Ignite Creation Date:
2024-05-06 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 2:30 PM
Study NCT ID:
NCT05330819
Status:
UNKNOWN
Last Update Posted:
2022-04-15
First Post:
2021-12-02
Brief Title:
Thrombogenicity of Lipoprotein A Laboratory Study Defining the Prothrombotic Effects of Lipoprotein A
Sponsor:
South Tees Hospitals NHS Foundation Trust
Organization:
South Tees Hospitals NHS Foundation Trust
Study Overview
Official Title:
Thrombogenicity of Lipoprotein A a Prospective Non - Randomised Open Label Proof of Concept Laboratory Study Defining the Prothrombotic Effects of Lipoprotein A
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Brief summary Lipoprotein a Lpa is an independent risk factor for cardiovascular and cerebrovascular disease Traditionally the pathogenic role of Lpa has been linked to the atherogenic process given its similarity to low density lipoprotein LDL however there is a potential for prothrombotic tendencies given its resemblance to plasminogen The emerging evidence suggests that the prothrombotic properties of Lpa contribute not only to arterial but also to venous thrombosis Lpa has the potential to participate in thrombogenesis via several mechanisms probable platelet aggregation and activation increased expression of plasminogen activator inhibitor - 1 and reduced production of plasmin Prior data suggests that Lpa can also modify fibrin clot permeability and its susceptibility to lysis These observations have potentially important implications in patients with a history of myocardial infarction stroke and venous thromboembolic disease
The investigators propose to conduct a proof-of-concept study to assess the prothrombotic effects of Lpa using both quantitative and qualitative assessment of thrombosis in particular analysing clot structure and dynamics
The investigators propose to conduct a proof-of-concept study to assess the prothrombotic effects of Lpa using both quantitative and qualitative assessment of thrombosis in particular analysing clot structure and dynamics
Detailed Description:
Thrombogenicity of Lpa study is a two-centre open-label non-randomised observational laboratory study defining the prothrombotic effects of Lpa The study is aimed to answer the question of effect of LPa on thrombus formation in patients with previous history of myocardial infarction Blood thrombogenicity in patients with previous history of myocardial infarction will be studied using the following techniques
i Badimon chamber this will assess thrombogenicity of flowing blood Approximately 50 mls of blood drawn from the antecubital vein will be passed through the chamber at 37 degrees C The chamber will contain strips of porcine aorta denuded of its intima layer to promote thrombosis The resulting thrombus will be fixed in formalin stained with haematoxylineosin and the amount of thrombus quantified using the Image ProPlus software
ii Scanning electron microscope SEM A sample of the resulting thrombus from the above experiment will be gold stained and the thrombus ultrastructure analysed under SEM This will allow for examination and analysis of the microstructure morphology and characterization of the thrombus
iii Thromboelastography TEG is a comprehensive assay of the overall clotting process a method used to provide a global assessment of whole blood coagulation and clot lysis
i Badimon chamber this will assess thrombogenicity of flowing blood Approximately 50 mls of blood drawn from the antecubital vein will be passed through the chamber at 37 degrees C The chamber will contain strips of porcine aorta denuded of its intima layer to promote thrombosis The resulting thrombus will be fixed in formalin stained with haematoxylineosin and the amount of thrombus quantified using the Image ProPlus software
ii Scanning electron microscope SEM A sample of the resulting thrombus from the above experiment will be gold stained and the thrombus ultrastructure analysed under SEM This will allow for examination and analysis of the microstructure morphology and characterization of the thrombus
iii Thromboelastography TEG is a comprehensive assay of the overall clotting process a method used to provide a global assessment of whole blood coagulation and clot lysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None