NCT05728255

Assessment of the Mechanism of Non-cardiac Syncope

Assessment of the Mechanism of Non-cardiac Syncope by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) and Tilt-table Short Cardiovascular Autonomic Function Battery (SCAFB)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 330 (actual)
• Sponsor: Istituto Auxologico Italiano · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Syncope
• Syncope, Vasovagal
• Orthostatic Hypotension
• Syncope, Carotid Sinus

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	ABPM plys SCAFB	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

Timeline

• Start date: 2024-04-01
• Primary completion: 2024-04-30
• Completion: 2024-04-30
• First posted: 2023-02-15
• Last updated: 2024-07-17

Locations

8 sites across 5 countries: France, Italy, Netherlands, Spain, Sweden