The Immune Response to Stroke

• Sponsor: University of Oslo (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05277129
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Anticipated Duration (Months): 95.4
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

Some patients develop cognitive decline after a stroke, but we don't always understand the mechanisms. It has been proposed that a proportion of the patients develop an autoimmune immune response, and that this could potentially explain the cognitive decline in some of the patients. The current study aims to investigate this hypothesis in a subgroup of patients with stroke.

Condition or Disease	Intervention/Treatment	Phase
Stroke, Acute; Dementia	Other: Analysis of post-stroke immune responses

Study Design

• Study Type: Observational
• Anticipated Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Immune Response to Stroke
• Actual Study Start Date: Jun 24, 2021
• Anticipated Primary Completion Date: Dec 31, 2025
• Anticipated Study Completion Date: Jun 6, 2029

Arms and Interventions

Arm	Intervention/Treatment
Stroke patients	Other: Analysis of post-stroke immune responses; Analysis of immune responses in peripheral blood

Outcome Measures

Primary Outcome Measures

1. The B cell and T cell response in peripheral blood [1 day (subject inclusion)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Stroke < 72 h

• Age > 18 years

Exclusion Criteria:

• Brain hemorrhage verified by CT or MRI scan

• Previous or present immunological disease or other serious comorbidity

• Ongoing immune respons after infection or vaccination < 1 month

• Cognitive without ability to understand and/or give an informed consent to participate in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Akershus University Hospital	Lørenskog		Norway

Sponsors and Collaborators

• University of Oslo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Andreas Lossius, Associate Professor, University of Oslo
• ClinicalTrials.gov Identifier: NCT05277129
• Other Study ID Numbers: 2019/1252
• First Posted: Mar 14, 2022
• Last Update Posted: Mar 14, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stroke

Study Results

No Results Posted as of Mar 14, 2022