Evaluation of a novel portable capacitive ECG system in the clinical practice for a fast and simple ECG assessment in patients presenting with chest pain: FIDET (Fast Infarction Diagnosis ECG Trial).
BACKGROUND
Electrocardiogram (ECG) assessment plays a crucial role in patients presenting with chest pain and suspected acute coronary syndrome (ACS). In a pilot study, we previously evaluated a capacitive ECG system (cECG) as a novel ECG technique for a fast and simple ECG assessment in patients with ST-elevation myocardial infarction (STEMI). In a next step, the sensitivity and specificity of this novel ECG technique have to be assessed in patients with ACS.


OBJECTIVE
The Fast Infarction Diagnosis ECG Trial (FIDET) is a prospective, bi-center, observer-blinded noninferiority study to evaluate the cECG compared to the conventional ECG (kECG) in the clinical practice for ECG assessment in consecutive patients presenting with suspected ACS.


METHODS
In 250 patients who were admitted to the hospital, because of an ACS [including STEMI and non-ST-elevation acute coronary syndrome (NSTE-ACS)], both a kECG and a cECG recording were performed within a time lag of less than 10 min.


METHODS
The primary end point will be sensitivity and specificity of the cECG compared to the kECG in diagnosing a STEMI with a margin of noninferiority of 7.5 %. Secondary end points include sensitivity and specificity of the cECG compared to the kECG in diagnosing an NSTE-ACS, safety of the cECG system (adverse event, serious adverse event and suspected unexpected serious adverse reaction), parameters of the ECG measurement (PQ-interval, QT-interval, ST-amplitude and heart rate) and measurement duration of the two methods.


CONCLUSIONS
FIDET is designed as a noninferiority study to show that a novel cECG system is suitable for the diagnosis of myocardial infarction in the clinical context and might even have benefits, for example by offering a faster and easier ECG assessment.
Department of Cardiology and Pneumology/Heart Center, Georg-August-University Göttingen, Robert-Koch-Str. 40, 37075, Göttingen, Germany.
Eva C L
EC
Rasenack
Martin
M
Oehler
Albrecht
A
Elsässer
Meinhard
M
Schilling
Lars S
LS
Maier
D054058:Acute Coronary Syndrome / Q000150:complications / Q000175:diagnosis* / Q000503:physiopathology; D000787:Angina Pectoris / Q000175:diagnosis* / Q000209:etiology / Q000503:physiopathology; D004562:Electrocardiography / Q000295:instrumentation*; D004867:Equipment Design; D005858:Germany; D006339:Heart Rate; D006801:Humans; D009203:Myocardial Infarction / Q000150:complications / Q000175:diagnosis* / Q000503:physiopathology; D011237:Predictive Value of Tests; D011379:Prognosis; D011446:Prospective Studies; D015203:Reproducibility of Results; D012107:Research Design; D012680:Sensitivity and Specificity; D013997:Time Factors