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

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ClinicalTrials.gov Identifier: NCT03943966
Recruitment Status : Not yet recruiting
First Posted : May 9, 2019
Last Update Posted : May 9, 2019
Sponsor:
Collaborator:
British Heart Foundation
Information provided by (Responsible Party):
University of Edinburgh

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.

Condition or disease Intervention/treatment Phase
Thrombosis Atherothrombosis Myocardial Infarction STEMI NSTEMI - Non-ST Segment Elevation MI DVT Pulmonary Embolism Stroke Transient Ischemic Attack Prosthetic Valve Thrombosis PET Diagnostic Test: 18F-GP1 PET CT Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single centre prospective pilot study
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: In-vivo Thrombus Imaging With 18F-GP1, a Novel Platelet PET Radiotracer
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots

Arm Intervention/treatment
Experimental: Myocardial Infarction Diagnostic Test: 18F-GP1 PET CT
PET CT scan using platelet radiotracer 18F-GP1

Active Comparator: Stable coronary disease with intracoronary stent insertion Diagnostic Test: 18F-GP1 PET CT
PET CT scan using platelet radiotracer 18F-GP1

Active Comparator: Deep vein thrombosis and Pulmonary embolus Diagnostic Test: 18F-GP1 PET CT
PET CT scan using platelet radiotracer 18F-GP1

Active Comparator: Surgical and Transcatheter Aortic valve replacement Diagnostic Test: 18F-GP1 PET CT
PET CT scan using platelet radiotracer 18F-GP1

Active Comparator: Transient ischaemic attack and stroke Diagnostic Test: 18F-GP1 PET CT
PET CT scan using platelet radiotracer 18F-GP1




Primary Outcome Measures :
  1. Ratio of 18F-GP1 standardised uptake values (SUV's) in thrombus compared with the SUVs recorded in the blood pool. [ Time Frame: 6 months from end of recruitment ]
    Expression of the glycoprotein IIb/IIIa receptor (assessed by SUV) within thrombus in the arterial and venous circulation.


Secondary Outcome Measures :
  1. Ratio of 18F-GP1 standardised uptake values (SUV's) in thrombus formed in each of the 5 disease states. [ Time Frame: 6 months from end of recruitment ]
    Expression of the glycoprotein IIb/IIIa receptor (assessed by SUV) within thrombus in the arterial and venous circulation in all 5 disease states



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • 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)
  • 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)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03943966


Contacts
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Contact: Jack CM Andrews, MD 07766885010 jack.andrews@ed.ac.uk
Contact: Professor PI Newby, PhD 01315361000 d.e.newby@ed.ac.uk

Sponsors and Collaborators
University of Edinburgh
British Heart Foundation

Additional Information:
Publications:
Organisation WH. Cardiovascular diseases 2018 [Available from: www.who.int/cardiovascular_diseases/en/
Sacco RL, Kasner SE, Broderick JP, Caplan LR, Connors JJ, Culebras A, Elkind MS, George MG, Hamdan AD, Higashida RT, Hoh BL, Janis LS, Kase CS, Kleindorfer DO, Lee JM, Moseley ME, Peterson ED, Turan TN, Valderrama AL, Vinters HV; American Heart Association Stroke Council, Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular and Stroke Nursing; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Council on Nutrition, Physical Activity and Metabolism. An updated definition of stroke for the 21st century: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Jul;44(7):2064-89. doi: 10.1161/STR.0b013e318296aeca. Epub 2013 May 7.

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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT03943966     History of Changes
Other Study ID Numbers: AC18071
First Posted: May 9, 2019    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Infarction
Myocardial Infarction
Thrombosis
Embolism
Pulmonary Embolism
Ischemic Attack, Transient
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Embolism and Thrombosis
Lung Diseases
Respiratory Tract Diseases
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases