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NCT Number: NCT04020666

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

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.

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Key information

Conditions

Acute Ischemic Stroke Abnormal Glucose Metabolism Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

About this study

Patients with AIS and abnormal glucose metabolism were enrolled in this prospective cohort study and divided into two groups. The HUK group were treated with urinary kallidinogenase and standard treatment, the control group received standard treatment. NIHSS scores, mRS scores and fasting blood glucose were evaluated and compared.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.)

Treatment and study plan

Urinary Kallidinogenase

Drug

Other names: Kai Li Kang

Primary outcomes

  1. NIHSS Score at 90 Days

    Time frame: at 90 days after admission

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

Secondary outcomes

  1. NIHSS Score at 10 Days、30 Days

    Time frame: at 10 days, 30 days after admission

    Comparison of NIHSS score between the control and HUK group at 10days、30days.

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

    Time frame: at 90 days after admission

    Based on NIHSS score，multivariate analysis was performed to evaluate the factors related to non-general recovery (90-day NIHSS was reduced by <90%) for all patients.

    Evaluation of NIHSS score: General recovery was when NIHSS score was reduced by 90%-100%; Non-general recovery referred to when NIHSS score was reduced by <90%.

  3. mRS Score

    Time frame: 10 days, 30 days, and 90 days after admission

    The mRS score of 10 days after admission was taken as the baseline.Comparison of mRS score between the control and HUK group at 30days、90days.

    Based on mRS，multivariate analysis was also performed to evaluate the factors related to poor curative effect (90-day mRS ≥3) for all patients.

    Evaluation of mRS score: mRS score of 0-2 points referred to a good curative effect, and 3-5 points referred to a poor curative effect.

  4. fasting glucose levels

    Time frame: at admission and 10 days after admission

    Comparison of the change in fasting glucose levels between the control and HUK group at admission and 10days.

Sponsors and collaborators

Lead sponsor

The Second Hospital of Hebei Medical University

Other

Registry information

Official study title

Effects of Urinary Kallidinogenase on NIHSS Score, mRS Score, and Fasting Glucose Levels in Acute Ischemic Stroke Patients With Abnormal Glucose Metabolism: a Prospective Cohort Study

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 16, 2019
Registry last updated
Jul 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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