Trial
Official title:
Evaluation Of Human Urinary Kallidinogenase in Acute Stroke Patients: Magnetic Resonance Spectrum and CT Perfusion
Verified date | November 2017 |
Source | Xuanwu Hospital, Beijing |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background: Acute ischemic stroke (AIS) is a leading cause of morbidity and mortality
worldwide. Human urinary kallidinogenase (HUK), a glycoprotein extracted from male urine
currently used in China for enhancing cerebral perfusion5, plays a neuroprotective role
including promoting angiogenesis, enhancing cerebral perfusion and suppressing the
inflammatory response in animals and in patients with respect to regulating the
kallikrein-kinin system. In previous clinical research, neurological function scores and
cerebral perfusion scans were largely used to evaluate the efficiency of HUK. However, the
mechanisms of Further well-conducted, randomized controlled studies using HUK are currently
lacking.
Objective: To assess the Human urinary kallidinogenase effects on brain metabolite and
cerebral perfusion changes using magnetic resonance spectroscopy and CT perfusion in patients
with AIS.
Methods: The investigators plan to do a single-centre randomized, double-blind, controlled
trial in which ischemic stroke patients will be randomized to treatment with either HUK or
regular treatment within 72 hours of symptom onset. The study includes two MRS and two CTP
scannings (before and after 2 week treatment) for all randomized subjects.
The endpoints will include improvement of the NIH Stroke Scale (NIHSS) score from baseline,
modified Rankin scale (mRS) score and Barthel index at 14 days.
EvHUKMRS will test the following hypotheses:
1. HUK enhanced N-acetylaspartate (NAA) and cerebral blood flow (CBF) 14 days after
treatment compared with control group.
2. HUK group compared to control group when administered 72 hours after onset of AIS
improves recovery and functional outcome as assessed by improvement of NIHSS score , mRS
score and BI score on day 14 post-stroke.
A positive result will have a significant impact in the management of AIS and pave the way
for future studies aimed at finding the optimal dose and formulation of HUK for treating
acute ischemic stroke.
Status | Completed |
Enrollment | 80 |
Est. completion date | October 1, 2016 |
Est. primary completion date | October 1, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - ages ranging from 18 to 80 years - onset time less than 72 h, NIHSS score =4; Exclusion Criteria: - TIA - patients with contraindication of venous thrombolysis - patients with encephalic bleeding disorder - patients with incomplete hepatic and renal function - patients with a medical history of peptic ulcer, haemorrhagic stroke, brain tumour or brain trauma - patients who could not coordinate with an MRS scan and - patients with vertebral basilar artery system infarction. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Xuanwu Hospital, Beijing |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | N-acetylaspartate as measured on Magnetic Resonance Spectrum study on admission | NAA Admit | 14 days | |
Primary | Creatine as measured on Magnetic Resonance Spectrum study on admission | Cr Admit | 14 days | |
Primary | Cholineas measured on Magnetic Resonance Spectrum study on admission | Cho | 14 days | |
Secondary | The proportion of mordified Rankin Scale | 14 days | ||
Secondary | The proportion of NIHSS | 14 days | ||
Secondary | The proportion of mRS | 14 days | ||
Secondary | Cerebral blood flow as measured on CT perfusion study on admission | CBF Admit | 14 days | |
Secondary | Cerebral blood volume as measured on CT perfusion study on admission | CBV Admit | 14 days | |
Secondary | Mean transit time as measured on CT perfusion study on admission | MTT Admit | 14 days | |
Secondary | Time to peak as measured on CT perfusion study on admission | TTP Admit | 14 days |
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