NCT05725694: STROKELABED

Acute Ischaemic STROKE: From LAboratory to the Patient's BED

Status unknown Last updated 15 March 2023

What this trial tests

trial in Acute Ischemic Stroke in 200 participants. Status unknown.

Timeline

1 October 2015

Primary endpoint
31 May 2020

31 March 2023

Quick facts

Lead sponsor	Istituto di Neuroscienze Consiglio Nazionale delle Ricerche
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	200
Start date	1 October 2015
Primary completion	31 May 2020
Estimated completion	31 March 2023

Conditions studied

• Acute Ischemic Stroke — all drugs for Acute Ischemic Stroke →
• Reperfusion Injury — all drugs for Reperfusion Injury →
• Cerebral Edema — all drugs for Cerebral Edema →
• Hemorrhagic Transformation Due to Acute Stroke — all drugs for Hemorrhagic Transformation Due to Acute Stroke →

Sponsor

Istituto di Neuroscienze Consiglio Nazionale delle Ricerche

Who can join

18 and older, any sex, with Acute Ischemic Stroke or Reperfusion Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Predicting reperfusion injury and functional status after stroke using blood biomarkers: the STROKELABED study.
   Vignoli A, Sticchi E, Piccardi B, Palumbo V, et al · · 2025 · cited 4× · PMID 40307929 · DOI 10.1186/s12967-025-06498-z
2. Acute ischemic STROKE - from laboratory to the Patient's BED (STROKELABED): A translational approach to reperfusion injury. Study Protocol.
   Sodero A, Conti E, Piccardi B, Sarti C, et al · · 2024 · cited 2× · PMID 39005711 · DOI 10.1515/tnsci-2022-0344