Neuroimaging in Acute Stroke

NCT05864495 | Unknown

• 1 other identifier: STRO_2023/05
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The main aim of this study is to identify the predictive value of CT parameters (e-ASPECTS, CTP, collateral vessel status, volume, and location of ischemic lesion volume) at a 3-month functional outcome defined by the modified Rankin scale (mRS) in patients with non-lacunar stroke after recanalization treatment (Intravenous Thrombolytic Therapy and/or Mechanical Thrombectomy, or conservative treatment).

Conditions

Stroke, Acute; Stroke, Ischemic

Keywords

stroke; neuroimaging; e-ASPECTS; Brainomix

Outcome Measures

Primary Outcomes (1)

• Modified Rankin Scale

  To find the predictive value of CT parameters (e-ASPECTS, CTP (CTP provides absolute and relative information about brain perfusion parameters, namely cerebral blood flow (CBF), cerebral blood volume (CBV), mean transit time (MTT), and time to peak (TTP). MTT is the time between the arterial inflow and the venous outflow), collateral vessel status, volume and location of ischemic lesion volume) at a 3 month functional outcome defined by the modified Rankin scale (mRS) in patients with non-lacunar stroke after recanalization treatment (IVT and/or MT, or conservative therapy)

  3 months

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

Consecutively admitted patients with ischemic stroke over the age of 18.

You may qualify if:

• Acute ischemic stroke within 12 hours of onset, treated with intravenous thrombolysis and/or mechanical thrombectomy or conservatively.
• Unknown time of onset of ischemic stroke.
• Wake-up stroke (with symptoms of stroke since awakening).

You may not qualify if:

• Pre-event modified Rankin Scale (mRS) score \> 4 points.
• Acute haemorrhagia or other NCCT finding excluding dg. ischemic stroke.

Sponsors & Collaborators

• University Hospital Ostrava: lead
• St. Anne's University Hospital Brno, Czech Republic: collaborator
• Na Homolce Hospital: collaborator
• General University Hospital, Prague: collaborator
• Pardubice Hospital: collaborator
• University Hospital Hradec Kralove: collaborator
• University Hospital, Motol: collaborator
• University Hospital Kralovske Vinohrady: collaborator
• Hospital Pisek: collaborator
• Vitkovice Hospital: collaborator
• České Budějovice Hospital: collaborator
• Jihlava Hospital: collaborator
• Brno University Hospital: collaborator
• Karvina Miners Hospital: collaborator
• Regional Hospital Liberec: collaborator
• Vyskov Hospital: collaborator
• Thomayer University Hospital: collaborator
• Municipal Hospital Ostrava: collaborator
• Regional Hospital Mlada Boleslav: collaborator
• Regional Hospital Pribram: collaborator

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

RECRUITING

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Michal Bar, Assoc.Prof.,MD,Ph.D.

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiří Hynčica

CONTACT

0042059737; jiri.hyncica@fno.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 18, 2023
• Study Start: May 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: May 1, 2025
• Last Updated: July 17, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)