COGNITION: Assessing the Efficacy of CardiOGoniometry (CGM) to Localise the Culprit Vessel in Mixed Vessel Disease Non-ST elevatIon Myocardial infarcTION (NSTEMI)

Sponsor

Hull University Teaching Hospitals NHS Trust (Other)

Overall Status

Completed

CT.gov ID

NCT02803931

Collaborator

(none)

Enrollment

Location

Arms

11.7

Actual Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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 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

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome	Device: Cardiogoniometry Device: 12-lead ECG	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

Assessing the Efficacy of CardiOGoniometry (CGM) to Localise the Culprit Vessel in Mixed Vessel Disease Non-ST elevatIon Myocardial infarcTION (NSTEMI)

Actual Study Start Date :

Sep 17, 2015

Actual Primary Completion Date :

Sep 6, 2016

Actual Study Completion Date :

Sep 6, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cardiogoniometry 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,	Device: Cardiogoniometry Cardiogoniometry cardiologic explorer, Enverdis GmbH medical solutions, Germany
Active Comparator: 12-lead ECG 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,	Device: 12-lead ECG

Arm

Intervention/Treatment

Experimental: Cardiogoniometry

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,

Device: Cardiogoniometry

Cardiogoniometry cardiologic explorer, Enverdis GmbH medical solutions, Germany

Active Comparator: 12-lead ECG

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,

Device: 12-lead ECG

Outcome Measures

Primary Outcome Measures

Sensitivity of CGM [Calculated within 30 days after participant recruitment is complete.]
The sensitivity of CGM to detect the culprit vessel will be calculated.
Specificity of CGM [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 [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 [Calculated within 30 days after participant recruitment is complete.]
The negative predictive value of CGM to detect the culprit vessel will be calculated.

Secondary Outcome Measures

Sensitivity of ECG [Calculated within 30 days after participant recruitment is complete.]
The sensitivity of CGM to detect the culprit vessel will be calculated.
Specificity of ECG [Calculated within 30 days after participant recruitment is complete.]
The specificity of ECG to detect the culprit vessel will be calculated.
Positive predictive value of ECG [Calculated within 30 days after participant recruitment is complete.]
The positive predictive value of ECG to detect the culprit vessel will be calculated.
Negative predictive value of ECG [Calculated within 30 days after participant recruitment is complete.]
The negative predictive value of ECG to detect the culprit vessel will be calculated.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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
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