NCT01328795

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

Cardiogoniometry Zur Früherkennung Akuter Myokardischämien Bei ACS-Symptomatik

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 249 (actual)
• Sponsor: Stiftung Institut fuer Herzinfarktforschung · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Chest Pain

Interventions

Type	Name	Description
OTHER	cardiogoniometry	In the course of the project a cardiogoniometry will be carried out during the ambulant or residential hospitalization before the coronary angiography.

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-04-01
• Completion: 2010-05-01
• First posted: 2011-04-05
• Last updated: 2011-04-05