Examining the difference between stroke patients and asymptomatic patients with carotid atherosclerosis

Not Applicable

• Conditions: Stroke; Carotid atherosclerosis; Stroke - Ischaemic; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12619001021167
• Lead Sponsor: Royal North Shore Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-16
• Study Completion: 2021-02-12
• Last Update Posted: 21 July 2021

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

1. Male or female patients > 50 years of age;

AND

2. Carotid plaque unilaterally or bilaterally resulting in internal carotid artery stenosis >50% on duplex ultrasonography

AND
3. Either
a) A Previous stroke or transient ischaemic attack (TIA) in the vascular territory of all affected internal carotid arteries
OR
b) Previous stroke or transient ischaemic attack in the vascular territory of the one affected internal carotid artery
OR
c) No previous stroke or transient ischaemic attack in the vascular territory of any internal carotid arteries

Exclusion Criteria

1. Pregnancy or breast-feeding;
2. Inability to lie in a supine position on the PET scanning bed for 15 minutes;
3. Subjects who required sedation for their baseline clinical PET/CT scan;
4. Renal failure requiring haemo- or peritoneal dialysis;
5. Substance abuse, medical, psychological or social conditions that in the opinion of the investigator may interfere with the patient’s participation in the study or evaluation of the study results;
6. Atrial fibrillation or known cardiogenic cause of stroke
7. Recent vascular surgery or intervention surgery

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
FMISO uptake in carotid arteries[For those who have had an ischaemic event, the PET scan will take place 2-14 days after ischaemic event. The scan can occur on different day to the MRI scan and there is no time limit between scans provided both are completed within 14 days to the ischaemic event.<br><br>The FMISO uptake is assessed in both patients arms (both those who have and those who have not had an ischaemic event)]

Secondary Outcome Measures

Name	Time	Method
MRI black blood sequence [For those who have had an ischaemic event, the MRI scan will take place 2-14 days after ischaemic event. The scan can occur on different day to the PET scan and there is no time limit between scans provided both are completed within 14 days to the ischaemic event.<br><br>The MRI scan is assessed in both patients arms (both those who have and those who have not had an ischaemic event)];MRI 4D flow in carotid arteries[The MRI blood flow in carotids will take place at the same time as the MRI black blood sequence scan]