Cardiogoniometry (CGM) for Early Diagnosis of Acute Coronary Syndromes (ACS) (CGM@ACS)
| Tracking Information | |||||
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| First Received Date ICMJE | February 11, 2011 | ||||
| Last Updated Date | April 1, 2011 | ||||
| Start Date ICMJE | June 2009 | ||||
| Primary Completion Date | April 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Difference between cardiogoniometry finding and leading diagnoses of chest pain unit, coronary angiography, and at discharge in assessing the origin of chest pain [ Time Frame: 72 hours ] [ Designated as safety issue: No ] 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). |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01328795 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Cardiogoniometry (CGM) for Early Diagnosis of Acute Coronary Syndromes (ACS) | ||||
| Official Title ICMJE | Cardiogoniometry Zur Früherkennung Akuter Myokardischämien Bei ACS-Symptomatik | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE | Chest Pain | ||||
| Intervention ICMJE | Other: cardiogoniometry
In the course of the project a cardiogoniometry will be carried out during the ambulant or residential hospitalization before the coronary angiography. |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 249 | ||||
| Completion Date | May 2010 | ||||
| Primary Completion Date | April 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01328795 | ||||
| Other Study ID Numbers ICMJE | CGM@ACS | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Prof. Jochen Senges, Institut für Herzinfarktforschung Ludwigshafen an der Universität Heidelberg | ||||
| Study Sponsor ICMJE | Stiftung Institut fuer Herzinfarktforschung | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Stiftung Institut fuer Herzinfarktforschung | ||||
| Verification Date | April 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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