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Completed

NCT Number: NCT02259738

Multi-modality MRI Study on Effect to Collateral Circulation and Blood Perfusion of Acute Cerebral Infarction by Human Urinary Kallidinogenase

Human urinary kallidinogenase can promote the establishment of collateral circulation in the ischemic penumbra due to the stenosis or occlusion of middle cerebral artery and then increase the perfusion.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Neurolgy,Xuanwu Hospital of Capital Medical University

Beijing, Beijing Municipality, 100053, China

About this study

Patients with acute ischemic stroke will be given human urinary kallidinogenase .Then we will estimate the cerebral collateral circulation in ischemic regions and final infarct volume, comparing with traditional therapy such as Shuxuening injection, which will provide new evidence for the treatment of ischemic stroke. Perfusion Weighted Imaging(PWI) could be a method to reflect the infarction center and low perfusion of tissue.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age:greater than or equal to 18 years old and less than or equal to 70 years old;
  • Time of onset is less than 7 days;
  • Acute cerebral infarction due to the stenosis or occlusion of middle cerebral artery diagnosed by CT or MRI;
  • The National Institute of Health Stroke Scale(NIHSS) score is 4 to 20;
  • Excluding intracranial hemorrhage using CT or MRI.

Exclusion criteria

  • The NIHSS score is less than or equal to 3;
  • Patients with cerebral aneurysm, cerebral hemorrhage, brain tumor, brain contusion and laceration of brain and other diseases;
  • Intracranial hemorrhage displaying by CT or MRI; Cardiac insufficiency;
  • Cardiac insufficiency;
  • Chronic liver disease(A/G inversion),elevated alanine aminotransferase(ALT)(more than 1.5 times the normal value);
  • Increased serum creatinine(more than 1.5 times the normal value);
  • Poorly controlled diabetes;
  • Recently suffered from hemorrhagic disease or bleeding tendency;
  • Recent use of angiotensin-converting enzyme inhibitor (ACEI) drugs;
  • Allergic constitution and had a variety of drug allergy history;
  • Women in period of pregnancy or lactation.

Treatment and study plan

Human Urinary Kallidinogenase

Drug

Other names: youruikelin

Shuxuening injection

Drug

Primary outcomes

  1. Perfusion Weighted Imaging

    Time frame: 7 days

    Reflect the infarction center and low perfusion of tissue

Sponsors and collaborators

Lead sponsor

XuanwuH 2

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 8, 2014
Registry last updated
Oct 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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