Carotid Stenosis Management During COVID-19 Era - Pilot Study

NCT04947046 | Recruiting

• 1 other identifier: P-2021-1
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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. In some places, the COVID-19 pandemic has made it difficult or impossible to perform CEA and CAS in time. This study aims to measure the rate of ipsilateral stroke and other complications in individuals with symptomatic carotid stenosis, whom for any reason are managed using current best medical intervention alone. The investigators expect at least 50% lowering of the ipsilateral stroke rate compared to that seen with medical intervention alone in past randomised trials.

Conditions

Carotid Stenosis; Carotid Artery Diseases; Carotid Atherosclerosis; Carotid Embolus; Stroke

Keywords

carotid stenosis; stroke prevention; carotid arterial disease complication

Outcome Measures

Primary Outcomes (1)

• Ipsilateral stroke, myocardial infarction, death

  Number of patients who gets recurrent ipsilateral stroke

  Within 2 years of CASCOM-pilot study recruitment

Secondary Outcomes (1)

• Any territory stroke, ipsilateral transient ischemic attack, any territory ischemic attack, myocardial infarction, limb aputation, death from any cause and death from arterial disease

  Within 2 years of study entry

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with advanced (50-99% or 60-99%, respectively) carotid stenosis in symptomatic patients who do not undergo CEA or CAS or similar procedures for any reason, including lack of resources caused by the coronavirus pandemic, situations of unproven procedural benefit, anticipated procedural futility or net harm or patient refusal. Hence, the investigators will study patients for whom carotid procedures are not possible or considered unethical.

You may qualify if:

• 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.
• % 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Zealand University Hospital

Roskilde, 4000, Denmark

RECRUITING

Related Publications (6)

• Barnett HJ, Taylor DW, Eliasziw M, Fox AJ, Ferguson GG, Haynes RB, Rankin RN, Clagett GP, Hachinski VC, Sackett DL, Thorpe KE, Meldrum HE, Spence JD. Benefit of carotid endarterectomy in patients with symptomatic moderate or severe stenosis. North American Symptomatic Carotid Endarterectomy Trial Collaborators. N Engl J Med. 1998 Nov 12;339(20):1415-25. doi: 10.1056/NEJM199811123392002.

  PMID: 9811916 BACKGROUND

• Randomised trial of endarterectomy for recently symptomatic carotid stenosis: final results of the MRC European Carotid Surgery Trial (ECST). Lancet. 1998 May 9;351(9113):1379-87.

  PMID: 9593407 BACKGROUND

• MRC European Carotid Surgery Trial: interim results for symptomatic patients with severe (70-99%) or with mild (0-29%) carotid stenosis. European Carotid Surgery Trialists' Collaborative Group. Lancet. 1991 May 25;337(8752):1235-43.

  PMID: 1674060 BACKGROUND

• Abbott AL, Brunser AM, Giannoukas A, Harbaugh RE, Kleinig T, Lattanzi S, Poppert H, Rundek T, Shahidi S, Silvestrini M, Topakian R. Misconceptions regarding the adequacy of best medical intervention alone for asymptomatic carotid stenosis. J Vasc Surg. 2020 Jan;71(1):257-269. doi: 10.1016/j.jvs.2019.04.490. Epub 2019 Sep 26.

  PMID: 31564585 BACKGROUND

• Abbott A. Critical Issues That Need to Be Addressed to Improve Outcomes for Patients With Carotid Stenosis. Angiology. 2016 May;67(5):420-6. doi: 10.1177/0003319716631266. Epub 2016 Feb 27.

  PMID: 26922085 BACKGROUND

• Shahidi S, Owen-Falkenberg A, Gottschalksen B, Ellemann K. Risk of early recurrent stroke in symptomatic carotid stenosis after best medical therapy and before endarterectomy. Int J Stroke. 2016 Jan;11(1):41-51. doi: 10.1177/1747493015609777.

  PMID: 26763019 BACKGROUND

MeSH Terms

Conditions

Carotid Stenosis; Carotid Artery Diseases; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Emilie N Eilersen, MD

  Zealand University Hospital, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilie N Eilersen, MD

CONTACT

+4523285378; emilie.eilersen@gmail.com

Saeid H Shahidi, MD

CONTACT

shsh@regionsjaelland.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 1, 2021
• Study Start: March 11, 2020
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2026
• Last Updated: December 1, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)