An observational study in Acute Chest Syndrome, sponsored by Joanne Turner. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-15.
Sponsored by Joanne Turner · Observational
This project is aiming to identify the diagnostic utility CEB (Cardiac Electrical Biomarker) in patients who are undergoing cardiac investigations.
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:
40 studies on the registry are indexed under Acute Chest Syndrome; 11 are open to participants now.
This study's planned enrollment of 800 is above the median of 133 across 10 observational studies indexed under Acute Chest Syndrome.
Browse Acute Chest Syndrome studies →Joanne Turner is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients undergoing investigations for Ischaemic heart disease and cardio-toxic effects of chemotherapy
Acute chest pain assessment in the Emergency department
Inclusion criteria
Exclusion criteria
The participant may not enter the study if ANY of the following apply:
Acute chest pain assessment in the Primary Care Surgery
Inclusion criteria
Exclusion criteria
The participant may not enter the study if ANY of the following apply:
Performance of CEB during inducible ischaemia in patients with stable angina
Inclusion criteria
Exclusion criteria
The participant may not enter the study if ANY of the following apply:
Performance of CEB during acute ischaemia in patients undergoing percutaneous coronary intervention (PCI)
Inclusion criteria
Exclusion criteria
The participant may not enter the study if ANY of the following apply:
Inclusion criteria
Exclusion criteria
The participant may not enter the study if ANY of the following apply:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
This study group will consist of 450-500 participants with stable angina who have been referred for Stress Echocardiography.
This study group will consist of between 50-100 participants who will have been referred for elective coronary angioplasty
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.
The dynamics and performance characteristics of the CEB during acute coronary occlusion in patients undergoing invasive coronary angiography.
Diagnostic accuracy of CEB in detecting myocardial injury
Metrics: sensitivity, specificity, PPV, NPV
Time frame: Day 1
Correlation between CEB and cardiovascular mortality
Cardiovascular death
Time frame: 30 days and 12 months
Correlation between CEB and non-fatal myocardial infarction
Non-fatal myocardial infarction
Time frame: 30 days and 12 months
Correlation between CEB and readmission with progressive angina
Readmission with angina after index admission
Time frame: 30 days and 12 months
Relationship between CEB and need for revascularisation
Revascularisation (surgery or Percutaneous Coronary Intervention) from index admission
Time frame: 30 days and 12 months
Plan to share: No
No publications or documents are linked to this record.
Started May 2017 (actual). Primary completion is estimated for Jun 2023, 73 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Joanne Turner