search
Back to results

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

Primary Purpose

Acute Coronary Syndrome

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Cardiogoniometry
12-lead ECG
Sponsored by
Hull University Teaching Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Coronary Syndrome focused on measuring Cardiogoniometry, Electrocardiography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Castle Hill Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cardiogoniometry

12-lead ECG

Arm Description

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,

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,

Outcomes

Primary Outcome Measures

Sensitivity of CGM
The sensitivity of CGM to detect the culprit vessel will be calculated.
Specificity of CGM
The specificity of CGM to detect the culprit vessel will be calculated.
Positive predictive value of CGM
The positive predictive value of CGM to detect the culprit vessel will be calculated.
Negative predicative value of CGM
The negative predictive value of CGM to detect the culprit vessel will be calculated.

Secondary Outcome Measures

Sensitivity of ECG
The sensitivity of CGM to detect the culprit vessel will be calculated.
Specificity of ECG
The specificity of ECG to detect the culprit vessel will be calculated.
Positive predictive value of ECG
The positive predictive value of ECG to detect the culprit vessel will be calculated.
Negative predictive value of ECG
The negative predictive value of ECG to detect the culprit vessel will be calculated.

Full Information

First Posted
February 18, 2016
Last Updated
July 22, 2019
Sponsor
Hull University Teaching Hospitals NHS Trust
search

1. Study Identification

Unique Protocol Identification Number
NCT02803931
Brief Title
Assessing the Efficacy of CardiOGoniometry (CGM) to Localise the Culprit Vessel in Mixed Vessel Disease Non-ST elevatIon Myocardial infarcTION (NSTEMI)
Acronym
COGNITION
Official Title
Assessing the Efficacy of CardiOGoniometry (CGM) to Localise the Culprit Vessel in Mixed Vessel Disease Non-ST elevatIon Myocardial infarcTION (NSTEMI)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 17, 2015 (Actual)
Primary Completion Date
September 6, 2016 (Actual)
Study Completion Date
September 6, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hull University Teaching Hospitals NHS Trust

4. Oversight

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
Cardiogoniometry, Electrocardiography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cardiogoniometry
Arm Type
Experimental
Arm Description
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,
Arm Title
12-lead ECG
Arm Type
Active Comparator
Arm Description
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,
Intervention Type
Device
Intervention Name(s)
Cardiogoniometry
Intervention Description
Cardiogoniometry cardiologic explorer, Enverdis GmbH medical solutions, Germany
Intervention Type
Device
Intervention Name(s)
12-lead ECG
Primary Outcome Measure Information:
Title
Sensitivity of CGM
Description
The sensitivity of CGM to detect the culprit vessel will be calculated.
Time Frame
Calculated within 30 days after participant recruitment is complete.
Title
Specificity of CGM
Description
The specificity of CGM to detect the culprit vessel will be calculated.
Time Frame
Calculated within 30 days after participant recruitment is complete.
Title
Positive predictive value of CGM
Description
The positive predictive value of CGM to detect the culprit vessel will be calculated.
Time Frame
Calculated within 30 days after participant recruitment is complete.
Title
Negative predicative value of CGM
Description
The negative predictive value of CGM to detect the culprit vessel will be calculated.
Time Frame
Calculated within 30 days after participant recruitment is complete.
Secondary Outcome Measure Information:
Title
Sensitivity of ECG
Description
The sensitivity of CGM to detect the culprit vessel will be calculated.
Time Frame
Calculated within 30 days after participant recruitment is complete.
Title
Specificity of ECG
Description
The specificity of ECG to detect the culprit vessel will be calculated.
Time Frame
Calculated within 30 days after participant recruitment is complete.
Title
Positive predictive value of ECG
Description
The positive predictive value of ECG to detect the culprit vessel will be calculated.
Time Frame
Calculated within 30 days after participant recruitment is complete.
Title
Negative predictive value of ECG
Description
The negative predictive value of ECG to detect the culprit vessel will be calculated.
Time Frame
Calculated within 30 days after participant recruitment is complete.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Castle Hill Hospital
City
Kingston upon Hull
State/Province
East Yorkshire
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs