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

Chest Pain Clinical Trial

— CGM@ACS  

Official title:

Cardiogoniometry Zur Früherkennung Akuter Myokardischämien Bei ACS-Symptomatik

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01328795
• Other study ID #: CGM@ACS
• Status: Completed
• Phase: N/A
• First received: February 11, 2011
• Last updated: April 1, 2011
• Start date: June 2009
• Est. completion date: May 2010

Study information

• Verified date: April 2011
• Source: Stiftung Institut fuer Herzinfarktforschung
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 249
• Est. completion date: May 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Chest Pain

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stiftung Institut fuer Herzinfarktforschung

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	72 hours	No