- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03498105
Utility of the Cardiac Electrical BiomarkerDisease (VECTRA)
Utility of the Cardiac Electrical Biomarker in Patients With Ischaemic Heart Disease
Study Overview
Status
Conditions
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:
- 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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Antoanela Colda
- Phone Number: 0044 1908 995136
- Email: antoanela.colda@mkuh.nhs.uk
Study Contact Backup
- Name: Joanne Turner
- Phone Number: 01908995136
- Email: joanne.turner@mkuh.nhs.uk
Study Locations
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Bucks
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Milton Keynes, Bucks, United Kingdom, MK6 5LD
- Recruiting
- Milton Keynes University Hospital NHS Foundation Trust
-
Contact:
- Attila Kardos
- Email: Attila.Kardos@mkuh.nhs.uk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
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
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
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
- 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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Emergency Department (ED)
450-500 participants who will;
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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
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Participants with stable angina
This study group will consist of 450-500 participants with stable angina who have been referred for Stress Echocardiography.
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Elective Coronary Angioplasty
This study group will consist of between 50-100 participants who will have been referred for elective coronary angioplasty
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Cardio-toxic Chemotherapy
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.
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Invasive Coronary Angiography
The dynamics and performance characteristics of the CEB during acute coronary occlusion in patients undergoing invasive coronary angiography.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic accuracy of CEB in detecting myocardial injury
Time Frame: Day 1
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Metrics: sensitivity, specificity, PPV, NPV
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Day 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between CEB and cardiovascular mortality
Time Frame: 30 days and 12 months
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Cardiovascular death
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30 days and 12 months
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Correlation between CEB and non-fatal myocardial infarction
Time Frame: 30 days and 12 months
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Non-fatal myocardial infarction
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30 days and 12 months
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Correlation between CEB and readmission with progressive angina
Time Frame: 30 days and 12 months
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Readmission with angina after index admission
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30 days and 12 months
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Relationship between CEB and need for revascularisation
Time Frame: 30 days and 12 months
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Revascularisation (surgery or Percutaneous Coronary Intervention) from index admission
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30 days and 12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Attila kardos, Milton Keynes University Hospital NHS Foundation Trust
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-MK-008
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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