NCT05636748 The Origin and Role of Thromboembolism in the Pathogenesis of Ischaemic Stroke
| NCT ID | NCT05636748 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Edinburgh |
| Condition | Stroke |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-02-28 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2023-02-28 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Ischaemic stroke is usually due to occlusion of a cerebral artery by thrombus. However, it is often difficult to identify the source of thrombus, or to confirm thrombus as a cause of ischaemic stroke. Moreover, it is debated whether thrombosis plays any role in certain types of stroke such as lacunar stroke. In preliminary studies, the investigators have evaluated a novel clinical grade thrombus-specific radiotracer, 18F-GP1, which has a high specificity for the glycoprotein IIb/IIIa receptor on activated platelets. The investigations have demonstrated that 18F-GP1 is highly sensitive to in vivo thrombus formation and demonstrates avid binding to thrombus associated with myocardial infarction, pulmonary embolism and aortic bioprosthesis. This study will use this imaging approach to define the role and origin of thrombus in patients with ischaemic stroke, cryptogenic stroke and lacunar stroke.The investigators will also assess its added clinical value in assessing patients with ischaemic stroke.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05636748 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05636748 currently recruiting?
Yes, NCT05636748 is actively recruiting participants. Contact the research team at bwhittin@ed.ac.uk for enrollment information.
Where is the NCT05636748 trial being conducted?
This trial is being conducted at Edinburgh, United Kingdom.
Who is sponsoring the NCT05636748 clinical trial?
NCT05636748 is sponsored by University of Edinburgh. The trial plans to enroll 120 participants.
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