Carotid Artery Disease After Stroke (CADAS).

NCT03721523 | Withdrawn

• 1 other identifier: UHSMCADAS
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief Summary

Stroke is a significant medical problem with 150,000 events occurring per year in the UK and incurring healthcare costs of £4 billion per year. Fifty percent of strokes will leave a lasting disability on first manifestation and 10-15% (roughly 16,500 per year) are unheralded ischaemic events in previously asymptomatic Carotid artery disease. Carotid Artery Disease is caused by the formation of an atherosclerotic plaque in the vessel. Stroke or TIA occurs when plaque or adherent thrombus breaks off and embolises to the brain, blocking off its blood supply. Hence, a carotid plaque is said to be symptomatic if it has caused a Stroke or TIA in the territory of the brain supplied by that vessel in the previous six months. Currently, the degree of stenosis (narrowing) of the artery by doppler ultrasound is the main assessment performed. Doppler ultrasound measures stenosis and elevation of blood flow velocity in the artery prior to surgical intervention. However, it has been shown that the degree of stenosis is a poor predictor of stroke as many asymptomatic patients have severe stenosis and many symptomatic patients have moderate stenosis. Stenosis is a two dimensional assessment of a 3-D structure. Other features of the plaque should be considered including the volume of the carotid plaque and its constituents. Carotid Plaque Volume has been measured in 339 individuals, with plaque volume being higher in symptomatic than asymptomatic individuals. In this study, plaque volume did not correlate with stenosis degree. No studies have been conducted measuring the change in carotid plaque volume and morphology following a stroke. This pilot study will perform serial duplex scans on recently symptomatic individuals over a 12 week period and observe the changes in Plaque Volume and morphology. This will attempt to prove that carotid plaque volume is a better predictor of stroke than stenosis. The investigators will also aim to identify other plaque features that may have an important role in predicting stroke risk. Documenting the timescale of change in plaque volume will aid us in defining appropriate timescales for treating the symptomatic population and when those having medical management's risk has returned to baseline. Observing the change in plaque immediately after stroke will improve our knowledge of the changes in plaques that lead to symptoms and may in the future help us predict which patients with asymptomatic carotid stenosis need operation.

Conditions

Carotid Artery Diseases; Stroke; Transient Ischemic Attack

Outcome Measures

Primary Outcomes (1)

• Changes in Carotid Plaque Volume using 3-D tomographic Ultrasound over time following acute cerebral event.

  Measured by 3-D tUS with contrast administration

  Measured at 5 separate timepoints up to 12 weeks following acute cerebral event.

Secondary Outcomes (2)

• Identify adverse morphological features within the carotid plaque by 3-D tomographic Ultrasound.

  At five timepoints over 12 weeks.

• Assess the acute inflammatory response to stroke on platelet aggregation and resistance to antiplatelet agents.

  Twice during study period

Interventions

3 Dimensional tomographic Ultrasound DIAGNOSTIC_TEST

3-D tUS at five timepoints following acute ipsilateral stroke or Transient Ischaemic attack (TIA) to document carotid plaque volume and presence or absence of adverse plaque features.

Platelet Aggregometry DIAGNOSTIC_TEST

Blood test to test for platelet resistance to aspirin or clopidogrel and to measure effect of acute inflammatory response post event.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with recent stroke, with carotid artery disease not being considered for surgery.

You may qualify if:

• Patients with capacity to give informed consent. All patients who have suffered a Partial Anterior Circulatory Stroke (PACS) or Transient Ischaemic Attack (TIA).
• Carotid Stenosis \>50%.

You may not qualify if:

• Lacking capacity. Carotid Artery occlusion. Allergy to contrast agent. Significant disability or immobility such that participation would cause stress.

Sponsors & Collaborators

• University of Manchester: lead
• Manchester University NHS Foundation Trust: collaborator

Study Sites (3)

Manchester University hospitals NHS Foundation Trust

Manchester, Greater Manchester, M23 9LT, United Kingdom

Location

Northern Care Alliance, Salford Royal NHS Foundation Trust

Manchester, Greater Manchester, United Kingdom

Location

Manchester Foundation Trust, Wythenshawe site.

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Carotid Artery Diseases; Stroke; Ischemic Attack, Transient

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia

Study Officials

• Charles McCollum, Prof.

  University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Carotid Clinical Research Fellow

Study Record Dates

• First Submitted: October 25, 2018
• First Posted: October 26, 2018
• Study Start: November 1, 2018
• Primary Completion: September 9, 2021
• Study Completion: September 9, 2021
• Last Updated: September 27, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)