Health TrialsbyHealthPanel

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

ConditionsStrokePETThrombosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Edinburgh

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

120 patients following acute ischaemic stroke

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 18F-GP1 PET/CT

    Diagnostic test

    Patient will receive 1 18F-GP1 PET/CT

  • Agitated Contrast Echocardiogram

    Diagnostic test

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

  • MRI Head

    Diagnostic test

    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.

  • ECG Monitoring

    Diagnostic test

    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.

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Ischaemic Stroke4 interventions

Trial outcomes

Primary outcomes

1

The primary outcome measure will be the degree and location of platelet activation as determined by the target to background ratio of 18F-GP1.

Time frame
< 21 days

Secondary outcomes

1

Measuring the presence of platelet activation in cardio-embolic, artery to artery and in situ arterial thrombosis.

Time frame
< 21 days
2

Identifying the presence and site of platelet activation in cryptogenic and lacunar strokes.

Time frame
< 21 days
3

Identifying sites of platelet activation in patients with atrial fibrillation or atrial flutter.

Time frame
< 21 days
4

Correlation and comparison between platelet activation with excised carotid atheroma in patients referred for carotid endarterectomy.

Time frame
< 21 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Edinburgh

Lead sponsor

British Heart Foundation

Collaborator

Source ClinicalTrials.gov
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