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

NCT01328795 | Completed

• 1 other identifier: CGM@ACS
• Study Type: interventional
• Target: 249
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chest Pain

Keywords

Cardiogoniometry; Chest Pain Unit; ST-elevation; Troponin; Catheter intervention; Fast Track

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

cardiogoniometry OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• thoracic pain, or pain radiating to neck or arm, or acute dyspnoea
• coronary angiography within 72 hours after start of symptoms

You may not qualify if:

• 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

Sponsors & Collaborators

• Stiftung Institut fuer Herzinfarktforschung: lead

MeSH Terms

Conditions

Chest Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jochen Senges, MD

  Stiftung Institut fuer Herzinfarktfoschung

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 11, 2011
• First Posted: April 5, 2011
• Study Start: June 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: May 1, 2010
• Last Updated: April 5, 2011

Record last verified: 2011-04