Thrombogenicity of Lipoprotein A: Laboratory Study Defining the Prothrombotic Effects of Lipoprotein A

NCT05330819 | Unknown

• 1 other identifier: 297224
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Brief summary: Lipoprotein a (Lp(a)) is an independent risk factor for cardiovascular and cerebrovascular disease. Traditionally, the pathogenic role of Lp(a) 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 Lp(a) contribute not only to arterial but also to venous thrombosis. Lp(a) 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 Lp(a), 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 Lp(a), using both quantitative and qualitative assessment of thrombosis, in particular analysing clot structure and dynamics.

Conditions

Cardiovascular Disease and Lipid Disorders; Cardiac Disease

Outcome Measures

Primary Outcomes (1)

• LP(a) thrombogenicity

  Quantity of thrombus measured following Badimon Perfusion Chamber Test

  Through study completion, an average of 1 year

Study Arms (2)

Group and Interventions

Participants: Adult patients with stable coronary artery disease and previous history of myocardial infarction currently receiving aspirin monotherapy.

Other: Non-interventional

Groups and interventions

Interventions: Blood thrombogenicity in patients with previous history of myocardial infarction will be studied using Badimon perfusion chamber, SEM and TEG.

Other: Non-interventional

Interventions

Non-interventional OTHER

Blood thrombogenicity in patients with previous history of myocardial infarction will be studied using Badimon perfusion chamber, SEM and TEG.

Group and Interventions; Groups and interventions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Accepts healthy volunteers: patients with previous history of MI included

You may qualify if:

• Adult patients with stable coronary artery disease and previous history of myocardial infarction currently receiving aspirin monotherapy;
• Age ≥ 18;
• Patients who can provide written informed consent for participation in the trial;

You may not qualify if:

• Haematological disorders (anaemia, malignancy, bleeding disorder)
• Malignancy (currently diagnosed or under investigation)
• Current smokers
• Chronic liver disease
• End stage renal disease (eGFR\<30ml/min)
• Use of corticosteroids or non-steroidal anti-inflammatory agents
• Patients taking aspirin at dose of above 75mg daily
• Patients receiving anticoagulant treatment or antiplatelet treatment other than aspirin
• Unable to consent

Sponsors & Collaborators

• South Tees Hospitals NHS Foundation Trust: lead
• Newcastle-upon-Tyne Hospitals NHS Trust: collaborator

Study Sites (1)

South Tees Hospitals NHS FT

Middlesbrough, Teesside, TS4 3BW, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Biospecimen retention: samples of resulting thrombus following Badimon perfusion chamber will be retained for SEM analysis

MeSH Terms

Conditions

Cardiovascular Diseases; Lipid Metabolism Disorders; Heart Diseases

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Doctor

CONTACT

01325 381100; pyotr.telyuk@nhs.net

Doctor

CONTACT

01642 850850; david.austin@nhs.net

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: April 15, 2022
• Study Start: May 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: September 1, 2022
• Last Updated: April 15, 2022

Record last verified: 2022-04

Locations

GB (1)