Utility of the Cardiac Electrical BiomarkerDisease (VECTRA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03498105|
Recruitment Status : Unknown
Verified April 2018 by Bev Hoddell, Milton Keynes University Hospital NHS Foundation Trust.
Recruitment status was: Recruiting
First Posted : April 13, 2018
Last Update Posted : April 13, 2018
|Condition or disease|
|Acute Chest Syndrome|
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:
- Acute chest pain assessment in the A&E department.
- Acute chest pain assessment in the Primary Care Surgery.
- Performance of CEB during inducible ischaemia in patients with stable angina
- Performance of CEB during acute ischaemia in patients undergoing percutaneous coronary intervention (PCI)
- Performance of CEB in patients undergoing cardio-toxic treatment
|Study Type :||Observational|
|Estimated Enrollment :||800 participants|
|Official Title:||Utility of the Cardiac Electrical Biomarker in Patients With Ischaemic Heart Disease|
|Actual Study Start Date :||May 22, 2017|
|Estimated Primary Completion Date :||November 1, 2019|
|Estimated Study Completion Date :||December 1, 2019|
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
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.
- Diagnostic accuracy of CEB in detecting myocardial injury [ Time Frame: Day 1 ]Metrics: sensitivity, specificity, PPV, NPV
- Correlation between CEB and cardiovascular mortality [ Time Frame: 30 days and 12 months ]Cardiovascular death
- Correlation between CEB and non-fatal myocardial infarction [ Time Frame: 30 days and 12 months ]Non-fatal myocardial infarction
- Correlation between CEB and readmission with progressive angina [ Time Frame: 30 days and 12 months ]Readmission with angina after index admission
- Relationship between CEB and need for revascularisation [ Time Frame: 30 days and 12 months ]Revascularisation (surgery or Percutaneous Coronary Intervention) from index admission
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498105
|Contact: Antoanela Colda||0044 1908 firstname.lastname@example.org|
|Contact: Sara Greig||0044 1908 email@example.com|
|Principal Investigator:||Attila kardos||Milton Keynes University Hospital NHS Foundation Trust|