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

October 4, 2014 updated by: XuanwuH 2
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100053
        • Department of Neurolgy,Xuanwu Hospital of Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Human urinary kallidinogenase and Shuxuening injection
Human urinary kallidinogenase 0.15PNA and Shuxuening injection 20mg, every day for 7 days.
Drug: Human Urinary Kallidinogenase
Other Names:
  • youruikelin
Drug: Shuxuening injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perfusion Weighted Imaging
Time Frame: 7 days
Reflect the infarction center and low perfusion of tissue
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

XuanwuH 2

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

September 16, 2014

First Submitted That Met QC Criteria

October 4, 2014

First Posted (Estimate)

October 8, 2014

Study Record Updates

Last Update Posted (Estimate)

October 8, 2014

Last Update Submitted That Met QC Criteria

October 4, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • hanying1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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