Back to resultsMulti-modality MRI Study on Effect to Collateral Circulation and Blood Perfusion of Acute Cerebral Infarction by Human Urinary Kallidinogenase
Primary Purpose
Cerebral Infarction
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Human Urinary Kallidinogenase
Shuxuening injection
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Infarction
Eligibility Criteria
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.
Sites / Locations
- Department of Neurolgy,Xuanwu Hospital of Capital Medical University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Human urinary kallidinogenase and Shuxuening injection
Arm Description
Human urinary kallidinogenase 0.15PNA and Shuxuening injection 20mg, every day for 7 days.
Outcomes
Primary Outcome Measures
Perfusion Weighted Imaging
Reflect the infarction center and low perfusion of tissue
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02259738
Brief Title
Multi-modality MRI Study on Effect to Collateral Circulation and Blood Perfusion of Acute Cerebral Infarction by Human Urinary Kallidinogenase
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
XuanwuH 2
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Human urinary kallidinogenase and Shuxuening injection
Arm Type
Experimental
Arm Description
Human urinary kallidinogenase 0.15PNA and Shuxuening injection 20mg, every day for 7 days.
Intervention Type
Drug
Intervention Name(s)
Human Urinary Kallidinogenase
Other Intervention Name(s)
youruikelin
Intervention Type
Drug
Intervention Name(s)
Shuxuening injection
Primary Outcome Measure Information:
Title
Perfusion Weighted Imaging
Description
Reflect the infarction center and low perfusion of tissue
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Department of Neurolgy,Xuanwu Hospital of Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
12. IPD Sharing Statement
Learn more about this trial
Multi-modality MRI Study on Effect to Collateral Circulation and Blood Perfusion of Acute Cerebral Infarction by Human Urinary Kallidinogenase
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