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Utility of the Cardiac Electrical BiomarkerDisease

Utility of the Cardiac Electrical Biomarker in Patients With Ischaemic Heart Disease

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03498105
Acronym
VECTRA
Enrollment
800
Registered
2018-04-13
Start date
2017-05-22
Completion date
2023-06-30
Last updated
2022-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Chest Syndrome

Keywords

Acute Chest Syndrome

Brief summary

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

Detailed 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

Interventions

None listed

Sponsors

Joanne Turner
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic accuracy of CEB in detecting myocardial injuryDay 1Metrics: sensitivity, specificity, PPV, NPV

Secondary

MeasureTime frameDescription
Correlation between CEB and cardiovascular mortality30 days and 12 monthsCardiovascular death
Correlation between CEB and non-fatal myocardial infarction30 days and 12 monthsNon-fatal myocardial infarction
Correlation between CEB and readmission with progressive angina30 days and 12 monthsReadmission with angina after index admission
Relationship between CEB and need for revascularisation30 days and 12 monthsRevascularisation (surgery or Percutaneous Coronary Intervention) from index admission

Countries

United Kingdom

Contacts

Primary ContactAntoanela Colda
antoanela.colda@mkuh.nhs.uk0044 1908 995136
Backup ContactJoanne Turner
joanne.turner@mkuh.nhs.uk01908995136

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026