Reperfusion Injury After Stroke Study

NCT03041753 | Unknown DMC

• 1 other identifier: RF-2011-02348240
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke

Keywords

stroke; thrombolysis; metalloproteinases; blood brain barrier

Outcome Measures

Primary Outcomes (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

  Relevant Hemorrhagic Transformation OR Relevant Cerebral Edema

  24 hours from symptom onset

Secondary Outcomes (2)

• Categorical shift in mRS score at 3 months

  3 months from symptom onset

• Symptomatic hemorrhagic transformation

  24 hours from symptom onset

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• Controindications for iodine contrast medium

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Careggi: lead
• Ministry of Health, Italy: collaborator

Study Sites (1)

Careggi University Hospital, Stroke Unit

Florence, Italy, 50134, Italy

RECRUITING

Related Publications (1)

• Piccardi B, Arba F, Nesi M, Palumbo V, Nencini P, Giusti B, Sereni A, Gadda D, Moretti M, Fainardi E, Mangiafico S, Pracucci G, Nannoni S, Galmozzi F, Fanelli A, Pezzati P, Vanni S, Grifoni S, Sarti C, Lamassa M, Poggesi A, Pescini F, Pantoni L, Gori AM, Inzitari D. Reperfusion Injury after ischemic Stroke Study (RISKS): single-centre (Florence, Italy), prospective observational protocol study. BMJ Open. 2018 May 24;8(5):e021183. doi: 10.1136/bmjopen-2017-021183.

  PMID: 29794101 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood; thrombus eventually taken during endovascular procedure

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Domenico Inzitari, MD

  University of Florence

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Domenico Inzitari, MD

CONTACT

0557947447; domenico.inzitari@unifi.it

Benedetta Piccardi, MD

CONTACT

bpiccardi@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 23, 2016
• First Posted: February 3, 2017
• Study Start: September 1, 2015
• Primary Completion: August 1, 2018
• Study Completion: November 1, 2018
• Last Updated: February 3, 2017

Record last verified: 2017-02

Locations

IT (1)