Ignite Creation Date:
2024-05-06 @ 8:43 AM
Last Modification Date:
2024-10-26 @ 12:04 PM
Study NCT ID:
NCT02803931
Status:
COMPLETED
Last Update Posted:
2019-07-24
First Post:
2016-02-18
Brief Title:
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
Organization:
Hull University Teaching Hospitals NHS Trust
Study Overview
Official Title:
Assessing the Efficacy of CardiOGoniometry CGM to Localise the Culprit Vessel in Mixed Vessel Disease Non-ST elevatIon Myocardial infarcTION NSTEMI
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COGNITION
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 andor positive biomarkers of necrosis eg 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
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 andor positive biomarkers of necrosis eg 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None