Assessment of the Mechanism of Non-cardiac Syncope

NCT05728255 | Completed

• 1 other identifier: 09C337
• Study Type: observational
• Target: 330
• Locations: 5 countries
• Sites: 8

Brief 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

Conditions

Syncope; Syncope, Vasovagal; Orthostatic Hypotension; Syncope, Carotid Sinus

Keywords

Syncope; Orthostatic hypotension; Tilt table test; Ambulatory blood pressure monitoring

Outcome Measures

Primary Outcomes (1)

• Prevalence

  Prevalence of hypotensive and bradycardic phenotypes

  1 month

Secondary Outcomes (2)

• Diagnostic yield

  1 month

• Diagnosis

  1 month

Interventions

ABPM plys SCAFB DIAGNOSTIC_TEST

24-hour ambulatory blood pressure monitoring (ABPM) and of tilt-table Short Cardiovascular Autonomic Function Battery (SCAFB) which consists in carotid sinus massage (CSM) 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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with severe syncopes are those patients who are asking for mechanism-specific therapy because they are affected by recurrent syncopes impairing quality of life or have syncopes with absent or very short prodrome increasing the risk of injuries or are at risk of syncope during high-risk activities (e.g., driving, machine operation, flying, or competitive athletics, etc.).

You may qualify if:

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

You may not qualify if:

• Non-syncopal causes of real or apparent loss of consciousness that may be incorrectly diagnosed as syncope (eg, unexplained falls, epilepsy, psychogenic pseudosyncope and other rare causes)
• Established or suspected cardiac syncope in complying with the criteria of the European Society of Cardiology (ESC) syncope guidelines (1). Specifically, these were the patients with: (i) suspected cardiac arrhythmic syncope \[inadequate sinus bradycardia (\<50 b.p.m.) or sinoatrial block, second-degree Mobitz I atrioventricular block, second-degree Mobitz II or third-degree atrioventricular block, paroxysmal tachyarrhythmia or ventricular tachycardia, bundle branch block\]; (ii) severe structural heart disease and/or significant ECG abnormalities, as defined in Table 2 of those guidelines (1).
• Classical orthostatic hypotension diagnosed at the initial evaluation by Active Standing test
• Constitutional or drug-induced persistent hypotension already diagnosed at the initial evaluation by office BP measurement or previous historical features
• Non-severe forms of non-cardiac syncope, i.e., patients with rare and mild episodes occurring in low-risk situations. In these patients the investigation of the underlying mechanism of syncope is not necessary and treatment strategies are mainly based on education on preventive measures, lifestyle modification, and reassurance regarding the benign nature of the condition.

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (8)

University of marseille Aix en Provence

Marseille, France

Location

IRCCS Istituto Auxologico Italiano

Milan, MI, 16149, Italy

Location

University of Florence

Florence, Italy

Location

ospdali del Tigullio

Lavagna, Italy

Location

Università della Campania Vamvitelli

Naples, Italy

Location

AMC Universisty of Amsterdam

Amsterdam, Netherlands

Location

University of Barcelona Vall d'Ebron

Barcelona, Spain

Location

Karolinska Institut

Stockholm, Sweden

Location

Related Publications (2)

• Rivasi G, Groppelli A, Brignole M, Soranna D, Zambon A, Bilo G, Pengo M, Sharad B, Hamrefors V, Rafanelli M, Testa GD, Rice C, Kenny RA, Sutton R, Ungar A, Fedorowski A, Parati G. Association between hypotension during 24 h ambulatory blood pressure monitoring and reflex syncope: the SynABPM 1 study. Eur Heart J. 2022 Oct 11;43(38):3765-3776. doi: 10.1093/eurheartj/ehac347.

  PMID: 35766175 BACKGROUND

• Brignole M, Rivasi G. New insights in diagnostics and therapies in syncope: a novel approach to non-cardiac syncope. Heart. 2021 Jun;107(11):864-873. doi: 10.1136/heartjnl-2020-318261. Epub 2021 Jan 18.

  PMID: 33462120 RESULT

MeSH Terms

Conditions

Syncope; Syncope, Vasovagal; Hypotension, Orthostatic

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Hypotension; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2023
• First Posted: February 15, 2023
• Study Start: April 1, 2024
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); FR (1); ES (1); IT (4); SE (1)