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Severe atherosclerosis in the neck arteries (carotid stenosis) - an observational study

Sahlgrenska Carotid Cohort

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN12408874
Enrollment
1200
Registered
2024-05-07
Start date
2024-05-02
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Symptomatic carotid stenosis or carotid web Circulatory System

Interventions

The study assesses the risk of vascular events, radiology findings and blood biomarkers in patients treated at or referred to the neurology clinic at Sahlgrenska, Gothenburg, Sweden. Notable aspects

Sponsors

Region Västra Götaland
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1, 2 or 3 + 4 and 5: 1. Suspicion of symptomatic =50% carotid stenosis or occlusion 2. Symptomatic <50% stenosis (on all exams) that is considered for carotid surgery or stenting anyway, usually due to repeated symptoms despite best medical therapy 3. Carotid web, both symptomatic and asymptomatic 4. Treated at or referred to the neurology clinic at Sahlgrenska University Hospital 5. Informed consent

Exclusion criteria

Exclusion criteria: Does not meet the inclusion criteria

Design outcomes

Primary

MeasureTime frame
1. Recurrent preoperative stroke, assessed clinically, from presenting event until carotid surgery or stenting 2. Postoperative stroke or death, assessed clinically, within 30 days of carotid surgery or stenting 3. Long-term vascular events including, stroke, TIA, myocardial infarction, new-onset angina, new-onset heart failure, new-onset symptomatic peripheral artery disease, arterial revascularization and vascular death. Assessed for 10 years by annual review of medical records and diagnosis registry searches at 5 and 10 years.

Secondary

MeasureTime frame
1. Diagnostic: Flow measured in internal carotid artery and several comparison arteries on preoperative phase contrast MRI 2. Diagnostic: Artery diameters in the stenosis, internal and external carotid arteries measured on preoperative CT-angiography 3. Diagnostic: Flow velocities measured in common carotid artery, the stenosis and distal to the stenosis on preoperative ultrasound 4. Prognostic: All ipsilateral ischemic events (stroke, retinal artery occlusion, TIA and amaurosis fugax) recorded between the presenting event and surgery/stenting 5. Prognostic: All-type stroke recorded preoperatively between presenting event and surgery/stenting 6. Pathophysiological: Collateral status assessed by flow direction assessment of intracerebral arteries on preoperative phase contrast MRI 7. Pathophysiological: Collateral status assessed by appearance (normal/small/not seen) of intracerebral arteries on preoperative CT angiography 8. Pathophysiological: Velocity and flow profiles of the common carotid artery, the stenosis and distal to the stenosis on preoperative ultrasound 9. Pathophysiological: Intraoperative measurements of stump pressure, flow, cerebral oxygenation (NIRS)

Countries

Sweden

Contacts

Public ContactElias Johansson
elias.johansson@neuro.gu.se+46 (0)31 342 27 62

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026