Assessment of the Mechanism of Non-cardiac Syncope

Last updated: July 16, 2024
Sponsor: Istituto Auxologico Italiano
Overall Status: Completed

Phase

N/A

Condition

Orthostatic Hypotension

Low Blood Pressure (Hypotension)

Dizzy/fainting Spells

Treatment

ABPM plys SCAFB

Clinical Study ID

NCT05728255
09C337
  • Ages > 18
  • All Genders

Study Summary

Identifying the mechanism of non-cardiac syncope is the essential prerequisite for an effective personalized therapy.

Aim of this multicentre, prospective, cross-sectional, observational study is to assess effectiveness and diagnostic yield of a two-step standardized assessment which consists of 24-hour ambulatory blood pressure monitoring (ABPM) and of tilt-table Short Cardiovascular Autonomic Function Battery (SCAFB) which consists in carotid sinus massage (CSM), limited to patients ≥40-year-old, standing test, and head-up tilt test (HUT) performed one after the other in an uninterrupted sequence as a single procedure on a tilt table

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • severe recurrent non-cardiac syncope referred for assessment of the mechanism ofsyncope. Non-cardiac syncope is diagnosed when the clinical features are consistentwith reflex syncope and orthostatic hypotension, and cardiac syncope is ruled out .

Exclusion

Exclusion Criteria:

  1. Non-syncopal causes of real or apparent loss of consciousness that may beincorrectly diagnosed as syncope (eg, unexplained falls, epilepsy, psychogenicpseudosyncope and other rare causes)

  2. Established or suspected cardiac syncope in complying with the criteria of theEuropean Society of Cardiology (ESC) syncope guidelines (1). Specifically, thesewere the patients with: (i) suspected cardiac arrhythmic syncope [inadequate sinusbradycardia (<50 b.p.m.) or sinoatrial block, second-degree Mobitz Iatrioventricular block, second-degree Mobitz II or third-degree atrioventricularblock, paroxysmal tachyarrhythmia or ventricular tachycardia, bundle branch block]; (ii) severe structural heart disease and/or significant ECG abnormalities, asdefined in Table 2 of those guidelines (1).

  3. Classical orthostatic hypotension diagnosed at the initial evaluation by ActiveStanding test

  4. Constitutional or drug-induced persistent hypotension already diagnosed at theinitial evaluation by office BP measurement or previous historical features

  5. Non-severe forms of non-cardiac syncope, i.e., patients with rare and mild episodesoccurring in low-risk situations. In these patients the investigation of theunderlying mechanism of syncope is not necessary and treatment strategies are mainlybased on education on preventive measures, lifestyle modification, and reassuranceregarding the benign nature of the condition.

Study Design

Total Participants: 330
Treatment Group(s): 1
Primary Treatment: ABPM plys SCAFB
Phase:
Study Start date:
April 01, 2024
Estimated Completion Date:
April 30, 2024

Study Description

Identifying the mechanism of non-cardiac syncope is the essential prerequisite for an effective personalized therapy. Indeed, the choice of appropriate therapy and its efficacy are largely determined by the mechanism of syncope rather than its aetiology or clinical presentation. The identified mechanism of syncope should be carefully assessed and assigned either to hypotensive or bradycardic phenotype, which will determine the choice of therapy (counteracting hypotension or counteracting bradycardia).

Several tests have been developed to identify the mechanism of non-cardiac syncope. The great number of tests, most of them being time-consuming, is one of the barriers for widespread utilization in the busy clinical practice. They are expensive and often not fully reimbursed by the health services.

Aim of this multicentre, prospective, cross-sectional, observational study is to assess effectiveness and diagnostic yield of a two-step standardized assessment which consists of 24-hour ambulatory blood pressure monitoring (ABPM) and of tilt-table Short Cardiovascular Autonomic Function Battery (SCAFB). SCAFB consists in carotid sinus massage (CSM), limited to patients ≥40-year-old, standing test, and head-up tilt test (HUT) performed one after the other in an uninterrupted sequence as a single procedure on a tilt table

The study hypothesis is that these two investigations, performed in sequence, can identify the mechanism of syncope in most of the patients in a quick and easy-to-perform way and at relatively low costs.

Connect with a study center

  • University of marseille Aix en Provence

    Marseille,
    France

    Site Not Available

  • IRCCS Istituto Auxologico Italiano

    Milan, MI 16149
    Italy

    Site Not Available

  • University of Florence

    Florence,
    Italy

    Site Not Available

  • ospdali del Tigullio

    Lavagna,
    Italy

    Site Not Available

  • Università della Campania Vamvitelli

    Naples,
    Italy

    Site Not Available

  • AMC Universisty of Amsterdam

    Amsterdam,
    Netherlands

    Site Not Available

  • University of Barcelona Vall d'Ebron

    Barcelona,
    Spain

    Site Not Available

  • Karolinska Institut

    Stockholm,
    Sweden

    Site Not Available

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