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Clinical Trial Confirms Application of SRAclinic for Stroke Prevention
- Prospective trial at the university hospital Heidelberg considering the application of SRAclinic in stroke units shows convincing results.
- Fully automated SRAclinic from apoplex medical technologies for the detection of atrial fibrillation after stroke is superior to current diagnostic procedures and could help to prevent future strokes.
Apoplex medical technologies, Pirmasens, Geratherm Medical AG, Geschwenda May 26th, 2011. To prevent secondary strokes, it is of utmost importance to know the etiology of a stroke. Against this background, Prof. Dr. med. Roland Veltkamp presented today the up to date unpublished results of his prospective clinical trial for the "detection of paroxysmal atrial fibrillation at a stroke unit". The presentation was given during the 20th European Stroke Conference (ESC) at Hamburg (Germany). The trial was conducted from March 2010 to January 2011 at the stroke unit of the university hospital Heidelberg and included app. 600 patients. It compared the detection of atrial fibrillation under the application of SRAclinic (SRA = Stroke Risk Analysis) with the conventional procedure. Atrial fibrillation is considered as the most important risk factor for stroke.
SRAclinic is a fully automated ECG analysis for the detection of atrial fibrillation. It was developed by apoplex medical technologies GmbH from Pirmasens and is on the market.
Convincing trial results
The trial shows a significant superiority of SRAclinic in the detection of paroxysmal atrial fibrillation over conventional examination methods like 24 hour long term ECG or continuous ECG monitoring without automated analysis. A significant increase of the detection rate for patients with atrial fibrillation after ischemic stroke or TIA (transient ischemic attack) was reached with the application of SRAclinic. In total, 9.2 percent of the stroke patients were found with paroxysmal atrial fibrillation during their stay at the stroke unit.
With a combination of the admission ECG and the automated analysis of the ECG data from monitoring, 96.2 percent of the patients with paroxysmal atrial fibrillation were found. On the contrary, the more elaborate conventional 24 hour long term ECG in combination with the admission ECG detected only 58.5 percent of the patients with paroxysmal atrial fibrillation. As SRAclinic is using routine monitoring ECG data from the stroke unit anyway, it saves diagnostic resources.
Background to SRAclinic
SRAclinic is used in stroke units, which are special units for the treatment of stroke patients. The analysis of the ECG data is based on a patented mathematical procedure which interprets changes in the heart rate dynamics that occur in connection with atrial fibrillation. SRAclinic uses the routine ECG data from the patient monitoring system.
"The results of the trial and the strong potential of the method surprised us", said Prof. Dr. med. Roland Veltkamp, Neurologist at the university hospital Heidelberg, after his talk at the ESC. "Although doctors and nurses at our big stroke unit in Heidelberg are well aware of the importance of the documentation of atrial fibrillation after ischemic stroke for prevention of secondary strokes, the application of the automated analysis lead to a significant increase of newly detected patients with atrial fibrillation compared to the conventional ECG monitoring. Therefore the system could make an important contribution to the prevention of secondary strokes."
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