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Completed

NCT Number: NCT02803931

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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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Castle Hill Hospital

Hull, East Yorkshire, HU16 5JQ, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiogoniometry

Device

Cardiogoniometry cardiologic explorer, Enverdis GmbH medical solutions, Germany

12-lead ECG

Device

Primary outcomes

  1. Sensitivity of CGM

    Time frame: Calculated within 30 days after participant recruitment is complete.

    The sensitivity of CGM to detect the culprit vessel will be calculated.

  2. Specificity of CGM

    Time frame: Calculated within 30 days after participant recruitment is complete.

    The specificity of CGM to detect the culprit vessel will be calculated.

  3. Positive predictive value of CGM

    Time frame: Calculated within 30 days after participant recruitment is complete.

    The positive predictive value of CGM to detect the culprit vessel will be calculated.

  4. Negative predicative value of CGM

    Time frame: Calculated within 30 days after participant recruitment is complete.

    The negative predictive value of CGM to detect the culprit vessel will be calculated.

Secondary outcomes

  1. Sensitivity of ECG

    Time frame: Calculated within 30 days after participant recruitment is complete.

    The sensitivity of CGM to detect the culprit vessel will be calculated.

  2. Specificity of ECG

    Time frame: Calculated within 30 days after participant recruitment is complete.

    The specificity of ECG to detect the culprit vessel will be calculated.

  3. Positive predictive value of ECG

    Time frame: Calculated within 30 days after participant recruitment is complete.

    The positive predictive value of ECG to detect the culprit vessel will be calculated.

  4. Negative predictive value of ECG

    Time frame: Calculated within 30 days after participant recruitment is complete.

    The negative predictive value of ECG to detect the culprit vessel will be calculated.

Sponsors and collaborators

Lead sponsor

Hull University Teaching Hospitals NHS Trust

Other Gov

Registry information

Acronym: COGNITION

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 17, 2016
Registry last updated
Jul 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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