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

April 14, 2022 updated by: South Tees Hospitals NHS Foundation Trust

Thrombogenicity of Lipoprotein A: a Prospective, Non - Randomised, Open Label, Proof of Concept, Laboratory Study Defining the Prothrombotic Effects of Lipoprotein A

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Thrombogenicity of Lp(a) study is a two-centre, open-label, non-randomised, observational laboratory study defining the prothrombotic effects of Lp(a). The study is aimed to answer the question of effect of LP(a) 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 haematoxylin/eosin 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 Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • Teesside
      • Middlesbrough, Teesside, United Kingdom, TS4 3BW
        • South Tees Hospitals NHS FT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Accepts healthy volunteers: patients with previous history of MI included

Description

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group and Interventions
Participants: Adult patients with stable coronary artery disease and previous history of myocardial infarction currently receiving aspirin monotherapy.
Other: Non-interventional
Blood thrombogenicity in patients with previous history of myocardial infarction will be studied using Badimon perfusion chamber, SEM and TEG.
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
Blood thrombogenicity in patients with previous history of myocardial infarction will be studied using Badimon perfusion chamber, SEM and TEG.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LP(a) thrombogenicity
Time Frame: Through study completion, an average of 1 year
Quantity of thrombus measured following Badimon Perfusion Chamber Test
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Tees Hospitals NHS Foundation Trust

Collaborators

Newcastle-upon-Tyne Hospitals NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 1, 2022

Primary Completion (ANTICIPATED)

August 1, 2022

Study Completion (ANTICIPATED)

September 1, 2022

Study Registration Dates

First Submitted

December 2, 2021

First Submitted That Met QC Criteria

April 14, 2022

First Posted (ACTUAL)

April 15, 2022

Study Record Updates

Last Update Posted (ACTUAL)

April 15, 2022

Last Update Submitted That Met QC Criteria

April 14, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 297224

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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