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

Study Overview

• Status: Completed
• Conditions: Chest Pain
• Intervention / Treatment: Other: cardiogoniometry

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 Type: Interventional
• Enrollment (Actual): 249
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Stiftung Institut fuer Herzinfarktforschung
• Investigators: Study Director: Jochen Senges, MD, Stiftung Institut fuer Herzinfarktfoschung

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (ACTUAL): April 1, 2010
• Study Completion (ACTUAL): May 1, 2010

Study Registration Dates

• First Submitted: February 11, 2011
• First Submitted That Met QC Criteria: April 1, 2011
• First Posted (ESTIMATE): April 5, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): April 5, 2011
• Last Update Submitted That Met QC Criteria: April 1, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: Troponin; Chest Pain Unit; Cardiogoniometry; ST-elevation; Catheter intervention; Fast Track
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chest Pain
• Other Study ID Numbers: CGM@ACS