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

This study has been completed.
Sponsor:
Information provided by:
Stiftung Institut fuer Herzinfarktforschung
ClinicalTrials.gov Identifier:
NCT01328795
First received: February 11, 2011
Last updated: April 1, 2011
Last verified: April 2011

February 11, 2011
April 1, 2011
June 2009
April 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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).
Same as current
Complete list of historical versions of study NCT01328795 on ClinicalTrials.gov Archive Site
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Cardiogoniometry (CGM) for Early Diagnosis of Acute Coronary Syndromes (ACS)
Cardiogoniometry Zur Früherkennung Akuter Myokardischämien Bei ACS-Symptomatik

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.

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.

Interventional
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Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Chest Pain
Other: cardiogoniometry
In the course of the project a cardiogoniometry will be carried out during the ambulant or residential hospitalization before the coronary angiography.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
249
May 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01328795
CGM@ACS
No
Prof. Jochen Senges, Institut für Herzinfarktforschung Ludwigshafen an der Universität Heidelberg
Stiftung Institut fuer Herzinfarktforschung
Not Provided
Study Director: Jochen Senges, MD Stiftung Institut fuer Herzinfarktfoschung
Stiftung Institut fuer Herzinfarktforschung
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP