Utility of the Cardiac Electrical BiomarkerDisease

• Conditions: Acute Chest Syndrome

• Registration Number: NCT03498105
• Lead Sponsor: Joanne Turner

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

Study Timeline

• Study Start: 2017-05-22
• Study First Submitted: 2017-09-08
• Study First Submitted QC: 2018-04-06
• Study First Posted: 2018-04-13
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-28
• Last Update Posted: 2022-03-15
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of CEB in detecting myocardial injury	Day 1	Metrics: sensitivity, specificity, PPV, NPV

Secondary Outcome Measures

Name	Time	Method
Correlation between CEB and readmission with progressive angina	30 days and 12 months	Readmission with angina after index admission
Correlation between CEB and non-fatal myocardial infarction	30 days and 12 months	Non-fatal myocardial infarction
Relationship between CEB and need for revascularisation	30 days and 12 months	Revascularisation (surgery or Percutaneous Coronary Intervention) from index admission
Correlation between CEB and cardiovascular mortality	30 days and 12 months	Cardiovascular death

Trial Locations

Locations (1)

Milton Keynes University Hospital NHS Foundation Trust; 🇬🇧 Milton Keynes, Bucks, United Kingdom