Acute Coronary Syndrome Clinical Trial
Official title:
Assessing the Efficacy of CardiOGoniometry (CGM) to Localise the Culprit Vessel in Mixed Vessel Disease Non-ST elevatIon Myocardial infarcTION (NSTEMI)
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
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