Acute Chest SyndromeVECTRANCT03498105
Utility of the Cardiac Electrical BiomarkerDisease
An observational study of Acute Chest Syndrome, run by Joanne Turner at 1 site in United Kingdom.
Trial summary
This project is aiming to identify the diagnostic utility CEB (Cardiac Electrical Biomarker) in patients who are undergoing cardiac investigations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Chest Syndrome
- How many people
- 800 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 May 2017to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing investigations for Ischaemic heart disease and cardio-toxic effects of chemotherapy
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study
- Male or Female, aged 18 years or above
- 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
- Participant is willing and able to give informed consent for participation in the study.
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- Male or Female, aged 18 years or above.
- 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
- 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
Who cannot join
- 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
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- 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
- 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
- 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)
- 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
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Milton Keynes University Hospital NHS Foundation Trust
Milton Keynes, Bucks, MK6 5LD
Attila Kardos, Attila.Kardos@mkuh.nhs.uk
About this study
Official title: 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.
Read the 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
- Conditions
- Acute Chest Syndrome
- Keywords
- Acute Chest Syndrome
- Medical subject headings
- Acute Chest Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of CEB in detecting myocardial injury
Metrics: sensitivity, specificity, PPV, NPV
Measured: Day 1
Secondary outcomes (4)
Correlation between CEB and cardiovascular mortality
Cardiovascular death
Measured: 30 days and 12 months
Correlation between CEB and non-fatal myocardial infarction
Non-fatal myocardial infarction
Measured: 30 days and 12 months
Correlation between CEB and readmission with progressive angina
Readmission with angina after index admission
Measured: 30 days and 12 months
Relationship between CEB and need for revascularisation
Revascularisation (surgery or Percutaneous Coronary Intervention) from index admission
Measured: 30 days and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start22 May 2017
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Chest SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joanne Turner
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Joanne Turner, Milton Keynes University Hospital NHS Foundation Trust
- Investigators
- Attila kardos, Principal investigator, Milton Keynes University Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03498105
- Sponsor's protocol ID
- 16-MK-008
- Acronym
- VECTRA
- Status last verified
- Feb 2022
- First submitted
- 8 Sep 2017
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of the Cardiac Electrical Biomarker in Patients With Ischaemic Heart Disease
- ClinicalTrials.gov ID
- NCT03498105
- Acronym / sponsor ID
- VECTRA / 16-MK-008
- Conditions
- Acute Chest Syndrome
- Keywords
- Acute Chest Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Joanne TurnerOther government
- Study start
- 22 May 2017 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 13 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing investigations for Ischaemic heart disease and cardio-toxic effects of chemotherapy
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (73 listed)
- 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 (type 1 and type 2 cytostatic based treatments of haemo-oncological patients
- Unable or unwilling to give valid consent for participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic accuracy of CEB in detecting myocardial injury
Time frame: Day 1
Metrics: sensitivity, specificity, PPV, NPV
4 secondary outcomes
Correlation between CEB and cardiovascular mortality
Time frame: 30 days and 12 months
Correlation between CEB and non-fatal myocardial infarction
Time frame: 30 days and 12 months
Correlation between CEB and readmission with progressive angina
Time frame: 30 days and 12 months
Relationship between CEB and need for revascularisation
Time frame: 30 days and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Attila kardos principal investigator
Milton Keynes University Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Chest Syndrome, run by Joanne Turner at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 73 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antoanela Colda (0044 1908 995136, antoanela.colda@mkuh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of CEB in detecting myocardial injury (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.