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
  Purpose

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 Intervention
Chest Pain
Other: cardiogoniometry

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Cardiogoniometry Zur Früherkennung Akuter Myokardischämien Bei ACS-Symptomatik

Resource links provided by NLM:


Further study details as provided by Stiftung Institut fuer Herzinfarktforschung:

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 [ 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).


Enrollment: 249
Study Start Date: June 2009
Study Completion Date: May 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01328795

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

No publications provided

Responsible Party: Prof. Jochen Senges, Institut für Herzinfarktforschung Ludwigshafen an der Universität Heidelberg
ClinicalTrials.gov Identifier: NCT01328795     History of Changes
Other Study ID Numbers: CGM@ACS
Study First Received: February 11, 2011
Last Updated: April 1, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Stiftung Institut fuer Herzinfarktforschung:
Cardiogoniometry
Chest Pain Unit
ST-elevation
Troponin
Catheter intervention
Fast Track

Additional relevant MeSH terms:
Chest Pain
Acute Coronary Syndrome
Pain
Signs and Symptoms
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases

ClinicalTrials.gov processed this record on July 26, 2014