Acute Coronary SyndromeCOGNITIONNCT02803931
Assessing the Efficacy of CardiOGoniometry (CGM) to Localise the Culprit Vessel in Mixed Vessel Disease Non-ST elevatIon Myocardial infarcTION (NSTEMI)
A study testing Cardiogoniometry and 12-lead ECG in people with Acute Coronary Syndrome, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
This study aims to test the hypothesis that cardiogoniometry (CGM) is helpful to identify the site of the culprit vessel in patients with NSTEMI in comparison to 12-lead ECG. NSTEMI constitutes a clinical syndrome subset of acute coronary syndrome which is most usually caused by atherosclerotic coronary artery… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Cardiogoniometry and 12-lead ECG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Sep 2015to 6 Sep 2016
- Phase
- Interventional
- 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
Who may be able to join
- Patients admitted with NSTEMI.
- Patients who have been consented to undergo coronary angiography +/- PCI as part of their routine care by their clinician.
- Aged 18 or over.
- The patient has been informed of the nature of the study and has provided full written informed consent.
Who cannot join
- Patients unable to give informed consent including those with communication difficulties due to poor English.
- Patients with on-going chest pain at rest despite medical therapy
- Patients with haemodynamic instability and / or cardiogenic shock (defined as a sustained blood pressure of <90mmHg +/- the need for inotropic support)
- Patients with STEMI
- Those unable to perform a good quality CGM: 1) Patients who are SOB at rest; 2) Patients with very frequent ectopic beat; 3) Patients in atrial fibrillation; 4) Patients with a heart rate >150 beats/min
- Patients with previous coronary artery bypass graft surgery
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- Patients who are unable to receive treatment with heparin
- Patients with significant renal impairment (defined as eGFR<30ml/min)
- Females who are or could be pregnant
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Castle Hill Hospital
Hull, East Yorkshire, HU16 5JQ
About this study
This study aims to test the hypothesis that cardiogoniometry (CGM) is helpful to identify the site of the culprit vessel in patients with NSTEMI in comparison to 12-lead ECG.
NSTEMI constitutes a clinical syndrome subset of acute coronary syndrome which is most usually caused by atherosclerotic coronary artery disease. It is defined by "electrocardiographic (ECG) ST-segment depression or prominent T-wave inversion and/or positive biomarkers of necrosis (e.g., troponin) in the absence of ST-segment elevation and in an appropriate clinical setting (chest discomfort or angina equivalent)". The standard 12 lead ECG is not commonly sensitive at localising the site of the culprit lesion and even coronary angiography may not always be helpful as the majority of lesions will not have angiographically evident thrombus. Patients with an ACS may have multivessel disease and it is often not possible to identify the precise site of the culprit lesion. In patients with multivessel disease, interventionists will frequently target the most severe stenosis even though this is not necessarily the acute lesion.
Read more
CGM (Cardiogoniometry cardiologic explorer, Enverdis GmbH medical solutions, Germany) is a form of 3D vector electrocardiography which can provide quantitative analysis of myocardial depolarisation and repolarisation. It has CE mark and has been shown to be more sensitive and specific than standard 12-lead ECG at diagnosing stable coronary artery disease. Furthermore, recent work has shown CGM to be more sensitive at detecting patients with NSTEMI than conventional 12-lead ECG
In summary, there is evidence that CGM is more efficacious than 12-lead ECG at the diagnosis of both stable CAD and ACS. The hope is this that the clinical application can be extended to localising ischaemia in the culprit vessel and be a valuable diagnostic aid.
The primary objective of this study is to investigate the efficacy of CGM to identify the culprit vessel in patients presenting with NSTEMI. Secondary endpoint will be to evaluate the efficacy of CGM to detect a significant coronary stenosis (defined as ≥70%) as compared to a standard 12-lead ECG
- Conditions
- Acute Coronary Syndrome
- Being tested
- Cardiogoniometry, 12-lead ECG
- Keywords
- Cardiogoniometry, Electrocardiography
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardiogoniometryDevice
Cardiogoniometry cardiologic explorer, Enverdis GmbH medical solutions, Germany
12-lead ECGDevice
| Study group | Role | What they receive |
|---|---|---|
| Cardiogoniometry | Experimental | Every patient in the study will have a cardiogoniometry recording performed by the Cardiologic Explorer whilst an inpatient on the ward. This will then be taken for interpretation to see if it indicates what vessel is the culprit causing their NSTEMI. The researcher interpreting the cardiogoniometry recording will be blind to the results of the ECG and the coronary angiography, Receives: Device: Cardiogoniometry |
| 12-lead ECG | Active comparator | For every patient in the study, copies of their 12-lead ECGs performed during their admission will be taken for interpretation by an independent cardiologist. This will then be taken for interpretation to see if it indicates what vessel is the culprit causing their NSTEMI.The researcher interpreting the ECG recordings will be blind to the results of the cardiogoniometry and the coronary angiography, Receives: Device: 12-lead ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of CGM
The sensitivity of CGM to detect the culprit vessel will be calculated.
Measured: Calculated within 30 days after participant recruitment is complete.
Specificity of CGM
The specificity of CGM to detect the culprit vessel will be calculated.
Measured: Calculated within 30 days after participant recruitment is complete.
Positive predictive value of CGM
The positive predictive value of CGM to detect the culprit vessel will be calculated.
Measured: Calculated within 30 days after participant recruitment is complete.
Negative predicative value of CGM
The negative predictive value of CGM to detect the culprit vessel will be calculated.
Measured: Calculated within 30 days after participant recruitment is complete.
Secondary outcomes (4)
Sensitivity of ECG
The sensitivity of CGM to detect the culprit vessel will be calculated.
Measured: Calculated within 30 days after participant recruitment is complete.
Specificity of ECG
The specificity of ECG to detect the culprit vessel will be calculated.
Measured: Calculated within 30 days after participant recruitment is complete.
Positive predictive value of ECG
The positive predictive value of ECG to detect the culprit vessel will be calculated.
Measured: Calculated within 30 days after participant recruitment is complete.
Negative predictive value of ECG
The negative predictive value of ECG to detect the culprit vessel will be calculated.
Measured: Calculated within 30 days after participant recruitment is complete.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study start17 Sep 2015
- Primary completion6 Sep 2016
- Study completion6 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02803931
- Sponsor's protocol ID
- 15/YH/0270
- Acronym
- COGNITION
- Status last verified
- Jul 2019
- First submitted
- 18 Feb 2016
- Last updated
- 24 Jul 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Efficacy of CardiOGoniometry (CGM) to Localise the Culprit Vessel in Mixed Vessel Disease Non-ST elevatIon Myocardial infarcTION (NSTEMI)
- ClinicalTrials.gov ID
- NCT02803931
- Acronym / sponsor ID
- COGNITION / 15/YH/0270
- Conditions
- Acute Coronary Syndrome
- Keywords
- Cardiogoniometry, Electrocardiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Study start
- 17 Sep 2015 (actual)
- Primary completion
- 6 Sep 2016 (actual)
- Study completion
- 6 Sep 2016 (actual)
- First posted
- 17 Jun 2016 (estimated)
- 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 study aims to test the hypothesis that cardiogoniometry (CGM) is helpful to identify the site of the culprit vessel in patients with NSTEMI in comparison to 12-lead ECG.
NSTEMI constitutes a clinical syndrome subset of acute coronary syndrome which is most usually caused by atherosclerotic coronary artery disease. It is defined by "electrocardiographic (ECG) ST-segment depression or prominent T-wave inversion and/or positive biomarkers of necrosis (e.g., troponin) in the absence of ST-segment elevation and in an appropriate clinical setting (chest discomfort or angina equivalent)". The standard 12 lead ECG is not commonly sensitive at localising the site of the culprit lesion and even coronary angiography may not always be helpful as the majority of lesions will not have angiographically evident thrombus. Patients with an ACS may have multivessel disease and it is often not possible to identify the precise site of the culprit lesion. In patients with multivessel disease, interventionists will frequently target the most severe stenosis even though this is not necessarily the acute lesion.
CGM (Cardiogoniometry cardiologic explorer, Enverdis GmbH medical solutions, Germany) is a form of 3D vector electrocardiography which can provide quantitative analysis of myocardial depolarisation and repolarisation. It has CE mark and has been shown to be more sensitive and specific than standard 12-lead ECG at diagnosing stable coronary artery disease. Furthermore, recent work has shown CGM to be more sensitive at detecting patients with NSTEMI than conventional 12-lead ECG
In summary, there is evidence that CGM is more efficacious than 12-lead ECG at the diagnosis of both stable CAD and ACS. The hope is this that the clinical application can be extended to localising ischaemia in the culprit vessel and be a valuable diagnostic aid.
The primary objective of this study is to investigate the efficacy of CGM to identify the culprit vessel in patients presenting with NSTEMI. Secondary endpoint will be to evaluate the efficacy of CGM to detect a significant coronary stenosis (defined as ≥70%) as compared to a standard 12-lead ECG
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiogoniometry | Experimental | Device: CardiogoniometryEvery patient in the study will have a cardiogoniometry recording performed by the Cardiologic Explorer whilst an inpatient on the ward. This will then be taken for interpretation to see if it indicates what vessel is the culprit causing their NSTEMI. The researcher interpreting the cardiogoniometry recording will be blind to the results of the ECG and the coronary angiography, |
| 12-lead ECG | Active comparator | Device: 12-lead ECGFor every patient in the study, copies of their 12-lead ECGs performed during their admission will be taken for interpretation by an independent cardiologist. This will then be taken for interpretation to see if it indicates what vessel is the culprit causing their NSTEMI.The researcher interpreting the ECG recordings will be blind to the results of the cardiogoniometry and the coronary angiography, |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients admitted with NSTEMI.
- Patients who have been consented to undergo coronary angiography +/- PCI as part of their routine care by their clinician.
- Aged 18 or over.
- The patient has been informed of the nature of the study and has provided full written informed consent.
Key exclusion criteria (9 listed)
- Patients unable to give informed consent including those with communication difficulties due to poor English.
- Patients with on-going chest pain at rest despite medical therapy
- Patients with haemodynamic instability and / or cardiogenic shock (defined as a sustained blood pressure of <90mmHg +/- the need for inotropic support)
- Patients with STEMI
- Those unable to perform a good quality CGM: 1) Patients who are SOB at rest; 2) Patients with very frequent ectopic beat; 3) Patients in atrial fibrillation; 4) Patients with a heart rate >150 beats/min
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CardiogoniometryCardiogoniometry cardiologic explorer, Enverdis GmbH medical solutions, Germany | Device | Cardiogoniometry |
| 12-lead ECG | Device | 12-lead ECG |
Primary outcome
Sensitivity of CGM
Time frame: Calculated within 30 days after participant recruitment is complete.
The sensitivity of CGM to detect the culprit vessel will be calculated.
Specificity of CGM
Time frame: Calculated within 30 days after participant recruitment is complete.
The specificity of CGM to detect the culprit vessel will be calculated.
Positive predictive value of CGM
Time frame: Calculated within 30 days after participant recruitment is complete.
The positive predictive value of CGM to detect the culprit vessel will be calculated.
Negative predicative value of CGM
Time frame: Calculated within 30 days after participant recruitment is complete.
The negative predictive value of CGM to detect the culprit vessel will be calculated.
4 secondary outcomes
Sensitivity of ECG
Time frame: Calculated within 30 days after participant recruitment is complete.
Specificity of ECG
Time frame: Calculated within 30 days after participant recruitment is complete.
Positive predictive value of ECG
Time frame: Calculated within 30 days after participant recruitment is complete.
Negative predictive value of ECG
Time frame: Calculated within 30 days after participant recruitment is complete.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiogoniometry and 12-lead ECG in people with Acute Coronary Syndrome, run by Hull University Teaching Hospitals NHS Trust 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 24 Jul 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of CGM (time frame: Calculated within 30 days after participant recruitment is complete.). The study lists 4 primary outcomes in all. 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 24 Jul 2019.