Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT03498105
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03498105
Study Brief:
Protocol Section:
NCT03498105