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

Michele Brignole, Richard Sutton, Carlo Menozzi, Angel Moya, Roberto Garcia-Civera, David Benditt, Panos Vardas, Wouter Wieling, Dietrich Andresen, Roberta Migliorini, David Hollinworth

Research output: Contribution to journalArticlepeer-review

14 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)317-321
Number of pages5
JournalEuropace
Volume5
Issue number3
DOIs
StatePublished - Jul 2003

Keywords

  • Electrocardigraphic monitoring
  • Implantable loop recorder
  • Neurally mediated syncope
  • Syncope

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