Clinical trial NCT03498105: Utility of the Cardiac Electrical BiomarkerDisease
Official title: Utility of the Cardiac Electrical Biomarker in Patients With Ischaemic Heart Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Chest Syndrome
Keywords: Acute Chest Syndrome
Lead sponsor: Milton Keynes University Hospital NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2018-04-13
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing investigations for Ischaemic heart disease and cardio-toxic effects of chemotherapy

Brief summary: 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:

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

Eligibility 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

Primary outcomes:
measure: Diagnostic accuracy of CEB in detecting myocardial injury
timeFrame: Day 1
Secondary outcomes:
measure: Correlation between CEB and cardiovascular mortality
timeFrame: 30 days and 12 months
measure: Correlation between CEB and non-fatal myocardial infarction
timeFrame: 30 days and 12 months
measure: Correlation between CEB and readmission with progressive angina
timeFrame: 30 days and 12 months
measure: Relationship between CEB and need for revascularisation
timeFrame: 30 days and 12 months
Other outcomes:
Locations:
city: Milton Keynes
country: United Kingdom
facility: Milton Keynes University Hospital NHS Foundation Trust
state: Bucks
Study officials:
affiliation: Milton Keynes University Hospital NHS Foundation Trust
name: Attila kardos
role: PRINCIPAL_INVESTIGATOR
References: