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Cardiogoniometry (CGM) for Early Diagnosis of Acute Coronary Syndromes (ACS) (CGM@ACS)

Primary Purpose

Chest Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cardiogoniometry
Sponsored by
Stiftung Institut fuer Herzinfarktforschung
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chest Pain focused on measuring Cardiogoniometry, Chest Pain Unit, ST-elevation, Troponin, Catheter intervention, Fast Track

Eligibility Criteria

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

Inclusion Criteria:

  • Age > 18 years
  • thoracic pain, or pain radiating to neck or arm, or acute dyspnoea
  • coronary angiography within 72 hours after start of symptoms

Exclusion Criteria:

  • ST elevation myocardial infarction
  • hemodynamically unstable patients, provided that the application of CGM may lead to an unacceptable delay in diagnosis and therapy
  • lack of blood samples for troponin determination at admission
  • patients with cardiac pacemaker
  • cardiogenic shock
  • tachycardia (HR > 100)
  • > 50% extra systoles
  • branch block
  • atrial fibrillation
  • no informed consent

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Difference between cardiogoniometry finding and leading diagnoses of chest pain unit, coronary angiography, and at discharge in assessing the origin of chest pain
    Aim is to examine if cardiogoniometry can provide additional information for the decision to perform a diagnostic coronary angiography and if so, which additional value it has. To assess the value of cardiogoniometry its results are compared with the leading diagnosis of the Chest Pain Unit, the diagnosis at hospital discharge as well as with the angiographic findings (as a gold standard).

    Secondary Outcome Measures

    Full Information

    First Posted
    February 11, 2011
    Last Updated
    April 1, 2011
    Sponsor
    Stiftung Institut fuer Herzinfarktforschung
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01328795
    Brief Title
    Cardiogoniometry (CGM) for Early Diagnosis of Acute Coronary Syndromes (ACS)
    Acronym
    CGM@ACS
    Official Title
    Cardiogoniometry Zur Früherkennung Akuter Myokardischämien Bei ACS-Symptomatik
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2009 (undefined)
    Primary Completion Date
    April 2010 (Actual)
    Study Completion Date
    May 2010 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Stiftung Institut fuer Herzinfarktforschung

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Aims of the study: Patients in a Chest Pain Unit (CPU) are examined to clarify if the cause of pain is cardiac or not. To identify patients with ST-elevation and other electrocardiogram (ECG) modifications a normal 12-lead ECG is used. The diagnosis non-st-elevation myocardial infarction is determined with the help of the ischemic marker Troponin. However, Troponin levels are elevated earliest 3 to 4 hours after the ischemic event, so that a negative Troponin result at the time of hospital admission is insufficient. Thus the guidelines of the German Society of Cardiology demand a second measurement after 6 to 12 hours. In rare cases false positive Troponin levels have been reported (e.g. in patients with renal insufficiency). The aim of this study is to determine if in the early phase of diagnostic assessment cardiogoniometry can improve differentiation between patients with cardiac (ischemic) emergency and patients with non-cardiac (non-ischemic) cause of pain. Furthermore it will be evaluated if cardiogoniometry is capable to diagnose patients with non-ST-elevation myocardial infarction (NSTEMI) to the same extent as Troponin. This could avoid time loss until a possibly necessary catheter intervention ("fast track"). To clarify these questions the result of the cardiogoniometry will be compared with the leading diagnosis of the Chest Pain Unit, the diagnosis at hospital discharge as well as with the angiographic findings (as a gold standard). Therefore the performance of cardiac catheterization within 72 hours after start of symptoms is a mandatory inclusion criterion.
    Detailed Description
    The cardiogoniometry vectorcardiography is a procedure that allows a stress-free and non-invasive diagnosis of myocardial ischemia: five thoracic electrodes as well as the heart flow in orthogonal summation vectors are recorded by a computer-assisted method in three dimensions.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chest Pain
    Keywords
    Cardiogoniometry, Chest Pain Unit, ST-elevation, Troponin, Catheter intervention, Fast Track

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    249 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Other
    Intervention Name(s)
    cardiogoniometry
    Intervention Description
    In the course of the project a cardiogoniometry will be carried out during the ambulant or residential hospitalization before the coronary angiography.
    Primary Outcome Measure Information:
    Title
    Difference between cardiogoniometry finding and leading diagnoses of chest pain unit, coronary angiography, and at discharge in assessing the origin of chest pain
    Description
    Aim is to examine if cardiogoniometry can provide additional information for the decision to perform a diagnostic coronary angiography and if so, which additional value it has. To assess the value of cardiogoniometry its results are compared with the leading diagnosis of the Chest Pain Unit, the diagnosis at hospital discharge as well as with the angiographic findings (as a gold standard).
    Time Frame
    72 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age > 18 years thoracic pain, or pain radiating to neck or arm, or acute dyspnoea coronary angiography within 72 hours after start of symptoms Exclusion Criteria: ST elevation myocardial infarction hemodynamically unstable patients, provided that the application of CGM may lead to an unacceptable delay in diagnosis and therapy lack of blood samples for troponin determination at admission patients with cardiac pacemaker cardiogenic shock tachycardia (HR > 100) > 50% extra systoles branch block atrial fibrillation no informed consent
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jochen Senges, MD
    Organizational Affiliation
    Stiftung Institut fuer Herzinfarktfoschung
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Cardiogoniometry (CGM) for Early Diagnosis of Acute Coronary Syndromes (ACS)

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