Carotid Stenosis Management During the COVID-19 Era with Best Medical Intervention Alone (CASCOM Study)

Phase 4

• Conditions: Stroke prevention (ischaemic and haemorrhagic stroke); Arterial disease complication prevention; Carotid stenosis; Atherosclerosis; Carotid artery stenting; Carotid endarterectomy; Medical intervention; Non-stroke arterial disease complications; Stroke - Ischaemic; Stroke - Haemorrhagic

• Registration Number: ACTRN12621001604897
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-25
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 1543

Inclusion Criteria

i.Stroke or TIA patient with 50-99% carotid stenosis ipsilateral to the implicated brain region/eye or patient with 60-99% asymptomatic carotid stenosis (using 'NASCET' or 'NASCET' equivalent criteria to measure stenosis severity).
ii.Age at least 18 years.
iii.Willing and able to consent and be followed up for at least 24 months.
iv.Life expectancy at least 24 months (therefore, a 9-Point Clinical Frailty Scale Score of 1-6).
v.Absence of stroke resulting in severe deficit (mRS >3 and/or no useful function on either side of the body).
vi.Absence of neurological, psychological or cognitive condition likely to impede recognition of cerebral or retinal stroke or TIA, including moderate or severe dementia, neurodegenerative disease with significant neurological impairment present or expected in the next 3 years).
vii.Stenosis of study carotid artery attributable to atherosclerotic disease.
viii.No previous ipsilateral carotid endarterectomy, carotid angioplasty or stenting, trans-carotid arterial revascularisation or other carotid artery procedure.

Exclusion Criteria

None

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
First ipsilateral stroke (with respect to the study artery). <br><br>Stroke is defined as rapidly developed clinical symptoms and/or signs of cerebral or retinal dysfunction lasting >24 hours or leading to death, with no apparent cause other than focal neurovascular origin. Strokes will be classified as fatal if thought to be the primary or main cause of death or lead to a complication (such a pneumonia or pulmonary embolus) that causes death. <br><br>All strokes will be assessed based on the clinical information captured by the CASCOM Study investigator-clinician and adherence to the stroke definition given above. Strokes will be subdivided into type by the brain imaging results. The outcome measure of all strokes in the CASCOM Study will be validated by at least two CASCOM Study investigators who are not from the CASCOM Study site where the patient (CASCOM Study participant) with stroke was being followed-up.[Within 5 years of CASCOM Study recruitment]