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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01328795
Recruitment Status : Completed
First Posted : April 5, 2011
Last Update Posted : April 5, 2011
Information provided by:
Stiftung Institut fuer Herzinfarktforschung

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.

Condition or disease Intervention/treatment Phase
Chest Pain Other: cardiogoniometry Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 249 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Cardiogoniometry Zur Früherkennung Akuter Myokardischämien Bei ACS-Symptomatik
Study Start Date : June 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chest Pain
U.S. FDA Resources

Intervention Details:
    Other: cardiogoniometry
    In the course of the project a cardiogoniometry will be carried out during the ambulant or residential hospitalization before the coronary angiography.

Primary Outcome Measures :
  1. Difference between cardiogoniometry finding and leading diagnoses of chest pain unit, coronary angiography, and at discharge in assessing the origin of chest pain [ Time Frame: 72 hours ]
    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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01328795

Sponsors and Collaborators
Stiftung Institut fuer Herzinfarktforschung
Study Director: Jochen Senges, MD Stiftung Institut fuer Herzinfarktfoschung

Responsible Party: Prof. Jochen Senges, Institut für Herzinfarktforschung Ludwigshafen an der Universität Heidelberg Identifier: NCT01328795     History of Changes
Other Study ID Numbers: CGM@ACS
First Posted: April 5, 2011    Key Record Dates
Last Update Posted: April 5, 2011
Last Verified: April 2011

Keywords provided by Stiftung Institut fuer Herzinfarktforschung:
Chest Pain Unit
Catheter intervention
Fast Track

Additional relevant MeSH terms:
Chest Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms