Cytokine Registry Database of Stroke Patients

NCT03297827 | Completed

• 1 other identifier: 17-315
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Various molecules (cytokines: interleukins, interferons and neural proteins) found in human and animal blood are reported to be elevated in acute stroke (Ischemic and hemorrhagic). Cytokines can be pro-inflammatory or anti-inflammatory. There are studies confirming level changes in serum of humans in the setting of several rheumatologic and cardiovascular diseases. As new molecular markers (cytokines and neural tissue markers) are established in scientific literature, stroke scientists are interested to evaluate the role of these in the pathophysiology of stroke. Investigators intend to study the role of these molecules in the development of stroke. Acute stroke treatment has advanced considerably in the last 10 years with the establishment of comprehensive stroke centers and approval of neuro-interventional techniques. However, the molecular advancement in stroke pathogenesis has yet to reach a milestone in the world of stroke treatment. In our opinion, creating a database of acute stroke patients containing all pertinent medical demographics and clinical information along with the laboratory data, molecular levels of pertinent cytokines/neural factors from consenting patients, will help us define and delineate the most relevant molecules that are altered in acute stroke patients and can help us further improve us understanding of the role of these in acute stroke and thereby hopefully help in the improvement of our understanding and management of stroke. Moreover, analyzing the cytokines in stroke and ICH patients would help understand their role in the acute phase, which may become potential therapeutic adjuncts for tPA and endovascular thrombectomy.

Conditions

Acute Stroke; Acute Ischemic Stroke; Ischemic Stroke; Hemorrhagic Stroke

Keywords

diagnosis; inflammatory biomarkers; cytokines; interleukin; interferons

Outcome Measures

Primary Outcomes (1)

• Change in the cytokine levels at the 24-hour mark from the baseline levels done at the time of admission for acute stroke.

  Investigators will assess the variations in the levels of cytokines and inflammatory biomarkers at the 24-hour mark from the baseline levels done at the time of admission for acute stroke. Their correlation with each other may enable investigators to identify and streamline their efforts on only a few cytokines, interleukins, glial factors or metabolic products proved to be altered in acute stroke patients.

  24 Hours

Study Arms (2)

Patients with stroke

Adult stroke patients with the stroke diagnosis will be recruited on admission to the University of New Mexico Hospital. Serum and Urine measurement of cytokines from two sets of serum and urine samples will be done on the admission and at the 24-hour mark respectively, form the specimens collected for the clinical purposes and are meant to be discarded. Consent will be taken from the patients to use these samples for our study.

Other: Serum and Urine measurement of cytokines.

Patients without stroke

Age/Sex matched adult control patients without the diagnosis of stroke, myocardial infarction, inflammatory flare, acute trauma, neurodegenerative or neuroinflammatory disease (AD, PD, TM, PSP, etc.) except MS will be recruited on admission to the University of New Mexico Hospital. Serum and Urine measurement of cytokines from two sets of serum and urine samples will be done on the admission and at the 24-hour mark respectively, form the specimens collected for the clinical purposes and are meant to be discarded. Consent will be taken from the patients to use these samples for our study.

Other: Serum and Urine measurement of cytokines.

Interventions

Serum and Urine measurement of cytokines. OTHER

To evaluate serum cytokine levels and identifying serum inflammatory markers (serum interleukin-33, IL-37, IL-36, IL-4, IL-6, IL-10, IL-17, IL-23, IL-1, TNF, PDGF, VEGFM TNFa, ANNULIN, MMP-9, MMP-12, NFk-B levels plus metabolic products like MPO, etc and glial factors like GMF, SI000B, GM6001) in patients with acute ischemic \& hemorrhagic stroke.

Patients with stroke; Patients without stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Two sets of serum samples will be obtained and analyzed; one upon admission to the hospital, and the 2nd, the next morning after overnight fasting. Both sets of blood draw are done for a clinical purpose, and any extra stored sample that is drawn and not used by pathology will be used for the study. Twenty-five percent of the total stroke patient serum samples will be matched by appropriate controls to confirm the level changes in stroke patients. ELISA-PCR assays will be performed on serum samples.

You may qualify if:

• All stroke patients (hemorrhagic and ischemic) presenting within 24 hours of onset who consent to our study.
• Adult Male/Female patients ages \>18 years old
• Patients whose standard stroke admission order sets are obtained for clinical care.
• Patients with a history of MS may be included for future subanalysis.

You may not qualify if:

• History of prior stroke or any other neurodegenerative or neuroinflammatory disease (AD, PD, TM, PSP, etc.) except MS.
• Individuals ages \<18 year
• Pregnant women
• Prisoners

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

Department of Neurology, University of New Mexico

Albuquerque, New Mexico, 87131-0007, United States

Location

Related Publications (3)

• Zafar A, Farooqui M, Ikram A, Suriya S, Kempuraj D, Khan M, Tasneem N, Qaryouti D, Quadri S, Adams HP, Ortega-Gutierrez S, Leira E, Zaheer A. Cytokines, brain proteins, and growth factors in acute stroke patients: A pilot study. Surg Neurol Int. 2021 Jul 27;12:366. doi: 10.25259/SNI_569_2021. eCollection 2021.

  PMID: 34513133 RESULT

• Farooqui M, Ikram A, Suriya S, Saleem S, Quadri SA, Robinson M, Ortega-Gutierrez S, Qeadan F, Leira E, Paul S, Zafar A. Cytokine Registry In Stroke Patients (CRISP): Protocol of a prospective observational study. Medicine (Baltimore). 2020 Jul 10;99(28):e20921. doi: 10.1097/MD.0000000000020921.

  PMID: 32664088 DERIVED

• Zafar A, Ikram A, Jillella DV, Kempuraj D, Khan MM, Bushnaq S, Adam H, Ortega-Gutierrez S, Quadri SA, Farooqui M, Zaheer A, Leira EC. Measurement of Elevated IL-37 Levels in Acute Ischemic Brain Injury: A Cross-sectional Pilot Study. Cureus. 2017 Oct 11;9(10):e1767. doi: 10.7759/cureus.1767.

  PMID: 29234571 DERIVED

Related Links

• Cytokines, brain proteins, and growth factors in acute stroke patients: A pilot study

Biospecimen

Retention: SAMPLES WITH DNA

Blood Specimens Urine Specimens

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Hemorrhagic Stroke; Disease

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michel Torbey, MD, MPH

  University of New Mexico

  STUDY CHAIR

• Atif Zafar, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

• Asad Ikram, MD

  University of New Mexico

  STUDY DIRECTOR

• Mudassir Farooqui, MD, MPH

  University of New Mexico

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2017
• First Posted: September 29, 2017
• Study Start: May 15, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 8, 2022

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)