RecruitingNCT05636748

The Origin and Role of Thromboembolism in the Pathogenesis of Ischaemic Stroke

Sponsor

University of Edinburgh

Enrollment

120 participants

Start Date

Feb 28, 2023

Study Type

OBSERVATIONAL

Conditions

Thrombosis Stroke PET

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

Min Age: 18 Years

Inclusion Criteria2

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 Criteria9

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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIAGNOSTIC_TEST18F-GP1 PET/CT

Patient will receive 1 18F-GP1 PET/CT

DIAGNOSTIC_TESTAgitated Contrast Echocardiogram

Agitated saline and ultrasound contrast will be performed to assess for intracardiac shunts and left ventricular thrombus.

DIAGNOSTIC_TESTMRI Head

Where necessary, if the CT head is normal or the clinical diagnosis of a stroke is not definite, a research MRI head will be undertaken if this has not already been performed as part of standard care.

DIAGNOSTIC_TESTECG Monitoring

All patients who do not have evidence of atrial fibrillation or atrial flutter on their 12-lead ECG will undergo an ECG Holter monitor for up to 7 days. This will be part of their standard care. If this has not been arranged by the usual care team this will be performed as a research procedure.