NCT03334968

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 7, 2017

Completed
Last Updated

November 9, 2017

Status Verified

November 1, 2017

Enrollment Period

1 year

First QC Date

November 4, 2017

Last Update Submit

November 7, 2017

Conditions

Keywords

Strokeprolidaseprognosisbiomarker

Outcome Measures

Primary Outcomes (1)

  • Serum prolidase enzyme activity measurement

    Evaluation of serum prolidase enzyme activity in stroke patients and control group

    24 hours

Study Arms (2)

Patient group

Acute ischemic stroke patients

Control group

Those served as control group

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients WHO were evaluated in the tertiary care clinic

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem University

Istanbul, Fatih, Turkey (Türkiye)

Location

Related Publications (7)

  • Gonullu H, Aslan M, Karadas S, Kati C, Duran L, Milanlioglu A, Aydin MN, Demir H. Serum prolidase enzyme activity and oxidative stress levels in patients with acute hemorrhagic stroke. Scand J Clin Lab Invest. 2014 Apr;74(3):199-205. doi: 10.3109/00365513.2013.873949. Epub 2014 Jan 23.

  • Verma AK, Raj J, Sharma V, Singh TB, Srivastava S, Srivastava R. Plasma Prolidase Activity and Oxidative Stress in Patients with Parkinson's Disease. Parkinsons Dis. 2015;2015:598028. doi: 10.1155/2015/598028. Epub 2015 Aug 9.

  • Tabur S, Oguz E, Eren MA, Korkmaz H, Savas E, Aksoy N, Sabuncu T. Serum prolidase activity is associated with non-diabetic metabolic syndrome. Diabetol Metab Syndr. 2014 Dec 17;6(1):142. doi: 10.1186/1758-5996-6-142. eCollection 2014.

  • Gasche Y, Copin JC, Sugawara T, Fujimura M, Chan PH. Matrix metalloproteinase inhibition prevents oxidative stress-associated blood-brain barrier disruption after transient focal cerebral ischemia. J Cereb Blood Flow Metab. 2001 Dec;21(12):1393-400. doi: 10.1097/00004647-200112000-00003.

  • Myara I, Charpentier C, Lemonnier A. Optimal conditions for prolidase assay by proline colorimetric determination: application to iminodipeptiduria. Clin Chim Acta. 1982 Oct 27;125(2):193-205. doi: 10.1016/0009-8981(82)90196-6.

  • CHINARD FP. Photometric estimation of proline and ornithine. J Biol Chem. 1952 Nov;199(1):91-5. No abstract available.

  • Danton GH, Dietrich WD. Inflammatory mechanisms after ischemia and stroke. J Neuropathol Exp Neurol. 2003 Feb;62(2):127-36. doi: 10.1093/jnen/62.2.127.

MeSH Terms

Conditions

Ischemic StrokeProlidase DeficiencyStroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin AbnormalitiesAmino Acid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornSkin Diseases, Genetic

Study Officials

  • Abdulkadir TUNÇ, MD

    Bezmialem Vakif University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neurologist

Study Record Dates

First Submitted

November 4, 2017

First Posted

November 7, 2017

Study Start

May 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

November 9, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations