Assessment of Thrombotic Status in Patients With Acute Coronary Syndrome

NCT02562690 | Unknown DMC

• 1 other identifier: RD2014-134
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Coronary Syndrome

Keywords

Coronary Artery Disease; Myocardial Ischemia; Arterial Occlusive Diseases; Coronary Thrombosis

Outcome Measures

Primary Outcomes (1)

• Co-primary endpoints of Major Adverse Cardiovascular Events (MACE) and major bleeding

  12 months

Secondary Outcomes (1)

• Target Lesion Revascularization

  12 months

Study Arms (1)

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

Interventions

Thrombin generation assays, TEG and GTT OTHER

Thrombin generation assays, Thromboelastography (TEG), and Global Thrombosis Test (GTT)

Acute Coronary Syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Male and female patients aged 18 years or over.

You may not qualify if:

• The patient is willing and able to understand the Patient Information Sheet and provide written informed consent.
• The patient must agree to comply with the drawing of blood samples for the assessments.
• 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.
• The patient has a history of substance abuse or demonstrates signs or clinical features of active substance abuse or psychiatric disease.
• 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.
• Any illness deemed significant by the investigator during the four (4) weeks preceding the screening period of the study.
• 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).
• Currently enrolled in an investigational device or drug trial.

Sponsors & Collaborators

• University of Hertfordshire: lead
• East and North Hertfordshire NHS Trust: collaborator

Study Sites (1)

Hertfordshire Cardiology Centre, East and North Hertfordshire NHS Trust

Hertfordshire, SG1 4AB, United Kingdom

RECRUITING

Related Publications (3)

• Kraler S, Liberale L, Tirandi A, Moriero M, Wang Y, Farag M, Carbone F, Bertolotto MB, Pusterla V, Ramoni D, Ministrini S, Puspitasari YM, Bruno F, Raber L, Di Vece D, Templin C, Muller O, Mach F, Crea F, Camici GG, Lapikova-Bryhinska T, Akhmedov A, von Eckardstein A, Gorog DA, Montecucco F, Luscher TF. The junctional protein associated with coronary artery disease predicts adverse cardiovascular events in patients with acute coronary syndromes at high residual risk. Eur Heart J. 2025 Dec 23:ehaf979. doi: 10.1093/eurheartj/ehaf979. Online ahead of print.

  PMID: 41430589 DERIVED

• Farag M, Spinthakis N, Gue YX, Srinivasan M, Sullivan K, Wellsted D, Gorog DA. Impaired endogenous fibrinolysis in ST-segment elevation myocardial infarction patients undergoing primary percutaneous coronary intervention is a predictor of recurrent cardiovascular events: the RISK PPCI study. Eur Heart J. 2019 Jan 14;40(3):295-305. doi: 10.1093/eurheartj/ehy656.

  PMID: 30380032 DERIVED

• Farag M, Spinthakis N, Srinivasan M, Sullivan K, Wellsted D, Gorog DA. Morphine Analgesia Pre-PPCI Is Associated with Prothrombotic State, Reduced Spontaneous Reperfusion and Greater Infarct Size. Thromb Haemost. 2018 Mar;118(3):601-612. doi: 10.1055/s-0038-1629896. Epub 2018 Feb 14.

  PMID: 29444530 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Acute Coronary Syndrome; Coronary Artery Disease; Myocardial Ischemia; Arterial Occlusive Diseases; Coronary Thrombosis

Interventions

Thrombelastography; Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Thrombosis; Embolism and Thrombosis

Intervention Hierarchy (Ancestors)

Blood Coagulation Tests; Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Blood Chemical Analysis; Clinical Chemistry Tests; Diagnostic Techniques, Endocrine

Study Officials

• Prof. Diana A Gorog, MD, PhD

  East and North Hertfordshire NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Mohamed Farag, MSc

CONTACT

mohamedfarag@nhs.net

Prof. Diana A Gorog, MD, PhD

CONTACT

d.gorog@imperial.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 27, 2015
• First Posted: September 29, 2015
• Study Start: March 1, 2015
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: May 11, 2016

Record last verified: 2016-05

Locations

GB (1)