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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
Sponsor:
Information provided by (Responsible Party):
Bev Hoddell, Milton Keynes University Hospital NHS Foundation Trust

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
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:

  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

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Study Type : Observational
Estimated 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
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : December 1, 2019

Group/Cohort
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.



Primary Outcome Measures :
  1. Diagnostic accuracy of CEB in detecting myocardial injury [ Time Frame: Day 1 ]
    Metrics: sensitivity, specificity, PPV, NPV


Secondary Outcome Measures :
  1. Correlation between CEB and cardiovascular mortality [ Time Frame: 30 days and 12 months ]
    Cardiovascular death

  2. Correlation between CEB and non-fatal myocardial infarction [ Time Frame: 30 days and 12 months ]
    Non-fatal myocardial infarction

  3. Correlation between CEB and readmission with progressive angina [ Time Frame: 30 days and 12 months ]
    Readmission with angina after index admission

  4. Relationship between CEB and need for revascularisation [ Time Frame: 30 days and 12 months ]
    Revascularisation (surgery or Percutaneous Coronary Intervention) from index admission



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing investigations for Ischaemic heart disease and cardio-toxic effects of chemotherapy
Criteria
  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

Information from the National Library of Medicine

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


Contacts
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Contact: Antoanela Colda 0044 1908 995136 antoanela.colda@mkuh.nhs.uk
Contact: Sara Greig 0044 1908 995136 sara.greig@mkuh.nhs.uk

Locations
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United Kingdom
Milton Keynes University Hospital NHS Foundation Trust Recruiting
Milton Keynes, Bucks, United Kingdom, MK6 5LD
Contact: Attila Kardos       Attila.Kardos@mkuh.nhs.uk   
Contact: Felicia Adjei       Felicia.Adjei@mkuh.nhs.uk   
Sponsors and Collaborators
Bev Hoddell
Investigators
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Principal Investigator: Attila kardos Milton Keynes University Hospital NHS Foundation Trust

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Responsible Party: Bev Hoddell, Academic Research Coordinator, Milton Keynes University Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03498105    
Other Study ID Numbers: 16-MK-008
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bev Hoddell, Milton Keynes University Hospital NHS Foundation Trust:
Acute Chest Syndrome
Additional relevant MeSH terms:
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Acute Chest Syndrome
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn