Effects of Urinary Kallidinogenase in Acute Ischemic Stroke Patients With Abnormal Glucose Metabolism

NCT04020666 | Completed

• 1 other identifier: 2016261
• Study Type: observational
• Target: 113
• Locations: 0 countries
• Sites: N/A

Brief Summary

Urinary kallidinogenase may assist recovery acute ischemic stroke. This study evaluated the impact of urinary kallidinogenase on NIHSS score, modified Rankin scale (mRS) score and fasting glucose levels in patients with AIS combined with diabetes mellitus and impaired fasting glucose.

Conditions

Acute Ischemic Stroke; Abnormal Glucose Metabolism

Outcome Measures

Primary Outcomes (1)

• NIHSS Score at 90 Days

  Comparison of NIHSS score between the control and HUK group at 90 days

  at 90 days after admission

Secondary Outcomes (4)

• NIHSS Score at 10 Days、30 Days

  at 10 days, 30 days after admission

• Factors related to Non-General Recovery (90-day NIHSS was reduced by <90%)

  at 90 days after admission

• mRS Score

  10 days, 30 days, and 90 days after admission

• fasting glucose levels

  at admission and 10 days after admission

Study Arms (2)

HUK group

On the basis of routine treatment for cerebral infarction, patients in the HUK group were also given Urinary Kallidinogenase at 0.15 PNA unit/day, for a 10-day course.

Drug: Urinary Kallidinogenase

control group

The control group were given routine treatment for cerebral infarction, including anti-platelet aggregation, anticoagulation, lipid-lowering and plaque stabilizing, free radical scavenging, nerve nutrition and brain protection.

Interventions

Urinary Kallidinogenase DRUG

Also known as: Kai Li Kang

HUK group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with AIS combined with diabetes mellitus and impaired fasting glucose who was meets the Inclusion and Exclusion Criteria were enrolled in this prospective cohort study and divided into two groups.

You may qualify if:

• Aged 18-75 years (male or female)
• Patients were admitted to hospital within 72h of stroke onset
• Diagnosis of acute ischemic stroke according to the criteria stated in the Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke in China (2010), and patients were confirmed as acute ischemic cerebrovascular disease by head computed tomography (CT) or magnetic resonance imaging (MRI) and diffusion weighted imaging (DWI)
• NIHSS score ranged from 3-21 points
• Patients were previously diagnosed with type 2 diabetes, in which they were in line with the 2006 WHO diagnostic criteria for diabetes, or they had fasting blood glucose of 6.1-6.9mmol/L and glycosylated hemoglobin (HbA1C) of\>6.1%
• Patients could cooperate with the test and evaluation of relevant indicators in the trial.

You may not qualify if:

• Pregnant or lactating women
• Patients with severe heart, liver and kidney dysfunction
• Patients with a history of cerebrovascular disease and who still suffered from serious neurological dysfunction that had an influence on the trial
• Patients with physical disabilities, joint deformities or muscle lesions
• Patients were confirmed with intracranial hemorrhage by CT
• Patients were allergic to the study drug
• Patients suffering from severe systemic infection
• Patients who had participated in other clinical trials within 1 month
• For any reason, the researchers believed that the subject was unlikely to complete the study (such as cerebral infarction caused by cerebral embolism, intracranial arteritis, cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL) and moyamoya disease; patients undergoing thrombolysis or thrombectomy after admission; patients and their families were unable to cooperate with follow-up.)

Sponsors & Collaborators

• The Second Hospital of Hebei Medical University: lead

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Xiaopeng Wang, MD

  The Second Hospital of Hebei Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 16, 2019
• Study Start: December 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: July 16, 2019

Record last verified: 2016-12