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 (CARDIOFLOW)
Coronary Artery Disease
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring fractional flow reserve, cardiogoniometry
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Castle Hill Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Cardiogoniometry (CGM)
Fractional flow reserve (FFR)
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. First baseline recording - taken when the patient first enters the catheterisation laboratory and is prepped for their procedure. Second baseline recording - taken when the FFR guide wire is in place in the coronary artery being assessed. 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.
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: A baseline FFR will be recorded once the pressure wire has been advanced down the coronary artery being assessed. Maximal hyperaemia FFR will be recorded during adenosine infusion. An FFR ratio of <0.80 will be regarded as a positive result.