Ignite Creation Date:
2024-05-05 @ 11:24 PM
Last Modification Date:
2024-10-26 @ 10:33 AM
Study NCT ID:
NCT01328795
Status:
COMPLETED
Last Update Posted:
2011-04-05
First Post:
2011-02-11
Brief Title:
Cardiogoniometry CGM for Early Diagnosis of Acute Coronary Syndromes ACS
Sponsor:
Stiftung Institut fuer Herzinfarktforschung
Organization:
Stiftung Institut fuer Herzinfarktforschung
Study Overview
Official Title:
Cardiogoniometry Zur Früherkennung Akuter Myokardischämien Bei ACS-Symptomatik
Status:
COMPLETED
Status Verified Date:
2011-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CGMACS
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 eg 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
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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None