Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT03498105
Status:
UNKNOWN
Last Update Posted:
2022-03-15
First Post:
2017-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Utility of the Cardiac Electrical BiomarkerDisease
Sponsor:
Joanne Turner
Organization:
Study Overview
Official Title:
Utility of the Cardiac Electrical Biomarker in Patients With Ischaemic Heart Disease
Status:
UNKNOWN
Status Verified Date:
2022-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VECTRA
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: