Investigating the role of thrombus in ischaemic stroke
The Origin and Role of Thromboembolism in the Pathogenesis of Ischaemic Stroke
This study is trying to see how blood clots affect people who have had an ischaemic stroke, using special imaging to better understand their role and improve treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Edinburgh Academic / other |
| Locations | 1 site (Edinburgh) |
| Trial ID | NCT05636748 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the origin and role of thromboembolism in patients with ischaemic stroke, including those with cryptogenic and lacunar strokes. Utilizing a novel thrombus-specific radiotracer, 18F-GP1, the study will assess its effectiveness in identifying thrombus formation and its clinical implications. The research will involve various imaging techniques, including PET/CT and MRI, to provide insights into the mechanisms behind stroke and improve diagnostic accuracy. By understanding the thrombus's role, the study seeks to enhance patient management and treatment strategies.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with acute ischaemic stroke within 21 days of symptom onset.
Not a fit: Patients with haemorrhagic stroke or significant comorbidities that prevent them from completing study procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnosis and treatment options for patients suffering from ischaemic stroke.
How similar studies have performed: While the use of thrombus-specific imaging is a novel approach, preliminary studies have shown promise in similar methodologies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Males and females ≥18 years old * Diagnoses of acute ischaemic stroke (within 21 days of symptom onset) as per American Heart and Stroke Association guidelines Exclusion Criteria: * Inability or unwillingness to provide informed written consent (ie lack capacity) * Inability to undergo the scanning protocol including ability to transfer onto the scanner * Women of child- bearing potential in whom pregnancy cannot be excluded * Contraindication to PET-CT scanning including estimated glomerular filtration rate \<30 mL/min/1.73 m2 * Participation in the study would result in a delay to carotid endarterectomy surgery * Known allergy to iodinated contrast or radiotracer * Severe or significant comorbidity precluding ability to complete study procedures. * Haemorrhagic stroke * Contra-indication to Magnetic Resonance imaging for those patients requiring a MRI Head
Where this trial is running
Edinburgh
- Clinical Research Facility — Edinburgh, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Beth Whittington, MD
- Email: bwhittin@ed.ac.uk
- Phone: 01312426200
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.