VECTRA: Utility of the Cardiac Electrical BiomarkerDisease

Sponsor

Joanne Turner (Other)

Overall Status

Recruiting

CT.gov ID

NCT03498105

Collaborator

(none)

800

Enrollment

Location

73.3

Anticipated Duration (Months)

10.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Acute Chest Syndrome

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 Design

Study Type:

Observational

Anticipated Enrollment :

800 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 22, 2017

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Emergency Department (ED) 450-500 participants who will; self present to the Emergency Department (ED) will chest pain be brought in by ambulance to ED with acute chest pain be referred from Primary care or Urgent care centre with cardiac sounding chest pain
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
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.
Invasive Coronary Angiography The dynamics and performance characteristics of the CEB during acute coronary occlusion in patients undergoing invasive coronary angiography.

Outcome Measures

Primary Outcome Measures

Diagnostic accuracy of CEB in detecting myocardial injury [Day 1]
Metrics: sensitivity, specificity, PPV, NPV

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Milton Keynes University Hospital NHS Foundation Trust	Milton Keynes	Bucks	United Kingdom	MK6 5LD

Sponsors and Collaborators

Joanne Turner

Investigators

Principal Investigator: Attila kardos, Milton Keynes University Hospital NHS Foundation Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Joanne Turner, Academic Research Coordinator, Milton Keynes University Hospital NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT03498105

Other Study ID Numbers:

16-MK-008

First Posted:

Apr 13, 2018

Last Update Posted:

Mar 15, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Joanne Turner, Academic Research Coordinator, Milton Keynes University Hospital NHS Foundation Trust

Acute Chest Syndrome

Additional relevant MeSH terms:

Acute Chest Syndrome

Study Results

No Results Posted as of Mar 15, 2022