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Thrombo-inflammation in Acute Neurovascular Diseases: Definition of New Therapeutic Targets (TARGETS)

Observational Delayed Cerebral Ischemia After Subarachnoid Hemorrhage Ischemic Stroke of Large or Medium Vessels

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Delayed Cerebral Ischemia After Subarachnoid Hemorrhage, Ischemic Stroke of Large or Medium Vessels. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Thrombo-inflammation Des Maladies Neurovascualires aiguës : définition de Nouvelles Cibles thérapeutiques (TARGETS)

Overview

The objective of this observational study is to compare the relative concentrations of various thrombo-inflammatory markers at different follow-up time points in: * patients with or without delayed cerebral ischemia after subarachnoid hemorrhage, and * patients with or without rapid progression of necrotic volume after an ischemic stroke due to large- or medium-vessel occlusion in the anterior circulation. The main question this study aims to answer is: How do thrombo-inflammatory marker concentrations evolve over time and differ between patients? Researchers will compare patients with or without delayed cerebral ischemia after subarachnoid hemorrhage, as well as patients with or without rapid progression of necrotic volume following an ischemic stroke due to large- or medium-vessel occlusion in the anterior circulation, to determine whether there are differences in thrombo-inflammatory marker concentrations and in their evolution over time. Participants will undergo blood sampling at five different time points. In addition, participants will complete a Montreal Cognitive Assessment (MoCA) questionnaire during the 3-month follow-up visit.

Primary outcome measures

  • Investigation of changes in thrombo-inflammatory marker concentrations between patients and over time. [Time frame: From enrollment to Month 3 visit]

Eligibility criteria

Inclusion criteria

  • Patients aged 18 years or older
  • Admitted within 8 hours of an acute ischemic stroke (AIS) due to large-vessel occlusion (LVO) or medium-vessel occlusion (MeVO) of the anterior circulation, with a NIHSS (National Institutes of Health Stroke Scale) score > 5 (M1, M2, M3, A1, A2, A3, P1, P2)
  • Or admitted within 36 hours of acute symptoms related to aneurysmal subarachnoid hemorrhage (SAH)

Exclusion criteria

  • Patients with pre-existing functional and/or cognitive disability (modified Rankin Scale, mRS > 1)
  • Patients under legal protection or guardianship
  • Patients with secondary hemorrhagic transformation of an acute ischemic stroke

Patients with acute ischemic stroke and NIHSS > 5 without LVO or MeVO of the anterior circulation on imaging will be secondarily excluded. Perfusion imaging will not be performed as part of the research protocol. Excluded patients will be replaced.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Ray B, Ross SR, Danala G, Aghaei F, Nouh CD, Ford L, Hollabaugh KM, Karfonta BN, Santucci JA, Cornwell BO, Bohnstedt BN, Zheng B, Dale GL, Prodan CI. Systemic response of coated-platelet and peripheral blood inflammatory cell indices after aneurysmal subarachnoid hemorrhage and long-term clinical outcome. J Crit Care. 2019 Aug;52:1-9. doi: 10.1016/j.jcrc.2019.03.003. Epub 2019 Mar 14. PMID 30904732
  • Tso MK, Macdonald RL. Acute microvascular changes after subarachnoid hemorrhage and transient global cerebral ischemia. Stroke Res Treat. 2013;2013:425281. doi: 10.1155/2013/425281. Epub 2013 Mar 25. PMID 23589781
  • Friedrich V, Flores R, Muller A, Sehba FA. Luminal platelet aggregates in functional deficits in parenchymal vessels after subarachnoid hemorrhage. Brain Res. 2010 Oct 1;1354:179-87. doi: 10.1016/j.brainres.2010.07.040. Epub 2010 Jul 21. PMID 20654597
  • Dankbaar JW, Rijsdijk M, van der Schaaf IC, Velthuis BK, Wermer MJ, Rinkel GJ. Relationship between vasospasm, cerebral perfusion, and delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage. Neuroradiology. 2009 Dec;51(12):813-9. doi: 10.1007/s00234-009-0575-y. Epub 2009 Jul 22. PMID 19623472
  • Park SW, Lee JY, Heo NH, Han JJ, Lee EC, Hong DY, Lee DH, Lee MR, Oh JS. Short- and long-term mortality of subarachnoid hemorrhage according to hospital volume and severity using a nationwide multicenter registry study. Front Neurol. 2022 Aug 5;13:952794. doi: 10.3389/fneur.2022.952794. eCollection 2022. PMID 35989903
  • Fan J, Li X, Yu X, Liu Z, Jiang Y, Fang Y, Zong M, Suo C, Man Q, Xiong L. Global Burden, Risk Factor Analysis, and Prediction Study of Ischemic Stroke, 1990-2030. Neurology. 2023 Jul 11;101(2):e137-e150. doi: 10.1212/WNL.0000000000207387. Epub 2023 May 17. PMID 37197995
  • Naraoka M, Matsuda N, Shimamura N, Ohkuma H. Role of microcirculatory impairment in delayed cerebral ischemia and outcome after aneurysmal subarachnoid hemorrhage. J Cereb Blood Flow Metab. 2022 Jan;42(1):186-196. doi: 10.1177/0271678X211045446. Epub 2021 Sep 9. PMID 34496662
  • Frontera JA, Provencio JJ, Sehba FA, McIntyre TM, Nowacki AS, Gordon E, Weimer JM, Aledort L. The Role of Platelet Activation and Inflammation in Early Brain Injury Following Subarachnoid Hemorrhage. Neurocrit Care. 2017 Feb;26(1):48-57. doi: 10.1007/s12028-016-0292-4. PMID 27430874

Identifiers

NCT: NCT07354321 · B7072025000062

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗