Reperfusion Injury After Stroke Study (RISKS)
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|ClinicalTrials.gov Identifier: NCT03041753|
Recruitment Status : Unknown
Verified February 2017 by Domenico Inzitari, University of Florence.
Recruitment status was: Recruiting
First Posted : February 3, 2017
Last Update Posted : February 3, 2017
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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||140 participants|
|Official Title:||Reperfusion Injury After Cerebral Ischemia: an "in Vivo" Study Using Neuro-imaging Markers|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||November 2018|
ischemic stroke patients in the anterior circulation territory (NIHSS ≥7) within 12 hours from last seen well, treated either with systemic thrombolysis or endovascular treatment.
- Number of patients with hemorrhagic transformation (type 2 OR any type of parenchyma hemorrhage according to ECASS II criteria) OR cerebral edema (comprising at least 1/3 of the hemisphere OR causing midline shift) at 24h CT [ Time Frame: 24 hours from symptom onset ]Relevant Hemorrhagic Transformation OR Relevant Cerebral Edema
- Categorical shift in mRS score at 3 months [ Time Frame: 3 months from symptom onset ]
- Symptomatic hemorrhagic transformation [ Time Frame: 24 hours from symptom onset ]any deterioration in NIHSS score or death combined with intracerebral hemorrhage of any type
Biospecimen Retention: Samples Without DNA
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): NCT03041753
|Contact: Domenico Inzitari, MDemail@example.com|
|Contact: Benedetta Piccardi, MDfirstname.lastname@example.org|
|Careggi University Hospital, Stroke Unit||Recruiting|
|Florence, Italy, 50134|
|Principal Investigator:||Domenico Inzitari, MD||University of Florence|