Assessment of Thrombotic Status in Patients With Acute Coronary Syndrome

May 10, 2016 updated by: Diana A Gorog, University of Hertfordshire
Impaired thrombotic status is associated with adverse cardiovascular events. Patients with acute coronary syndrome (ACS) are at increased cardiovascular risk. The aim of the study is to determine the usefulness of thrombotic status assessment in a large cohort of ACS patients, managed with contemporary treatments, to identify patients at risk of thrombosis and those at risk of bleeding complications.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients presenting with acute coronary syndrome (ACS) are at increased risk of future cardiovascular events, despite optimal medical treatment and coronary intervention. Such events are usually caused by increased stickiness of the blood causing a blood clot (thrombus) to block arterial blood vessels in the heart. Much of the medication to prevent recurrent thrombotic events increases the risk of bleeding complications. Identification of patients at recurrent thrombotic risk could allow targeted treatment with potent antithrombotic medications, with less potent agents in others to reduce bleeding. The investigators will assess the stickiness of the blood (i.e. thrombotic status) in patients who are admitted to hospital with ACS; at baseline, at discharge from hospital and at 30 days post hospitalisation. Blood stickiness will be tested using a number of tests of thrombotic status including thrombin generation assays, Thromboelastography (TEG) and the near-patient, point-of-care Global Thrombosis Test (GTT). The results will be evaluated to assess the effect of disease process and clinical state on blood stickiness to gain further understanding of the condition and form the basis for future studies aimed at identifying patients who are at high risk of future cardiovascular events.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

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

Study Locations

  • United Kingdom
      • Hertfordshire, United Kingdom, SG1 4AB
        • Recruiting
        • Hertfordshire Cardiology Centre, East and North Hertfordshire NHS Trust
        • Contact:
        • Principal Investigator:
          • Prof. Diana A Gorog, MD, PhD
        • Sub-Investigator:
          • Dr. Mohamed Farag, MSc

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

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Acute Coronary Syndrome (ACS) Patients. ACS patients will comprise of patients admitted to hospital with suspected cardiac chest pain and at least 2 of the following 3 criteria of (1) chest pain, (2) ischaemic ECG changes (3) a cardiac troponin measurement exceeding the 99th percentile of a normal reference population (upper reference limit).

Description

Inclusion Criteria:

  1. Male and female patients aged 18 years or over.
  2. Patients diagnosed with ACS and free of exclusion criteria below.
  3. The patient is willing and able to understand the Patient Information Sheet and provide written informed consent.
  4. The patient must agree to comply with the drawing of blood samples for the assessments.

Exclusion Criteria:

  1. The patient has, in the opinion of the investigator, significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, haemorrhagic, metabolic or other disease likely to confound the study requirements or analyses.
  2. The patient has a history of substance abuse or demonstrates signs or clinical features of active substance abuse or psychiatric disease.
  3. Alcohol consumption above recommended safe levels (i.e. more than 21 units per week for males, or more than 14 units per week for females) due to the potential effects of high alcohol levels on platelet reactivity.
  4. Any illness deemed significant by the investigator during the four (4) weeks preceding the screening period of the study.
  5. Any major bleeding diathesis or blood dyscrasia (platelets < 70 x 109/l, Hb < 8 g/dl, INR > 1.4, APTT > x 2 UNL, leucocyte count < 3.5 x 109/l, neutrophil count < 1 x 109/l).
  6. Currently enrolled in an investigational device or drug trial.

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
Acute Coronary Syndrome

Patients with acute chest pain and persistent ST-segment elevation or new left bundle branch block on the 12 lead ECG. This is termed ST-segment Elevation Myocardial Infarction (STEMI).

Patients with acute chest pain but without persistent ST-segment elevation. These patients, based on the measurement of cardiac biomarker values (troponin), will be further classified as Non-ST-segment Elevation Myocardial Infarction (NSTEMI) or unstable angina.

Where possible, all patients will have tests of thrombotic status including thrombin generation assays, TEG and GTT.
Other: Thrombin generation assays, TEG and GTT
Thrombin generation assays, Thromboelastography (TEG), and Global Thrombosis Test (GTT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Co-primary endpoints of Major Adverse Cardiovascular Events (MACE) and major bleeding
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Target Lesion Revascularization
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

University of Hertfordshire

Collaborators

East and North Hertfordshire NHS Trust

Investigators

  • Principal Investigator: Prof. Diana A Gorog, MD, PhD, East and North Hertfordshire NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2015

Primary Completion (Anticipated)

February 1, 2020

Study Completion (Anticipated)

February 1, 2020

Study Registration Dates

First Submitted

September 27, 2015

First Submitted That Met QC Criteria

September 28, 2015

First Posted (Estimate)

September 29, 2015

Study Record Updates

Last Update Posted (Estimate)

May 11, 2016

Last Update Submitted That Met QC Criteria

May 10, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD2014-134

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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