Utility of the Cardiac Electrical BiomarkerDisease (VECTRA)

February 28, 2022 updated by: Joanne Turner

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing investigations for Ischaemic heart disease and cardio-toxic effects of chemotherapy

Description

  1. 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

  2. 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

  3. 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

  4. 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
  5. 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Emergency Department (ED)

450-500 participants who will;

  1. self present to the Emergency Department (ED) will chest pain
  2. be brought in by ambulance to ED with acute chest pain
  3. 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of CEB in detecting myocardial injury
Time Frame: Day 1
Metrics: sensitivity, specificity, PPV, NPV
Day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Correlation between CEB and cardiovascular mortality
Time Frame: 30 days and 12 months
Cardiovascular death
30 days and 12 months
Correlation between CEB and non-fatal myocardial infarction
Time Frame: 30 days and 12 months
Non-fatal myocardial infarction
30 days and 12 months
Correlation between CEB and readmission with progressive angina
Time Frame: 30 days and 12 months
Readmission with angina after index admission
30 days and 12 months
Relationship between CEB and need for revascularisation
Time Frame: 30 days and 12 months
Revascularisation (surgery or Percutaneous Coronary Intervention) from index admission
30 days and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Joanne Turner

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Attila kardos, Milton Keynes University Hospital NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 22, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16-MK-008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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