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

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ClinicalTrials.gov Identifier: NCT04020666
Recruitment Status : Completed
First Posted : July 16, 2019
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
The Second Hospital of Hebei Medical University

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.

Condition or disease Intervention/treatment
Acute Ischemic Stroke Abnormal Glucose Metabolism Drug: Urinary Kallidinogenase

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 113 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Actual Study Start Date : December 2016
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Group/Cohort Intervention/treatment
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
Other Name: Kai Li Kang

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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04020666


Sponsors and Collaborators
The Second Hospital of Hebei Medical University
Investigators
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Principal Investigator: Xiaopeng Wang, MD The Second Hospital of Hebei Medical University

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Responsible Party: The Second Hospital of Hebei Medical University
ClinicalTrials.gov Identifier: NCT04020666     History of Changes
Other Study ID Numbers: 2016261
First Posted: July 16, 2019    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: December 2016

Additional relevant MeSH terms:
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Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Kallikreins
Coagulants
Fertility Agents, Male
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs