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

Sponsor

Stiftung Institut fuer Herzinfarktforschung (Other)

Overall Status

Completed

CT.gov ID

NCT01328795

Collaborator

(none)

249

Enrollment

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chest Pain	Other: cardiogoniometry	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

249 participants

Allocation:

N/A

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 :

Jun 1, 2009

Actual Primary Completion Date :

Apr 1, 2010

Actual Study Completion Date :

May 1, 2010

Outcome Measures

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 [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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