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Reperfusion Injury After Stroke Study (RISKS)

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.
 
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
Sponsor:
Collaborator:
Ministry of Health, Italy
Information provided by (Responsible Party):
Domenico Inzitari, University of Florence

Brief 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.


Condition or disease
Ischemic Stroke

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Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort
Intervention group
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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Categorical shift in mRS score at 3 months [ Time Frame: 3 months from symptom onset ]
  2. 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
Blood; thrombus eventually taken during endovascular procedure


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This is an observational hospital-based study that will include 140 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
Criteria

Inclusion Criteria:

  • Ischemic stroke patients in the anterior circulation territory
  • NIHSS ≥7
  • within 12 hours from last seen well

Exclusion Criteria:

Controindications for iodine contrast medium


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): NCT03041753


Contacts
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Contact: Domenico Inzitari, MD 0557947447 domenico.inzitari@unifi.it
Contact: Benedetta Piccardi, MD bpiccardi@hotmail.com

Locations
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Italy
Careggi University Hospital, Stroke Unit Recruiting
Florence, Italy, 50134
Sponsors and Collaborators
Azienda Ospedaliero-Universitaria Careggi
Ministry of Health, Italy
Investigators
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Principal Investigator: Domenico Inzitari, MD University of Florence
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Domenico Inzitari, Professor, University of Florence
ClinicalTrials.gov Identifier: NCT03041753    
Other Study ID Numbers: RF-2011-02348240
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Domenico Inzitari, University of Florence:
stroke
thrombolysis
metalloproteinases
blood brain barrier
Additional relevant MeSH terms:
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Stroke
Reperfusion Injury
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Pathologic Processes