Not Yet RecruitingPhase 4ACTRN12621001604897

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

Carotid Stenosis Management During the COVID-19 Era with Best Medical Intervention Alone (CASCOM Study): A prospective study of the rate of ipsilateral stroke in five risk-stratified cohorts of patients with at least 50% carotid artery stenosis

Sponsor

Monash University

Enrollment

1,543 participants

Start Date

Jul 1, 2022

Study Type

Interventional

Conditions

Arterial disease complication prevention Carotid artery stenting Medical intervention Stroke prevention (ischaemic and haemorrhagic stroke)Atherosclerosis Non-stroke arterial disease complications

Summary

Background Carotid endarterectomy (CEA) and carotid stenting (CAS) are often performed for subgroups of patients for whom procedural benefit has not been established in randomised trials and despite evidence of serious procedural risk. Furthermore, there is no current evidence of procedural benefit compared to optimal medical intervention alone (lifestyle coaching and medication) for any individuals. In some places, the COVID-19 pandemic has made it difficult or impossible to perform CEA and CAS. Aim/Objectives 1. To measure the rate of ipsilateral (same-sided) stroke, and other arterial disease complications, in patients with advanced (50-99%) carotid stenosis who, for any reason, are managed using current best medical intervention alone. Reasons for a nonprocedural approach may include insufficient resources caused by the coronavirus pandemic, unproven procedural benefit, anticipated procedural futility and/or net harm, or patient refusal. We will study patients for whom carotid procedures are not possible or considered unethical and, therefore, where a randomised trial approach involving carotid procedures is inappropriate. 2. To compare the CASCOM Study rate of ipsilateral stroke for symptomatic patients with that reported in the North American Symptomatic Carotid Endarterectomy Trial (NASCET) and the European Carotid Surgery Trial (ECST), and the CASCOM Study rate of ipsilateral stroke associated with asymptomatic carotid stenosis with that reported in the Asymptomatic Carotid Atherosclerosis Study (ACAS). Methods CASCOM is a prospective cohort study of current best medical intervention alone for stroke prevention in people who become patients by way of their referral for carotid imaging by a medical practitioner. It is also a multi-national, multi-specialty, collaborative, quality assurance and evaluation project. We will separate patients into those who would, and would not, have been eligible for past randomised CEA trials. We plan to study >367 symptomatic patients and >576 asymptomatic patients in the former, ‘eligible’, category and use them for hypothesis testing. We expect at least a 50% lowering of stroke rates with medical intervention alone in the CASCOM Study compared to that seen in past randomised trials. In addition, we plan to study 600 patients in the latter randomised trial ‘ineligible’ category and report their ipsilateral stroke rate over 5 years of follow-up. We will use ‘REDCap’ (Research Electronic Data Capture) for case reporting. Findings and Significance In CASCOM we expect at least 50% lowering of the ipsilateral stroke rate compared to that seen with medical intervention alone in past randomised trials. If correct, CASCOM will provide new evidence that past randomised trials of CEA and CAS are outdated and elucidate new, improved standards for preventing stroke and other arterial disease complications.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria8

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 Criteria1

None

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

The CASCOM Study intervention is current best practice medical intervention (lifestyle coaching and medication) for the prevention of stroke and other arterial disease complications. The primary aim of the CASCOM Study is to measure the rate of ipsilateral stroke, and other arterial disease complications, in individuals with advanced (50-99%) carotid stenosis who, for any reason, are managed using current best practice medical intervention alone. 5 patient cohorts will be studied: 1. Symptomatic patients with 50-99% (NASCET method) ipsilateral carotid Stenosis who would have been eligible for NASCET/ECST. These patients will be eligible for CASCOM Study primary analyses and hypothesis testing. (n= 367) 2. Patients with 60-99% (NASCET method) asymptomatic carotid stenosis who would have been eligible for ACAS. These patients will be eligible for CASCOM Study primary analyses and hypothesis testing. (n= 576) 3. Patients symptomatic within the last 6 months with 50-99% (NASCET method) ipsilateral carotid stenosis and would NOT have been eligible for NASCET/ECST. These patients will be eligible for CASCOM Study secondary analyses (outcome measure event rate measurements). (n= 200) 4. Patients symptomatic more than 6 months ago with 50-99% (NASCET method) ipsilateral carotid stenosis and would NOT have been eligible for NASCET/ECST. These patients will be Eligible for CASCOM Study Secondary Analyses (outcome measure event rate measurements). (n= 200) 5. Patients with 60-99% (NASCET method) asymptomatic carotid stenosis who would NOT have been eligible for ACAS. These patients will be eligible for CASCOM Study Secondary Analyses (outcome measure event rate measurements). (n= 200) The medical intervention received by the study participants will be tailored to their arterial disease risk factor profile and based on our multinational expert review regarding how to best diagnose and ameliorate the leading arterial disease risk factors, including hypertension, hyperlipidaemia, atrial fibrillation, tobacco smoking, physical inactivity, excessive weight, hormonal status and diabetes. This review is comprehensive and incorporates key recommendations from guidelines. The CASCOM Study expert review and summary of current best medical intervention for individuals with carotid stenosis will be published and distributed to all CASCOM Study investigators and participants. It will be used to guide and prompt clinicians and patients. It will be updated as advances are made. CASCOM Study investigators and participants will be informed in writing of advances as soon as possible. Current best medical intervention will be delivered by CASCOM Study investigators to CASCOM Study participants during routine clinical assessments. Preference will be given to face-to-face assessments. However, telehealth assessments will be permissible if this is the best option at the time. Patient assessments will be performed at baseline, 1 month, 3 months and then every six months for as long as the study is running- which is a minimum of five years. Duration of consultations will reflect the individual patient need and stage of study follow-up. Medications, route of administration and dosage and lifestyle interventions (such as advice in diet exercise and smoking cessation) will depend on an individual patient's risk factor profile and current best evidence as summarised in our multi-expert review on the subject. Patient adherence to taking medication as prescribed will be assessed using a simple two question multi-choice questionnaire at each CASCOM Study assessment.