In-vivo Thrombus Imaging With 18F-GP1, a Novel Platelet PET Radiotracer

NCT03943966 | Completed

• 1 other identifier: AC18071
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thrombosis; Atherothrombosis; Myocardial Infarction; STEMI; NSTEMI - Non-ST Segment Elevation MI; DVT; Pulmonary Embolism; Stroke; Transient Ischemic Attack; Prosthetic Valve Thrombosis; PET

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Ratio of 18F-GP1 standardised uptake values (SUV's) in thrombus formed in each of the 5 disease states.

  6 months from end of recruitment

Study Arms (5)

Myocardial Infarction

EXPERIMENTAL

Diagnostic Test: 18F-GP1 PET CT

Stable coronary disease with intracoronary stent insertion

ACTIVE COMPARATOR

Diagnostic Test: 18F-GP1 PET CT

Deep vein thrombosis and Pulmonary embolus

ACTIVE COMPARATOR

Diagnostic Test: 18F-GP1 PET CT

Surgical and Transcatheter Aortic valve replacement

ACTIVE COMPARATOR

Diagnostic Test: 18F-GP1 PET CT

Transient ischaemic attack and stroke

ACTIVE COMPARATOR

Diagnostic Test: 18F-GP1 PET CT

Interventions

18F-GP1 PET CT DIAGNOSTIC_TEST

PET CT scan using platelet radiotracer 18F-GP1

Deep vein thrombosis and Pulmonary embolus; Myocardial Infarction; Stable coronary disease with intracoronary stent insertion; Surgical and Transcatheter Aortic valve replacement; Transient ischaemic attack and stroke

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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
• 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
• 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
• 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

Sponsors & Collaborators

• University of Edinburgh: lead
• British Heart Foundation: collaborator

Study Sites (1)

University of Edinburgh

Edinburgh, United Kingdom

Location

Related Publications (27)

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Related Links

• Related Info

MeSH Terms

Conditions

Thrombosis; Myocardial Infarction; ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Pulmonary Embolism; Stroke; Ischemic Attack, Transient

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Myocardial Ischemia; Heart Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Lung Diseases; Respiratory Tract Diseases; Embolism; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single centre prospective pilot study

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: May 9, 2019
• Study Start: November 11, 2019
• Primary Completion: July 2, 2021
• Study Completion: October 13, 2021
• Last Updated: October 14, 2021

Record last verified: 2021-10

Locations

GB (1)