- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07354321
Thrombo-inflammation in Acute Neurovascular Diseases: Definition of New Therapeutic Targets (TARGETS)
Thrombo-inflammation Des Maladies Neurovascualires aiguës : définition de Nouvelles Cibles thérapeutiques (TARGETS)
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.
Study Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: François Delvoye, MD, PhD
- Phone Number: 04/3236630
- Email: fdelvoye@chuliege.be
Study Contact Backup
- Name: Simon Detriche, PhD
- Phone Number: 043236684
- Email: sdetriche@chuliege.be
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
AIC
Patient with rapid progression of necrotic volume after an ischemic stroke due to large- or medium-vessel occlusion in the anterior circulation
|
|
HSA
Patient with delayed cerebral ischemia after subarachnoid hemorrhage
|
|
healthy volunteer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Investigation of changes in thrombo-inflammatory marker concentrations between patients and over time.
Time Frame: From enrollment to Month 3 visit
|
Investigation of changes in thrombo-inflammatory marker concentrations between patients and over time.
|
From enrollment to Month 3 visit
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Gatti JL, Dacheux JL. Immunological cross-reaction between sperm dynein heavy chains from different species. Reprod Nutr Dev. 1996;36(2):213-20. doi: 10.1051/rnd:19960206.
- Lewis DF. Quantitative structure-activity relationships in a series of alcohols exhibiting inhibition of cytochrome P-450-mediated aniline hydroxylation. Chem Biol Interact. 1987;62(3):271-80. doi: 10.1016/0009-2797(87)90027-5.
- Rector TS, Carlyle PF, Cohn JN. Reduced atrial natriuretic factor after ligation of the left coronary artery in rats. Am Heart J. 1985 Dec;110(6):1197-9. doi: 10.1016/0002-8703(85)90012-2.
- Knaff DB. Structure and regulation of ribulose-1,5-bisphosphate carboxylase/oxygenase. Trends Biochem Sci. 1989 May;14(5):159-60. doi: 10.1016/0968-0004(89)90264-8. No abstract available.
- Liu X, Wang CA, Chen YZ. [Bovine serum albumin-conjugated corticosterone inhibits the release of arginine vasopressin]. Sheng Li Xue Bao. 1996 Apr;48(2):173-8. Chinese.
- Hayes JC. Practice improvement project measures radiology quality. Diagn Imaging (San Franc). 1999 Feb;21(2):22. No abstract available.
- Fujisawa T, Ikegami H, Yamato E, Takekawa K, Nakagawa Y, Hamada Y, Oga T, Ueda H, Shintani M, Fukuda M, Ogihara T. Association of Trp64Arg mutation of the beta3-adrenergic-receptor with NIDDM and body weight gain. Diabetologia. 1996 Mar;39(3):349-52. doi: 10.1007/BF00418352.
- Angra SK, Mohan M, Saini JS. Medical therapy of cataract (evaluation of Catalin). Indian J Ophthalmol. 1983 Jan;31(1):5-8. No abstract available.
- Boll IT, Domeyer C. Lymphocytes as inducers of mitoses of human morphologically identifiable progenitor cells. Phase contrast observations. Exp Hematol. 1982 Apr;10(4):326-31.
- Coulibaly AP, Pezuk P, Varghese P, Gartman W, Triebwasser D, Kulas JA, Liu L, Syed M, Tvrdik P, Ferris H, Provencio JJ. Neutrophil Enzyme Myeloperoxidase Modulates Neuronal Response in a Model of Subarachnoid Hemorrhage by Venous Injury. Stroke. 2021 Oct;52(10):3374-3384. doi: 10.1161/STROKEAHA.120.033513. Epub 2021 Aug 18.
- Ishikawa M, Kajimura M, Morikawa T, Tsukada K, Tsuji T, Kusaka G, Tanaka Y, Suematsu M. Leukocyte plugging and cortical capillary flow after subarachnoid hemorrhage. Acta Neurochir (Wien). 2016 Jun;158(6):1057-67. doi: 10.1007/s00701-016-2792-6. Epub 2016 Apr 4.
- Ishikawa M, Kusaka G, Yamaguchi N, Sekizuka E, Nakadate H, Minamitani H, Shinoda S, Watanabe E. Platelet and leukocyte adhesion in the microvasculature at the cerebral surface immediately after subarachnoid hemorrhage. Neurosurgery. 2009 Mar;64(3):546-53; discussion 553-4. doi: 10.1227/01.NEU.0000337579.05110.F4.
- Sehba FA, Mostafa G, Friedrich V Jr, Bederson JB. Acute microvascular platelet aggregation after subarachnoid hemorrhage. J Neurosurg. 2005 Jun;102(6):1094-100. doi: 10.3171/jns.2005.102.6.1094.
- Chen Y, Galea I, Macdonald RL, Wong GKC, Zhang JH. Rethinking the initial changes in subarachnoid haemorrhage: Focusing on real-time metabolism during early brain injury. EBioMedicine. 2022 Sep;83:104223. doi: 10.1016/j.ebiom.2022.104223. Epub 2022 Aug 13.
- Hoh BL, Ko NU, Amin-Hanjani S, Chou SH-Y, Cruz-Flores S, Dangayach NS, Derdeyn CP, Du R, Hanggi D, Hetts SW, Ifejika NL, Johnson R, Keigher KM, Leslie-Mazwi TM, Lucke-Wold B, Rabinstein AA, Robicsek SA, Stapleton CJ, Suarez JI, Tjoumakaris SI, Welch BG. 2023 Guideline for the Management of Patients With Aneurysmal Subarachnoid Hemorrhage: A Guideline From the American Heart Association/American Stroke Association. Stroke. 2023 Jul;54(7):e314-e370. doi: 10.1161/STR.0000000000000436. Epub 2023 May 22.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B7072025000062
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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