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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05725694
Other study ID # 24055
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date October 1, 2015
Est. completion date March 31, 2023

Study information

Verified date March 2023
Source Istituto di Neuroscienze Consiglio Nazionale delle Ricerche
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Background: Recanalization strategies have radically changed the outcome in a significant part of stroke patients. The unpredictable occurrence of cerebral edema (CE) and hemorrhagic transformation (HT) are frequent events in patients affected by ischemic stroke, even when an effective vessel recanalization has been achieved. These complications, related with blood brain barrier (BBB) disruption, remain difficult to prevent or treat, and antagonize the beneficial effect of successful recanalization, leading to poor outcome. Aim: to shed light on the reperfusion injury biological bases, this study aims at evaluating the effects of circulating and imaging biomarkers in relation to CE and HT both in stroke patients and in a coherent murine stroke model. A close interaction between clinical and preclinical research could lead to a broader understanding of the results deriving from the individual lines of activity, allowing a deeper interpretation of the underlying phenomena. Methods: The clinical setting is a retrospective observational study enrolling consecutive patients with acute ischemic stroke in the anterior circulation territory, treated with reperfusion therapies, at Careggi University Hospital in Florence (Italy) from October 1, 2015 to May 31, 2020. In this cohort, the investigators will apply a new approach to assess the presence of CE and HT after stroke in CT scans, through the quantification of anatomical distortion (AD) (induced by fluid extravasation in brain tissue) at 24 hours. A large panel of blood biomarkers related to inflammation, endothelial dysfunction , and fibrin resistance to lysis, will be measured as blood samples are taken from each patient before and 24 hours after thrombolysis or thrombectomy. The role of both AD and blood biomarkers as predictors of 3 months functional outcome, assessed by modified Rankin Scale (mRS), will be estimated. Using a translational approach the investigators will develop a new mouse model of light-induced occlusion/reperfusion of the middle cerebral artery (MCA) to better reproduce the human setting. Then, the investigators will assess functional impairment induced by stroke with and without recanalization at different time points and the investigators will assess through ex vivo experiments the insurgence of BBB alterations 24 hours after the lesion. Finally, the investigators will characterize the stroke volume and the inflammation one week after stroke.


Description:

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Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Istituto di Neuroscienze Consiglio Nazionale delle Ricerche Careggi Hospital, University of Florence

References & Publications (7)

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Outcome

Type Measure Description Time frame Safety issue
Primary 3 month clinical-functional outcome All stroke patients are followed-up 3 months after the ictal event in the out-patient clinic of Careggi University Hospital, and their functional outcome is assessed according to the modified Rankin Scale. The Modified Rankin Scale is a 6 point disability scale with possible scores ranging from 0 (no symptoms) to 5 (severe disability). A separate category of 6 is used for patients who expire. For each patient enrolled in the study the functional outcome is assessed 3 months after the ictal event
Primary The occurrence of Cerebral Edema Defined according to Cerebral Edema Classification used by the Helsinki Stroke Thrombolysis Registry Group (Strbian et al. 2013) on 24h Non-enhanced CT brain scan. [CED1= Focal brain swelling up to one-third of the hemisphere; CED2= Focal brain swelling greater than one-third of the hemisphere; CED3= Brain swelling with midline shift] Non-enhanced CT brain scans acquired at 24 hours after the ictal event
Primary The occurrence of Haemorrhagic Transformation Defined according to the ECASS (European Cooperative Acute Stroke Study) II radiographic classification of hemorrhagic transformation after ischemic stroke (Larrue et al. 2001) on 24h Non-enhanced CT brain scan. [HI1: Hemorrhagic infarction type 1; HI2: Hemorrhagic infarction type 2; PH1: Parenchymal hematoma type 1; PH2: Parenchymal hematoma type 2.] Non-enhanced CT brain scans acquired at 24 hours after ictal event
Primary The occurrence of relevant Haemorrhagic Transformation The presence and grading of Haemorrhagic Transformation defined as haemorrhagic infarction type two or any type of parenchymal haemorrhage (PH1 and PH2) according to ECASS II classification (Larrue et al, 2001) on 24h Non-enhanced CT brain scan. [PH1: Parenchymal hematoma type 1; PH2: Parenchymal hematoma type 2.] Non-enhanced CT brain scans acquired at 24 hours after ictal event
Secondary Anatomical Distortion (AD) volume (ml) A novel approach to evaluate brain swelling induced by cerebral edema and haemorrhagic transformation after ischemic stroke on Non-enhanced CT scans, through the quantification of the Anatomical Distortion obtained by the comparison of Non-enhanced CT scans acquired at 24 hours and at admission, according to the method described by Harston et al. in 2018. Non-enhanced CT brain scans acquired at 2 timepoints: 1) Baseline = before rtPA administration or thrombectomy, 2) Follow-up at 24 hours
Secondary Corrected infarct volume (ml) Corrected infarct volume will be obtained by subtracting Anatomical Distortion from the total (or uncorrected) lesion. [Corrected infarct volume= total lesion volume - AD] Non-enhanced CT brain scans acquired at 2 time points: 1) Baseline = before rtPA administration or thrombectomy, 2) Follow-up at 24 hours
Secondary Relative Anatomical Distortion (AD) volume (ml) To adjust for ischemic lesion dimensions, the Relative AD volume will be obtained by dividing AD by the corrected infarct volume. [Relative AD = AD/corrected infarct volume]. Non-enhanced CT brain scans acquired at 2 time points: 1) Baseline = before rtPA administration or thrombectomy, 2) Follow-up at 24 hours
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