© 2003 by European Society of Cardiology
STUDY PROTOCOL
International Study on Syncope of Uncertain Etiology 2: the management of patients with suspected or certain neurally mediated syncope after the initial evaluation Rationale and study design
The Steering Committee of the ISSUE 2 studyDepartment of Cardiology, Ospedali del Tigullio, Via don Bobbio 16033 Lavagna, Italy
Abstract
STUDY DESIGN: Multi-centre, prospective observational study.
OBJECTIVES: Main objective is to verify the value of implantable loop recorder (ILR) in assessing the mechanism of syncope and the efficacy of the ILR-guided therapy after syncope recurrence.
INCLUSION CRITERIA: Patients who met the following criteria are included: suspected or definite neurally mediated syncope based on initial evaluation; 
3 syncope episodes in the last 2 years; severe clinical presentation of syncope requiring treatment initiation in the judgement of the investigator and age >30 years.
EXCLUSION CRITERIA: Patients with one or more of the following are excluded: carotid sinus syndrome; suspected or definite heart disease and high likelihood of cardiac syncope; symptomatic orthostatic hypotension diagnosed by standing blood pressure measurement; loss of consciousness different from syncope (e.g. epilepsy, psychiatric, metabolic, drop-attack, TIA, intoxication, cataplexy) and subclavian steal syndrome.
END-POINTS: The primary end-points are the ECG-documented syncopal events and the syncope recurrences after application of ILR-guided therapy.
SAMPLE SIZE AND DURATION: A minimum of 400 patients will be enrolled during an anticipated period of 3 years.
Key Words: Syncope, neurally mediated syncope, electrocardigraphic monitoring, implantable loop recorder
Correspondence: M. Brignole, Department of Cardiology, Ospedali del Tigullio, Via don Bobbio, 16033 Lavagna, Italy. Tel.: +39-0185329569; Fax: +39-0185306506; E-mail: mbrignole{at}asl4.liguria.it
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