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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03498105
Other study ID # 16-MK-008
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 22, 2017
Est. completion date June 30, 2023

Study information

Verified date February 2022
Source Milton Keynes University Hospital NHS Foundation Trust
Contact Antoanela Colda
Phone 0044 1908 995136
Email antoanela.colda@mkuh.nhs.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This project is aiming to identify the diagnostic utility CEB (Cardiac Electrical Biomarker) in patients who are undergoing cardiac investigations.


Description:

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: 1. Acute chest pain assessment in the A&E department. 2. Acute chest pain assessment in the Primary Care Surgery. 3. Performance of CEB during inducible ischaemia in patients with stable angina 4. Performance of CEB during acute ischaemia in patients undergoing percutaneous coronary intervention (PCI) 5. Performance of CEB in patients undergoing cardio-toxic treatment


Recruitment information / eligibility

Status Recruiting
Enrollment 800
Est. completion date June 30, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 1. Acute chest pain assessment in the Emergency department Inclusion criteria - Participant is willing and able to give informed consent for participation in the study - Male or Female, aged 18 years or above Exclusion criteria The participant may not enter the study if ANY of the following apply: - Unable or unwilling to give valid consent for participation in the study - Participant has been previously recruited to another module of the VECTRA ECG study - Participant has history of allergy to ECG electrode - Noisy ECG trace in spite of appropriate preparation and elimination of mains artefact and muscle tremor - ECG tracing with a wandering baseline - Sustained or non-sustained ventricular/atrial arrhythmia (Ventricular tachycardia, supraventricular tachycardia, atrial fibrillation, bigeminy and trigeminy) - QRS duration greater than 120 milliseconds - Q waves (except positional Q waves checked by deep inspiration) - Suspected Septicaemia, pulmonary embolism or aortic dissection - Recent history of trauma to thorax - Severe renal impairment with eGFR <30 ml/min 2. Acute chest pain assessment in the Primary Care Surgery Inclusion criteria - Participant is willing and able to give informed consent for participation in the study. - Male or Female, aged 18 years or above. - Participants who have experienced chest pain more than 6 hours but less than 2 weeks of presentation to the surgery Exclusion criteria The participant may not enter the study if ANY of the following apply: - Unable or unwilling to give valid consent for participation in the study - Participant has been previously recruited to another module of the VECTRA ECG study - Participant has history of allergy to ECG electrode - Participants who have experienced 'Acute chest pain', defined as chest pain occurring less than 6 hours prior to presentation at the surgery - Participants whose initial Electrocardiogram reveals features compatible of ST elevation Myocardial Infarction - Participants whose initial Electrocardiogram reveals a Left Bundle branch block suspected to be of new onset - Noisy ECG trace in spite of appropriate preparation and elimination of mains artefact and muscle tremor - ECG tracing with a wandering baseline - Sustained or non-sustained ventricular/atrial arrhythmia (Ventricular tachycardia, Supraventricular tachycardia, atrial fibrillation, bigeminy and trigeminy) - QRS duration greater than 120 milliseconds - Q waves (except positional Q waves checked by deep inspiration) - Suspected Septicaemia, pulmonary embolism or aortic dissection - Recent history of trauma to thorax - Severe renal impairment with eGFR <30ml/min 3. Performance of CEB during inducible ischaemia in patients with stable angina Inclusion criteria - Participant is willing and able to give informed consent for participation in the study. - Male or Female, aged 18 years or above. Exclusion criteria The participant may not enter the study if ANY of the following apply: - Unable or unwilling to give valid consent for participation in the study - Participant has been previously recruited to another module of the VECTRA ECG study - Lack of adequate ultrasound acoustic window - Contraindications to undergoing stress test using dobutamine - Participant has history of allergy to ECG electrode - Noisy ECG trace in spite of appropriate preparation and elimination of mains artefact and muscle tremor - ECG tracing with a wandering baseline - Sustained or non-sustained ventricular/atrial arrhythmia (Ventricular tachycardia, supraventricular tachycardia, atrial fibrillation, bigeminy and trigeminy) - QRS duration greater than 120milliseconds - Q waves (except positional Q waves checked by deep inspiration) - Suspected Septicaemia, pulmonary embolism or aortic dissection - Recent history of trauma to thorax - Severe renal impairment with eGFR <30 ml/min 4. Performance of CEB during acute ischaemia in patients undergoing percutaneous coronary intervention (PCI) Inclusion criteria - Participant is willing and able to give informed consent for participation in the study - Male or Female, aged 18 years or above - Participant diagnosed with stable CAD or stable ACS (unstable angina or NSTEMI with no pulmonary oedema or cardiogenic shock at the time of recruitment) - Participant with Single vessel coronary artery disease or multi- vessel disease for target vessel PCI Exclusion criteria The participant may not enter the study if ANY of the following apply: - Unable or unwilling to give valid consent for participation in the study - Participant has been previously recruited to another module of the VECTRA ECG study - Participant has history of allergy to ECG electrode - Participants known to have multi-vessel coronary artery disease with one or more Chronic Total Occlusive lesions - Severe Left main coronary artery stenosis - Noisy ECG trace in spite of appropriate preparation and elimination of mains artefact and muscle tremor - ECG tracing with a wandering baseline - Sustained or non-sustained ventricular/atrial arrhythmia (Ventricular tachycardia, supraventricular tachycardia, atrial fibrillation, bigeminy and trigeminy) - QRS duration greater than 120 milliseconds - Q waves (except positional Q waves checked by deep inspiration) - Suspected Septicaemia, pulmonary embolism or aortic dissection - Recent history of trauma to thorax - Severe renal impairment with eGFR <30 ml/min 5. Performance of CEB in patients undergoing cardio-toxic treatment (type 1 and type 2 cytostatic based treatments of haemo-oncological patients Inclusion criteria - Participant is willing and able to give informed consent for participation in the study. - Male or Female, aged 18 years or above. - Participants who have been given a diagnosis of cancer and are being commenced on a chemotherapeutic drug deemed to be cardio-toxic Exclusion criteria The participant may not enter the study if ANY of the following apply: - Unable or unwilling to give valid consent for participation in the study - Participant has been previously recruited to another module of the VECTRA ECG study - Participant has history of allergy to ECG electrode - Participants previously diagnosed with Cardiomyopathy or Heart failure - Lack of adequate ultrasound acoustic window - Noisy ECG trace in spite of appropriate preparation and elimination of mains artefact and muscle tremor - ECG tracing with a wandering baseline - Sustained or non-sustained ventricular/atrial arrhythmia (Ventricular tachycardia, supraventricular tachycardia, atrial fibrillation, bigeminy and trigeminy) - QRS duration greater than 120milliseconds - Q waves (except positional Q waves checked by deep inspiration) - Suspected Septicaemia, pulmonary embolism or aortic dissection - Recent history of trauma to thorax - Severe renal impairment with eGFR <30ml/min

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United Kingdom Milton Keynes University Hospital NHS Foundation Trust Milton Keynes Bucks

Sponsors (1)

Lead Sponsor Collaborator
Joanne Turner

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnostic accuracy of CEB in detecting myocardial injury Metrics: sensitivity, specificity, PPV, NPV Day 1
Secondary Correlation between CEB and cardiovascular mortality Cardiovascular death 30 days and 12 months
Secondary Correlation between CEB and non-fatal myocardial infarction Non-fatal myocardial infarction 30 days and 12 months
Secondary Correlation between CEB and readmission with progressive angina Readmission with angina after index admission 30 days and 12 months
Secondary Relationship between CEB and need for revascularisation Revascularisation (surgery or Percutaneous Coronary Intervention) from index admission 30 days and 12 months
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