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Reperfusion Injury After Stroke Study

NCT03041753 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 140

Last updated 2017-02-03

No results posted yet for this study

Summary

Background: stroke is a major cause of death and disability. Intravenous thrombolysis and mechanical thrombectomy are able to re-open occluded vessels and save the ischemic tissue from death. However, recanalization of the occluded vessel may trigger activation of detrimental molecular pathways and exacerbate blood brain barrier (BBB) disruption, eventually determining hemorrhagic transformation (HT) or cerebral edema (CE), causing the so-called "reperfusion injury". There is increasing evidence that a number of factors measurable as circulating biomarkers, particularly metalloproteinases (MMP), contribute to reperfusion brain injury. Preliminary data show that BBB disruption can be traced in vivo by Computed Tomography Perfusion (CTP) imaging. The aim of this study is to evaluate the effects of circulating and imaging biomarkers in relation to reperfusion injury.

Methods: consecutive patients presenting with acute ischemic stroke in the anterior circulation territory, scoring≥7 on NIHSS, candidates to intravenous thrombolysis or to endovascular treatment, will be enrolled in one hospital centre. Circulating levels of pro-, anti-inflammatory, immunomodulatory factors, metalloproteinases and their inductors/inhibitors, factors of endothelial dysfunction and fibrin resistance to lysis will be measured in blood samples taken from each patients pre-thrombolysis and 24 hours after thrombolysis. Biomarker levels will be studied in relation to CTP measures of BBB permeability and in relation to imaging signs of reperfusion injury after acute interventions, such as hemorrhagic transformation and cerebral edema.

Results: enrollment started on October 2015. As of January 2017, 70 patients have been included. Results are expected by the end of 2018 with an estimated sample size of 140 patients. Using a definite protocol, a prospective collection of data, and an adequate number of patients assuring statistically powered data, this study will integrate clinical information with imaging and biological factors involved in reperfusion injury after cerebral ischemia.

Conditions

Sponsors & Collaborators

  • Ministry of Health, Italy

    collaborator OTHER_GOV

  • Azienda Ospedaliero-Universitaria Careggi

    lead OTHER

Principal Investigators

  • Domenico Inzitari, MD · University of Florence

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2018-08-31
Completion
2018-11-30

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03041753 on ClinicalTrials.gov