Stroke Clinical Trial
— iThrombusOfficial title:
In-vivo Thrombus Imaging With 18F-GP1, a Novel Platelet PET Radiotracer
Verified date | October 2021 |
Source | University of Edinburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To date, the investigators have successfully employed a radiotracer (18F-sodium fluoride) as a marker of necrotic inflammation in human atherosclerosis. The investigators aim to further the mechanistic understanding of atherothrombosis by studying the activation of glycoprotein IIb/IIIa receptors in cardiovascular thrombus using the novel platelet radiotracer (18F-GP1). Binding of 18F-GP1 to activated platelets in venous and arterial thrombi has already been demonstrated in pre-clinical studies and a phase 1 trial in man. If successful, this study would define the role of the glycoprotein IIb/IIIa receptor within in vivo thrombosis across a range of cardiovascular diseases.
Status | Completed |
Enrollment | 73 |
Est. completion date | October 13, 2021 |
Est. primary completion date | July 2, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | 4.2 Myocardial infarction group inclusion/exclusion criteria 4.2.1 Myocardial infarction Inclusion criteria - Male or females over the age of 40 with recent (within 7 days) type 1 myocardial infarction (21) awaiting or have undergone inpatient coronary angiography, or with suspected myocardial infarction in the context of confirmed COVID-19 requiring hospital admission. - Provision of informed consent prior to any study specific procedures 4.2.2 Myocardial infarction Exclusion Criteria Subjects should not enter the study if any of the following criteria are fulfilled - Inability or unwilling to give informed consent. - Unable to tolerate the supine position - Impaired renal function with eGFR of <30 mL/min/1.73m2 - Allergy to iodinated contrast - Severe or significant comorbidity - Women who are pregnant or breastfeeding 4.3 Stable CAD inclusion/exclusion criteria 4.3.1 Stable CAD inclusion criteria - Male or females over the age of 40 with stable coronary artery disease who have undergone a recent (<30 days) coronary angiogram + PCI - Provision of informed consent prior to any study specific procedures 4.3.2 Stable coronary disease exclusion criteria - Myocardial infarction less than 3 months ago - Inability or unwilling to give informed consent. - Unable to tolerate the supine position - Allergy to iodinated contrast - Impaired renal function with eGFR of <30 mL/min/1.73m2 - Severe or significant comorbidity - Women who are pregnant or breastfeeding 4.4 Bioprosthetic heart valve inclusion/exclusion criteria 4.4.1 Bioprosthetic aortic valve inclusion criteria - Ability to give informed consent - Males or females over 40 years of age with recent (up to 6±4 weeks) surgical bioprosthetic heart valve replacement (SAVR or SMVR) or transcatheter bioprosthetic heart valve insertion (TAVI or TMVR). 4.4.2 Bioprosthetic heart valve exclusion criteria - Inability to give informed consent - Pregnancy - Breastfeeding - Claustrophobia - Allergy to iodinated contrast - Liver failure - Chronic kidney disease (with estimated glomerular filtration rate <30 mL/min) - Paget's disease - Metastatic malignancy - Inability to tolerate the supine position - Women who are pregnant or breastfeeding 4.5 DVT/PE inclusion/exclusion criteria 4.5.1 DVT/PE inclusion criteria - Male or females over the age of 40 with recently confirmed (<30 days) DVT on ultrasound or PE on CTPA as per ESC diagnostic guidelines (22), or with suspected DVT or PE in the context of confirmed COVID-19 requiring hospital admission - Provision of informed consent prior to any study specific procedures 4.5.2 DVT/PE exclusion criteria - Inability or unwilling to give informed consent. - Unable to tolerate the supine position - Impaired renal function with eGFR of <30 mL/min/1.73m2 - Allergy to iodinated contrast - Contraindication to iodinated contrast agents - Severe of significant comorbidity - Women who are pregnant or breastfeeding - Contra-indication to Magnetic Resonance imaging in the 6 patients offered PET MR scanning. 4.6 Stroke and TIA inclusion/exclusion criteria 4.6.1 Stroke and TIA inclusion criteria - Male or females over the age of 40 with recently diagnosed stroke or TIA as per diagnostic criteria of the American Heart and Stroke Association guidelines (23), with or without COVID-19. - Provision of informed consent prior to any study specific procedures 4.6.2 Stroke and TIA exclusion criteria - Inability or unwilling to give informed consent. - Unable to tolerate the supine position - Impaired renal function with eGFR of <30 mL/min/1.73m2 - Allergy to iodinated contrast - Contraindication to iodinated contrast agents - Severe of significant comorbidity - Women who are pregnant or breastfeeding |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University of Edinburgh | Edinburgh |
Lead Sponsor | Collaborator |
---|---|
University of Edinburgh | British Heart Foundation |
United Kingdom,
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* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ratio of 18F-GP1 standardised uptake values (SUV's) in thrombus compared with the SUVs recorded in the blood pool. | Expression of the glycoprotein IIb/IIIa receptor (assessed by SUV) within thrombus in the arterial and venous circulation. | 6 months from end of recruitment | |
Secondary | Ratio of 18F-GP1 standardised uptake values (SUV's) in thrombus formed in each of the 5 disease states. | Expression of the glycoprotein IIb/IIIa receptor (assessed by SUV) within thrombus in the arterial and venous circulation in all 5 disease states | 6 months from end of recruitment |
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