Coronary Artery DiseaseCARDIOFLOWNCT02815631
Assessing the Efficacy of CARDIOgoniometry (CGM) to Determine Physiologically Significant Stenosis in Patients With Stable Coronary Artery Disease in Comparison to Fractional FLOW Reserve - CARDIOFLOW
A study testing Cardiogoniometry (CGM) and Fractional Flow Reserve (FFR) in people with Coronary Artery Disease, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
The CARDIOFLOW study compares the standard test, a pressure wire test called fractional flow reserve (FFR), with a new method that is based on taking a detailed "3D" ECG called Cardiogoniometry (CGM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Cardiogoniometry (CGM) and Fractional Flow Reserve (FFR)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2015to 1 Oct 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 stable coronary artery disease for elective percutaneous coronary intervention (PCI)
- 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.
- FFR will be performed on study participants who demonstrate visible coronary stenosis on coronary angiography.
Who cannot join
- Patients unable to give informed consent including those with communication difficulties due to poor English.
- Patients with haemodynamic instability and / or cardiogenic shock (defined as a sustained blood pressure of <90mmHg +/- the need for inotropic support)
- Patients with an acute coronary syndrome (as defined by the European Society of Cardiology)
- Those unable to perform a good quality CGM: 1) Patients who are SOB at rest; 2) Patients with very frequent ectopic beats; 3) Patients in atrial fibrillation; 4) Patients with a heart rate >150 beats/min
- Those patients unable to tolerate adenosine: 1) Patients with severe asthma, especially if taking oral theophylline; 2) Patients with second or third degree heart block (without a pacemaker in situ); 3) Patients with sick sinus syndrome; 4) Patients with Long QT syndrome; 5)Patients with severe hypotension (systolic pressure) <100mmHg); 6) Patients with decompensated heart failure.
- Patients with previous coronary artery bypass graft surgery
Show all 12Show fewer
- Patients who are unable to receive treatment with heparin
- Patients with a chronic total occlusion
- Patients with extremely tortuous or calcified vessels that are unfavourable for assessment with FFR.
- Patients with severe stenosis of the left main stem
- 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
The CARDIOFLOW study compares the standard test, a pressure wire test called fractional flow reserve (FFR), with a new method that is based on taking a detailed "3D" ECG called Cardiogoniometry (CGM).
FFR is an angiographic technique which measures the physiological significance of a coronary stenosis and trial data has shown that basing management decisions on this data improves prognosis. However FFR studies are expensive and invasive, whereas CGM is painless and simply involves placing 4 sticky pads to the patient's chest / back and is similar to an ECG (heart tracing). The investigators want to see whether we can use this new method to find out whether treatment with coronary angioplasty would be of benefit. If so, then in the future, clinicians could use this method (CGM) rather than pressure wire assessment (FFR). This would have several advantages; in particular, it can be easily performed in the clinic and avoids the need to use an expensive pressure wire.
Read the detailed description
This study aims to test the hypothesis that cardiogoniometry (CGM) is helpful to identify physiologically significant coronary artery stenosis in comparison to fractional flow reserve (FFR).
Last year in the UK 202 098 patients underwent coronary angiography to determine whether they had significant coronary artery disease. However, it is well recognised that, even with orthogonal views, angiography is limited in terms of its ability to determine the functional importance of coronary lesions. In particular those lesions judged to be 50-70% stenosed may not necessarily cause ischaemia as this depends on factors such as the lesion length and, importantly, the size of the territory supplied by the vessel.
There have been several studies that have demonstrated the clinical utility of evaluating such lesions with FFR. The measurement of FFR is an index of the physiological significance of a coronary stenosis and is defined as the ratio of maximal blood flow in a stenotic artery to normal maximal flow. It is calculated by comparing the ratio of the aortic pressure and the pressure distal to the coronary stenosis during maximal hyperaemia. These pressures are measured by introducing a coronary pressure guide wire into the artery and hyperaemia is induced by giving an infusion of adenosine intravenously. An FFR ratio of <0.80 indicates that the coronary stenosis is causing significant ischaemia and would benefit from PCI. This has since been incorporated into ESC clinical guidelines on myocardial revascularisation.
However this is an invasive procedure and the pressure wires are relatively expensive compared to standard angioplasty wires. On the contrary, CGM is a cheap and non-invasive technique that can be easily applied. The aim of the proposed study is to assess whether CGM may be able to aid clinicians in identifying if a coronary stenosis is physiologically significant at inducing myocardial ischaemia in conjunction with standard coronary angiography.
CGM is form of 3D vector electrocardiography which can provide quantitative analysis of myocardial depolarisation and repolarisation. It has been shown to be more sensitive and specific than standard 12-lead ECG at diagnosing stable coronary artery disease. Furthermore, other work has showed CGM to be more sensitive than 12-lead ECG at detecting patients with ACS. More recently in 2012, further work found that CGM was more sensitive and specific than the 12 lead ECG at identifying abnormal myocardial perfusion scans (MPS). FFR validity was initially based on a comparison with MPS and therefore we hypothesise that CGM may be comparable to FFR.
- Conditions
- Coronary Artery Disease
- Being tested
- Cardiogoniometry (CGM), Fractional Flow Reserve (FFR)
- Keywords
- fractional flow reserve, cardiogoniometry
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiogoniometry (CGM)Device
Fractional Flow Reserve (FFR)Device
| Study group | Role | What they receive |
|---|---|---|
| Cardiogoniometry (CGM) | Experimental | Every patient involved in the study will undergo a series of CGM recordings whilst having their FFR procedure. These recordings will all be done whilst they are in the catheterisation laboratory and will be taking at the following points during the procedure.
1. First baseline recording - taken when the patient first enters the catheterisation laboratory and is prepped for their procedure.
2. Second baseline recording - taken when the FFR guide wire is in place in the coronary artery being assessed.
3. Maximal hyperaemia recording - this will be taken when the patient is at maximal hyperaemia during their adenosine infusion for their FFR procedure.
The patients involvement will then be finished in the study and will be cared for as per clinical practice.
If the CGM records a result of anything less than 0, it will be regarded as a positive result. Receives: Device: Cardiogoniometry (CGM) |
| Fractional flow reserve (FFR) | Active comparator | Every patient involved in the study will undergo an FFR assessment of their coronary arteries. These recordings will all be done whilst they are in the catheterisation laboratory. They will have the following recordings:
1. A baseline FFR will be recorded once the pressure wire has been advanced down the coronary artery being assessed.
2. Maximal hyperaemia FFR will be recorded during adenosine infusion.
An FFR ratio of <0.80 will be regarded as a positive result. Receives: Device: Fractional Flow Reserve (FFR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of CGM to detect physiologically important coronary stenosis.
The sensitivity of CGM to detect physiologically important coronary stenosis will be calculated after all participants are recruited. The number of patients which had true positive results (that is CGM tested positive when they had significant coronary disease) will be divided by the total number of participants who were found to have physiologically important coronary stenosis and expressed as a percentage
Measured: Calculated within 30 days after participant recruitment is complete.
Specificity of CGM to detect physiologically important coronary stenosis
The specificity of CGM to detect physiologically important coronary stenosis will be calculated after all participants are recruited. The number of patients which had true negative results (that is CGM tested negative when they did not have significant coronary disease) will be divided by the total number of participants who were found not to have physiologically important coronary stenosis and expressed as a percentage.
Measured: Calculated within 30 days after participant recruitment is complete.
Positive predictive value (PPV) of CGM to detect physiologically important coronary stenosis
The PPV of CGM to detect physiologically important coronary stenosis will be calculated after all participants are recruited. The number of patients which had true positive results (that is CGM tested positive when they had significant coronary disease) will be divided by the total number of participants who had a positive CGM test and expressed as a percentage.
Measured: Calculated within 30 days after participant recruitment is complete.
Negative predictive value (NPV) of CGM to detect physiologically important coronary stenosis
The NPV of CGM to detect physiologically important coronary stenosis will be calculated after all participants are recruited. The number of patients which had true negative CGM result (that is CGM tested negative when they didn't not have significant coronary disease) will be divided by the total number of participants who had a negative CGM result and expressed as a percentage.
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 posted28 Jun 2016 (estimated)
- Study startSep 2015
- Primary completionSep 2016
- Study completion1 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Triple blind
- Who is masked
- Care provider, 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
- NCT02815631
- Sponsor's protocol ID
- 15/YH/2071
- Acronym
- CARDIOFLOW
- Status last verified
- Aug 2022
- First submitted
- 18 Feb 2016
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Brown OI, Clark AL, Chelliah R, Davison BJ, Mather AN, Cunnington MS, John J, Alahmar A, Oliver R, Aznaouridis K, Hoye A. Cardiogoniometry Compared to Fractional Flow Reserve at Identifying Physiologically Significant Coronary Stenosis: The CARDIOFLOW Study. Cardiovasc Eng Technol. 2018 Sep;9(3):439-446. doi: 10.1007/s13239-018-0354-1. Epub 2018 Apr 12.
PubMed 29651685
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Efficacy of CARDIOgoniometry (CGM) to Determine Physiologically Significant Stenosis in Patients With Stable Coronary Artery Disease in Comparison to Fractional FLOW Reserve - CARDIOFLOW
- ClinicalTrials.gov ID
- NCT02815631
- Acronym / sponsor ID
- CARDIOFLOW / 15/YH/2071
- Conditions
- Coronary Artery Disease
- Keywords
- fractional flow reserve, cardiogoniometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Study start
- Sep 2015 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- 1 Oct 2016 (actual)
- First posted
- 28 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.
The CARDIOFLOW study compares the standard test, a pressure wire test called fractional flow reserve (FFR), with a new method that is based on taking a detailed "3D" ECG called Cardiogoniometry (CGM).
FFR is an angiographic technique which measures the physiological significance of a coronary stenosis and trial data has shown that basing management decisions on this data improves prognosis. However FFR studies are expensive and invasive, whereas CGM is painless and simply involves placing 4 sticky pads to the patient's chest / back and is similar to an ECG (heart tracing). The investigators want to see whether we can use this new method to find out whether treatment with coronary angioplasty would be of benefit. If so, then in the future, clinicians could use this method (CGM) rather than pressure wire assessment (FFR). This would have several advantages; in particular, it can be easily performed in the clinic and avoids the need to use an expensive pressure wire.
Detailed description
This study aims to test the hypothesis that cardiogoniometry (CGM) is helpful to identify physiologically significant coronary artery stenosis in comparison to fractional flow reserve (FFR).
Last year in the UK 202 098 patients underwent coronary angiography to determine whether they had significant coronary artery disease. However, it is well recognised that, even with orthogonal views, angiography is limited in terms of its ability to determine the functional importance of coronary lesions. In particular those lesions judged to be 50-70% stenosed may not necessarily cause ischaemia as this depends on factors such as the lesion length and, importantly, the size of the territory supplied by the vessel.
There have been several studies that have demonstrated the clinical utility of evaluating such lesions with FFR. The measurement of FFR is an index of the physiological significance of a coronary stenosis and is defined as the ratio of maximal blood flow in a stenotic artery to normal maximal flow. It is calculated by comparing the ratio of the aortic pressure and the pressure distal to the coronary stenosis during maximal hyperaemia. These pressures are measured by introducing a coronary pressure guide wire into the artery and hyperaemia is induced by giving an infusion of adenosine intravenously. An FFR ratio of <0.80 indicates that the coronary stenosis is causing significant ischaemia and would benefit from PCI. This has since been incorporated into ESC clinical guidelines on myocardial revascularisation.
However this is an invasive procedure and the pressure wires are relatively expensive compared to standard angioplasty wires. On the contrary, CGM is a cheap and non-invasive technique that can be easily applied. The aim of the proposed study is to assess whether CGM may be able to aid clinicians in identifying if a coronary stenosis is physiologically significant at inducing myocardial ischaemia in conjunction with standard coronary angiography.
CGM is form of 3D vector electrocardiography which can provide quantitative analysis of myocardial depolarisation and repolarisation. It has been shown to be more sensitive and specific than standard 12-lead ECG at diagnosing stable coronary artery disease. Furthermore, other work has showed CGM to be more sensitive than 12-lead ECG at detecting patients with ACS. More recently in 2012, further work found that CGM was more sensitive and specific than the 12 lead ECG at identifying abnormal myocardial perfusion scans (MPS). FFR validity was initially based on a comparison with MPS and therefore we hypothesise that CGM may be comparable to FFR.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiogoniometry (CGM) | Experimental | Device: Cardiogoniometry (CGM)Every patient involved in the study will undergo a series of CGM recordings whilst having their FFR procedure. These recordings will all be done whilst they are in the catheterisation laboratory and will be taking at the following points during the procedure. 1. First baseline recording - taken when the patient first enters the catheterisation laboratory and is prepped for their procedure. 2. Second baseline recording - taken when the FFR guide wire is in place in the coronary artery being assessed. 3. Maximal hyperaemia recording - this will be taken when the patient is at maximal hyperaemia during their adenosine infusion for their FFR procedure. The patients involvement will then be finished in the study and will be cared for as per clinical practice. If the CGM records a result of anything less than 0, it will be regarded as a positive result. |
| Fractional flow reserve (FFR) | Active comparator | Device: Fractional Flow Reserve (FFR)Every patient involved in the study will undergo an FFR assessment of their coronary arteries. These recordings will all be done whilst they are in the catheterisation laboratory. They will have the following recordings: 1. A baseline FFR will be recorded once the pressure wire has been advanced down the coronary artery being assessed. 2. Maximal hyperaemia FFR will be recorded during adenosine infusion. An FFR ratio of <0.80 will be regarded as a positive result. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients admitted with stable coronary artery disease for elective percutaneous coronary intervention (PCI)
- 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.
- FFR will be performed on study participants who demonstrate visible coronary stenosis on coronary angiography.
Key exclusion criteria (12 listed)
- Patients unable to give informed consent including those with communication difficulties due to poor English.
- Patients with haemodynamic instability and / or cardiogenic shock (defined as a sustained blood pressure of <90mmHg +/- the need for inotropic support)
- Patients with an acute coronary syndrome (as defined by the European Society of Cardiology)
- Those unable to perform a good quality CGM: 1) Patients who are SOB at rest; 2) Patients with very frequent ectopic beats; 3) Patients in atrial fibrillation; 4) Patients with a heart rate >150 beats/min
- Those patients unable to tolerate adenosine: 1) Patients with severe asthma, especially if taking oral theophylline; 2) Patients with second or third degree heart block (without a pacemaker in situ); 3) Patients with sick sinus syndrome; 4) Patients with Long QT syndrome; 5)Patients with severe hypotension (systolic pressure) <100mmHg); 6) Patients with decompensated heart failure.
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 |
|---|---|---|
| Cardiogoniometry (CGM) | Device | Cardiogoniometry (CGM) |
| Fractional Flow Reserve (FFR) | Device | Fractional flow reserve (FFR) |
Primary outcome
Sensitivity of CGM to detect physiologically important coronary stenosis.
Time frame: Calculated within 30 days after participant recruitment is complete.
The sensitivity of CGM to detect physiologically important coronary stenosis will be calculated after all participants are recruited. The number of patients which had true positive results (that is CGM tested positive when they had significant coronary disease) will be divided by the total number of participants who were found to have physiologically important coronary stenosis and expressed as a percentage
Specificity of CGM to detect physiologically important coronary stenosis
Time frame: Calculated within 30 days after participant recruitment is complete.
The specificity of CGM to detect physiologically important coronary stenosis will be calculated after all participants are recruited. The number of patients which had true negative results (that is CGM tested negative when they did not have significant coronary disease) will be divided by the total number of participants who were found not to have physiologically important coronary stenosis and expressed as a percentage.
Positive predictive value (PPV) of CGM to detect physiologically important coronary stenosis
Time frame: Calculated within 30 days after participant recruitment is complete.
The PPV of CGM to detect physiologically important coronary stenosis will be calculated after all participants are recruited. The number of patients which had true positive results (that is CGM tested positive when they had significant coronary disease) will be divided by the total number of participants who had a positive CGM test and expressed as a percentage.
Negative predictive value (NPV) of CGM to detect physiologically important coronary stenosis
Time frame: Calculated within 30 days after participant recruitment is complete.
The NPV of CGM to detect physiologically important coronary stenosis will be calculated after all participants are recruited. The number of patients which had true negative CGM result (that is CGM tested negative when they didn't not have significant coronary disease) will be divided by the total number of participants who had a negative CGM result and expressed as a percentage.
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 18 Aug 2022.
- Results publication: PubMed 29651685Brown OI, Clark AL, Chelliah R, Davison BJ, Mather AN, Cunnington MS, John J, Alahmar A, Oliver R, Aznaouridis K, Hoye A. Cardiogoniometry Compared to Fractional Flow Reserve at Identifying Physiologically Significant Coronary Stenosis: The CARDIOFLOW Study. Cardiovasc Eng Technol. 2018 Sep;9(3):439-446. doi: 10.1007/s13239-018-0354-1. Epub 2018 Apr 12.
- Cardiogoniometry Compared to Fractional Flow Reserve at IdentifyingLink provided by the sponsor.
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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 (CGM) and Fractional Flow Reserve (FFR) in people with Coronary Artery Disease, 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 5 inclusion and 12 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 18 Aug 2022. 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 to detect physiologically important coronary stenosis. (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?
On the ClinicalTrials.gov record for NCT02815631, which also lists 1 linked publication.
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 18 Aug 2022.