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This project is aiming to identify the diagnostic utility CEB (Cardiac Electrical Biomarker) in patients who are undergoing cardiac investigations.
This project is aiming to identify the diagnostic utility of an ECG derived measurement by a Medical device (Vectraplex by VectraCor ltd) in patients who are undergoing cardiac investigations. This technology is based on the principle of vector ECG and an analysing system that computes a composite score termed a Cardiac Electrical Biomarker (CEB TM).
CEB has been validated in the detection of STEMI with high sensitivity and specificity in the detection ECG changes characteristic to STEMI. The CEB may be a more accurate way of identifying heart injury and causes of chest pain compared to standard tests, which could lead to faster diagnosis and treatment of these patients.
The diagnostic utility of the CEBTM in the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Emergency Department (ED) | 450-500 participants who will;
| ||
| Community Cardiology Service (CCS) | This study group will consist of between 80-100 participants who self present to the Community Cardiology Service (CCS) in Milton Keynes primary care surgery | ||
| Participants with stable angina | This study group will consist of 450-500 participants with stable angina who have been referred for Stress Echocardiography. | ||
| Elective Coronary Angioplasty | This study group will consist of between 50-100 participants who will have been referred for elective coronary angioplasty | ||
| Cardio-toxic Chemotherapy | Consecutive patients being initiated on any of the following medication deemed as cardio toxic and requiring cardiac function will be approached to be recruited into the study. | ||
| Invasive Coronary Angiography | The dynamics and performance characteristics of the CEB during acute coronary occlusion in patients undergoing invasive coronary angiography. |
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| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy of CEB in detecting myocardial injury | Metrics: sensitivity, specificity, PPV, NPV | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between CEB and cardiovascular mortality | Cardiovascular death | 30 days and 12 months |
| Correlation between CEB and non-fatal myocardial infarction | Non-fatal myocardial infarction |
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Acute chest pain assessment in the Emergency department
Inclusion criteria
Exclusion criteria
The participant may not enter the study if ANY of the following apply:
Acute chest pain assessment in the Primary Care Surgery
Inclusion criteria
Exclusion criteria
The participant may not enter the study if ANY of the following apply:
Performance of CEB during inducible ischaemia in patients with stable angina
Inclusion criteria
Exclusion criteria
The participant may not enter the study if ANY of the following apply:
Performance of CEB during acute ischaemia in patients undergoing percutaneous coronary intervention (PCI)
Inclusion criteria
Exclusion criteria
The participant may not enter the study if ANY of the following apply:
Performance of CEB in patients undergoing cardio-toxic treatment (type 1 and type 2 cytostatic based treatments of haemo-oncological patients
Inclusion criteria
Exclusion criteria
The participant may not enter the study if ANY of the following apply:
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Patients undergoing investigations for Ischaemic heart disease and cardio-toxic effects of chemotherapy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antoanela Colda | Contact | 0044 1908 995136 | antoanela.colda@mkuh.nhs.uk | |
| Joanne Turner | Contact | 01908995136 | joanne.turner@mkuh.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Attila kardos | Milton Keynes University Hospital NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Milton Keynes University Hospital NHS Foundation Trust | Recruiting | Milton Keynes | Bucks | MK6 5LD | United Kingdom |
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| ID | Term |
|---|---|
| D056586 | Acute Chest Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D000755 | Anemia, Sickle Cell |
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| 30 days and 12 months |
| Correlation between CEB and readmission with progressive angina | Readmission with angina after index admission | 30 days and 12 months |
| Relationship between CEB and need for revascularisation | Revascularisation (surgery or Percutaneous Coronary Intervention) from index admission | 30 days and 12 months |
| D000745 |
| Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |