Atherosclerosis and Acute Ischemic Stroke Study

NCT ID: NCT03685006

Last Updated: 2022-04-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-01-01
• Study Completion Date: 2030-01-01

Brief Summary

A significant proportion of strokes are thromboembolic in nature, arising from atherosclerotic plaque at the carotid bifurcation. It is now wellknown that inflammation plays a key role in atherogenesis and plaque destabilization. However the identification and characterization of the different inflammatory factors, as well as their relative importance, have not been clarified. This main aim of this study is to identify new risk markers for atherosclerosis and to characterize more precise methods for detection of the unstable carotid plaque with increased stroke-risk.

Detailed Description

This project include patients with asymptomatic and symptomatic carotid stenosis >50%. Patients with acute ischemic stroke will also be included with carotid artery stenosis <50% (study 3). The patient group will undergo a clinical neurological examination, ultrasound of the neck-arteries and a blood sample. The majority will also have a CT-angiography of the neck arteries and a cerebral MRI or CT. Carotid plaques removed by surgery (carotid end-arterectomy) and thrombs removed by thrombectomy will undergo histological analyses.

Study 1:

Plasma markers will be analysed and compared to clinical symptoms, ultrasound assessment of the plaque, cerebral MRI (or CT).

Study 2:

Results from advanced ultrasound of the carotid plaque including assessment of plaque morphology will be compared to histology of the removed plaque. Plasma markers and clinic will be related to the findings. The correlation between the different diagnostic modalities and the histologic conclusion will be assessed.

Study 3:

This study focus on plasma markers in an acute ischemic stroke due to a carotid plaque compared to an acute ischemic stroke with a cardial embolic source. Thrombi removed from the cerebral artery by thrombectomy will undergo histological analysis and the results will be compared to plasma markers and stroke aetiology.

Conditions

Atherosclerosis; Inflammation; Ischemic Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• All patients with an atherosclerotic carotid stenosis >50% admitting one of the study centres as an in-patient or an out-patient will be considered for inclusion.
• Acute stroke patients treated with thrombectomy at Oslo University Hospital will be included even though the carotid stenosis is < 50%.

Exclusion Criteria

• Malign disease
• Inflammatory disease

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oslo

OTHER

Sponsor Role: collaborator

University Hospital, Akershus

OTHER

Sponsor Role: collaborator

Ostfold Hospital Trust

OTHER

Sponsor Role: collaborator

Vestre Viken Hospital Trust

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mona Skjelland

Consultant, Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mona Skjelland, MD/postdoc

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital, Oslo, Norway

Locations

Oslo University Hospital

Oslo, , Norway

Countries

Norway

Other Identifiers

REK 2009/5237

Identifier Type: -

Identifier Source: org_study_id