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

NCT02815631 | Completed

• 1 other identifier: 15/YH/2071
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Coronary Artery Disease

Keywords

fractional flow reserve; cardiogoniometry

Outcome Measures

Primary Outcomes (4)

• 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

  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.

  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.

  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.

  Calculated within 30 days after participant recruitment is complete.

Study Arms (2)

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.

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.

Device: Fractional Flow Reserve (FFR)

Interventions

Cardiogoniometry (CGM) DEVICE

Cardiogoniometry (CGM)

Fractional Flow Reserve (FFR) DEVICE

Fractional flow reserve (FFR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead

Study Sites (1)

Castle Hill Hospital

Hull, East Yorkshire, HU16 5JQ, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 29651685 RESULT

Related Links

• Cardiogoniometry Compared to Fractional Flow Reserve at Identifying

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2016
• First Posted: June 28, 2016
• Study Start: September 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: October 1, 2016
• Last Updated: August 18, 2022

Record last verified: 2022-08

Locations

GB (1)