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| Name | Class |
|---|---|
| East and North Hertfordshire NHS Trust | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thrombin generation assays, TEG and GTT | Other | Thrombin generation assays, Thromboelastography (TEG), and Global Thrombosis Test (GTT) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Co-primary endpoints of Major Adverse Cardiovascular Events (MACE) and major bleeding | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Target Lesion Revascularization | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mohamed Farag, MSc | Contact | mohamedfarag@nhs.net | ||
| Prof. Diana A Gorog, MD, PhD | Contact | d.gorog@imperial.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Prof. Diana A Gorog, MD, PhD | East and North Hertfordshire NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hertfordshire Cardiology Centre, East and North Hertfordshire NHS Trust | Recruiting | Hertfordshire | SG1 4AB | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41430589 | Derived | 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. | |
| 30380032 |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D003324 | Coronary Artery Disease |
| D017202 | Myocardial Ischemia |
| D001157 | Arterial Occlusive Diseases |
| D003328 | Coronary Thrombosis |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D003327 | Coronary Disease |
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| ID | Term |
|---|---|
| D013916 | Thrombelastography |
| D005951 | Glucose Tolerance Test |
| ID | Term |
|---|---|
| D001780 | Blood Coagulation Tests |
| D006403 | Hematologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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Plasma
| 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. |
| 29444530 | 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. |
| D001161 |
| Arteriosclerosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D003940 | Diagnostic Techniques, Endocrine |