Cardiogoniometry (CGM) for Early Diagnosis of Acute Coronary Syndromes (ACS) (CGM@ACS)
Primary Purpose
Chest Pain
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cardiogoniometry
Sponsored by
About this trial
This is an interventional diagnostic trial for Chest Pain focused on measuring Cardiogoniometry, Chest Pain Unit, ST-elevation, Troponin, Catheter intervention, Fast Track
Eligibility Criteria
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
Sites / Locations
Outcomes
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
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT01328795
First Posted
February 11, 2011
Last Updated
April 1, 2011
Sponsor
Stiftung Institut fuer Herzinfarktforschung
1. Study Identification
Unique Protocol Identification Number
NCT01328795
Brief Title
Cardiogoniometry (CGM) for Early Diagnosis of Acute Coronary Syndromes (ACS)
Acronym
CGM@ACS
Official Title
Cardiogoniometry Zur Früherkennung Akuter Myokardischämien Bei ACS-Symptomatik
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Stiftung Institut fuer Herzinfarktforschung
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain
Keywords
Cardiogoniometry, Chest Pain Unit, ST-elevation, Troponin, Catheter intervention, Fast Track
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
249 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
cardiogoniometry
Intervention Description
In the course of the project a cardiogoniometry will be carried out during the ambulant or residential hospitalization before the coronary angiography.
Primary Outcome Measure Information:
Title
Difference between cardiogoniometry finding and leading diagnoses of chest pain unit, coronary angiography, and at discharge in assessing the origin of chest pain
Description
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).
Time Frame
72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jochen Senges, MD
Organizational Affiliation
Stiftung Institut fuer Herzinfarktfoschung
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Cardiogoniometry (CGM) for Early Diagnosis of Acute Coronary Syndromes (ACS)
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