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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02259738
Enrollment
120
Registered
2014-10-08
Start date
2013-01-31
Completion date
2014-06-30
Last updated
2014-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Infarction

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.

Interventions

Sponsors

XuanwuH 2
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Perfusion Weighted Imaging7 daysReflect the infarction center and low perfusion of tissue

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026