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Prolidase Enzyme Activity in Stroke Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03334968
First Posted: November 7, 2017
Last Update Posted: November 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Abdulkadir Tunc, Bezmialem Vakif University
  Purpose
Stroke is a major cerebrovascular disease that causes significant burdens for human health and life, including high morbidity, mortality, and disability. Prolidase enzyme activity was found in various organs, such as the heart, brain, thymus, kidney, lung, pancreas, and spleen, and in plasma, leukocytes, erythrocytes, and dermal fibroblasts. An increase in collagen turnover is known to be correlated with increased prolidase enzyme activity. The aim of this study was to investigate whether SPA levels in AIS patients can be used as a potential diagnostic and prognostic marker. SPA levels were prospectively evaluated in 37 patients aged between 20 and 85 years who were admitted within 24 hours of the onset of AIS. The control group included 37 healthy volunteers of similar age without any disease.

Condition
Stroke, Ischemic Prolidase Deficiency

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Serum Prolidase Enzyme Activity as a Diagnostic Marker for Acute Ischemic Stroke

Resource links provided by NLM:


Further study details as provided by Abdulkadir Tunc, Bezmialem Vakif University:

Primary Outcome Measures:
  • Serum prolidase enzyme activity measurement [ Time Frame: 24 hours ]
    Evaluation of serum prolidase enzyme activity in stroke patients and control group


Enrollment: 74
Actual Study Start Date: May 1, 2016
Study Completion Date: May 1, 2017
Primary Completion Date: May 1, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patient group
Acute ischemic stroke patients
Control group
Those served as control group

Detailed Description:
Ischemic stroke constitutes about 80-85% of all stroke cases and is caused by the interruption of cerebral blood flow due to a blood clot. Because of reactive oxygen species (ROS) production and its oxidative metabolite activity, the brain is highly sensitive to oxidative stress. This characteristic plays an important role in the pathogenesis of ischemic and hemorrhagic brain injuries .Prolidase, which is a cytosolic exopeptidase and a member of the matrix metalloproteinase (MMP) family, cleaves iminodipeptides from carboxy-terminal ends of proline or hydroxyproline and is actively involved in collagen metabolism. It has been shown that brain MMP activity is correlated with nutritive/oxidative stress and increases during reperfusion. Furthermore, in stroke patients, elevated serum MMP levels have been reported. Biomarkers that predict the outcome and occurrence of ischemic stroke are critically important for prevention and treatment .However, serum prolidase activity (SPA) has not been previously assessed in acute ischemic stroke (AIS) patients to our knowledge. Therefore, in this study, it's aimed to investigate whether SPA levels in AIS patients can be used as a potential diagnostic and prognostic marker.In the study, 37 patients aged between 20 and 85 years who were admitted within 24 hours of the onset of AIS were prospectively evaluated. The control group consisted of 37 healthy volunteers of similar age without any disease. A comprehensive physical examination was performed consisting of a neurological examination, blood biochemistry and blood count tests, electrocardiography, and a posterior-anterior chest X-ray for all patients. AIS patients underwent transthoracic echocardiography, multi-slice computed tomography (CT), and bilateral carotid-vertebral artery Doppler ultrasonography. National Institutes of Health Stroke Scale (NIHSS) scores, measured at 24 hours, 48 hours, and 28 days after stroke, were used to determine stroke severity.Ischemic stroke subtypes classification was done according to the Trial of Org 10172 in Acute Stroke Treatment (TOAST) criteria, as cardioembolism, large-artery atherosclerosis, small artery occlusion, stroke of other determined cause, or undetermined cause. The measurement method for SPA was defined by Myara et al. The optimized method of Özcan et al. was used. Prolidase activity was evaluated with a spectrophotometric method, by measuring the proline levels. Briefly, 500 μL pre-incubation solution (50 mmol/L Tris hydrochloride buffer at power of hydrogen (pH) 7.8, with 1 mmol/L endogenous antioxidant glutathione (GSH), 5 mmol/L manganese(II) chloride (MnCl2), and 0.1% Triton X-100) and 100 μL serum were mixed; this mixture was then pre-incubated for 3 h at 37°C. A 100-μL volume of pre-incubation serum was added to 100 μL 144 mmol/L Gly-Pro solution, and this mixture was incubated for 30 min at 37°C. After the incubation, 1 ml 0.45 mol/L Trichloroacetic acid solution was added quickly to the incubation tube, and the incubation reaction was stopped. This mixture was centrifuged at 1500 rpm for 5 min, and 500 μL supernatant was removed.
  Eligibility

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
patients WHO were evaluated in the tertiary care clinic
Criteria

Inclusion Criteria:

  • aged between 20 and 85
  • admitted within 24 hours of the onset of acute ischemic stroke

Exclusion Criteria:

  • patients with heart disease (such as myocardial infarction or heart failure
  • chronic obstructive pulmonary disease,
  • pulmonary embolism,
  • pulmonary hypertension,
  • tuberculosis,
  • lung cancer,
  • chronic renal failure,
  • current hormone replacement treatment.
  Contacts and Locations
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): NCT03334968


Locations
Turkey
Bezmialem University
İstanbul, Fatih, Turkey
Sponsors and Collaborators
Bezmialem Vakif University
Investigators
Principal Investigator: Abdulkadir TUNÇ, MD Bezmialem Vakif University
  More Information

Publications:
Responsible Party: Abdulkadir Tunc, Neurologist, Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT03334968     History of Changes
Other Study ID Numbers: StrokeProlidase
First Submitted: November 4, 2017
First Posted: November 7, 2017
Last Update Posted: November 9, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Abdulkadir Tunc, Bezmialem Vakif University:
Stroke
prolidase
prognosis
biomarker

Additional relevant MeSH terms:
Stroke
Ischemia
Prolidase Deficiency
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Abnormalities, Multiple
Congenital Abnormalities
Skin Abnormalities
Amino Acid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Skin Diseases, Genetic