Managing carotid stenosis during the COVID-19 pandemic
Carotid Stenosis Management During COVID-19 Era - Best Medical Intervention Alone (CASCOM Pilot Study): A Prospective Observational Study
This study looks at how well treating patients with serious carotid artery narrowing with medication alone works during the COVID-19 pandemic, instead of using surgery, to see if it can help prevent strokes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | Zealand University Hospital Academic / other |
| Locations | 1 site (Roskilde) |
| Trial ID | NCT04947046 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the rate of ipsilateral stroke and other complications in patients with symptomatic carotid stenosis who are managed with best medical intervention alone, rather than undergoing invasive procedures like carotid endarterectomy (CEA) or carotid stenting (CAS). The study is particularly relevant during the COVID-19 pandemic, which has limited access to surgical interventions. By focusing on patients with advanced carotid stenosis, the researchers hope to gather data that could inform future treatment guidelines and justify the use of non-procedural management. The goal is to demonstrate a significant reduction in stroke rates compared to historical data from randomized trials.
Who should consider this trial
Good fit: Ideal candidates include patients aged over 80 with a life expectancy greater than 3 years who have symptomatic carotid stenosis but have not been offered timely surgical intervention.
Not a fit: Patients who are not symptomatic or those who have a life expectancy of less than 3 years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence supporting non-invasive management strategies for carotid stenosis, potentially improving patient outcomes during challenging times.
How similar studies have performed: While there is limited data on non-procedural management during the COVID-19 pandemic, previous studies have shown the effectiveness of best medical treatment in managing carotid stenosis, making this approach a novel exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who's life expectancy is \> 3 years despite age \> 80 years. * Patients who have not been timely offered CEA under COVID-19 (eg women / men with 50-69%), which can only be operated on after 4 weeks after their last symptom. * Patients with modified ranking scale (mRs) \> 3, which during rehabilitation improve and move to mRs \< 3. * High risk cardio pulmonary patients (ejection fraction \< 20% - severe chronic obstructive pulmonary disease) that is not estimated to withstand surgery or has a technically demanding neck anatomy with a life expectancy \> 3 years. * Patients who score below 15% on Carotid Artery Risk score (CAR-score) (5-year stroke risk is \< 15% with only best medical treatment) for ipsilateral stroke. * Patients with newly discovered cancer and stroke who require a cancer disease investigation or treatment and have a life expectancy of more than 3 years. * 50-69% and 70-99% narrowing (stenosis) of the ipsilateral internal carotid artery origin (and/or carotid bulb) verified by duplex ultrasound, CT-angio or MR-angio. * Presence of an ipsilateral non-disabling (non-severe) stroke (mRs \< 3, ie mRs of 1 or 2) or transient ischaemic attack (TIA) in the previous four (1,2) to six months (1,3) and ipsilateral 50-99% carotid stenosis measured using NASCET criteria. * Index symptoms attributable to atherosclerotic carotid disease (not due to fibromuscular dysplasia, aneurysm or tumour). * Absence of severe stroke on either side resulting in no useful function in the affected arterial territory * Absence of a known more severe ipsilateral intracranial infarct site of arterial narrowing * Absence of previous ipsilateral CEA or angioplasty/stenting or other carotid revascularisation procedure. * Mentally competent and consenting to participate in CASCOM Pilot Study in minimum 3 years. * Life expectancy \> 3 years including the absence of kidney, liver or lung failure or advanced cancer or advanced dementia, major/severe stroke (mRs \> 3), perceived significant frailty or unsuitable arterial anatomy. Risk classification level of IV or higher as well as CAR-score. * Absence of cardiac valvular or rhythm disorder likely associated with cardioembolism. In the absence of more specific published information the investigators will exclude patients with newly discovered atrial fibrillation and prosthetic heart valves from the primary analyses of symptomatic patients. Exclusion Criteria * Progressive neurological dysfunction and major Stoke mRs \> 3 without remission after 4 weeks from their last symptom. * Advanced cancer patients with survivals \< 3 years. * Newly Myocardia infarction within previous 6 months. * Stroke or TIA in connection with surgical procedure, heart surgery, neuro surgery or other major surgery. * Stroke and TIA due to Carotid dissection. * Stroke and TIA as urgently treated by EVT (endovascular trombendarterectomy) * Unstable angina, or myocardial infarction within previous 6 months, or progressive neurological dysfunction or major surgery within the previous 30 days.
Where this trial is running
Roskilde
- Zealand University Hospital — Roskilde, Denmark (Recruiting)
Study contacts
- Principal investigator: Emilie N Eilersen, MD — Zealand University Hospital, Denmark
- Study coordinator: Emilie N Eilersen, MD
- Email: emilie.eilersen@gmail.com
- Phone: +4523285378
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.