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

Cerebral Infarction Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02259738
• Other study ID #: hanying1
• Status: Completed
• Phase: Phase 2
• First received: September 16, 2014
• Last updated: October 4, 2014
• Start date: January 2013
• Est. completion date: June 2014

Study information

• Verified date: October 2014
• Source: Xuanwu Hospital, Beijing
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Infarction
• Infarction

Intervention

Drug:
• Human Urinary Kallidinogenase

• Shuxuening injection

Locations

Country	Name	City	State
China	Department of Neurolgy,Xuanwu Hospital of Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
XuanwuH 2

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perfusion Weighted Imaging	Reflect the infarction center and low perfusion of tissue	7 days	Yes