Rapid Measurement of Adenosine in Syncope Patients

NCT05782712 | Completed

• 1 other identifier: 09C130
• Study Type: observational
• Target: 235
• Locations: 1 country
• Sites: 1

Brief Summary

Until now, a barrier to the widespread evaluation of adenosine in clinical practice has been the difficulty of obtaining rapid reliable measures. A rapid method has recently been developed which consists of measuring adenosine concentration in whole blood instead of plasma by means of Mass Spectrometry (LC-MS/MS). In this study adenosine plasma levels were assessed in a larger unselected cohort of patients affected by non-cardiac syncope and compared the results with healthy controls.

Conditions

Syncope

Keywords

Syncope; Adenosine

Outcome Measures

Primary Outcomes (1)

• Adenosine dosage

  Comparison of plasmatic adenosine value observed in the syncope group with that of control group

  2 hours

Study Arms (2)

Syncope

patients referred for syncope evaluation

Biological: adenosine dosage

No syncope

Subjects without syncope

Biological: adenosine dosage

Interventions

adenosine dosage BIOLOGICAL

Whole blood is collected using finger puncture followed by deposit a drop of blood (20 μL) using finnpipette, on a blotting paper (Whatman 903 protein saver cards™) and dried over night at room temperature to obtain dried blood spot (DBS).

No syncope; Syncope

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Syncope group: patients referred to the Syncope Unit of Auxologico with a diagnosis of possible or certain reflex syncope (class I diagnostic criteria of ESC guidelines) after exclusion of competing diagnoses. No syncope group: 1) Patients without a history of syncope, referred to Auxologico for other reasons; these patients have absence of severe structural heart disease and other comorbidities. 2) Healthy volunteers selected among personnel of Auxologico. The selection of these patients will be made matching them to syncope cases by age and sex.

You may qualify if:

• patients referred to the Syncope Unit of Auxologico with a diagnosis of possible or certain reflex syncope (class I diagnostic criteria of ESC guidelines)

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

IRCCS Istituto Auxologico Italiano

Milan, MI, 16149, Italy

Location

MeSH Terms

Conditions

Syncope

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2023
• First Posted: March 23, 2023
• Study Start: October 4, 2021
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Upon reasonable request after the publication of the principal study
• Access Criteria: m.brignole@auxologico.it

Locations

IT (1)