Prognostic Value of Non-invasive Index of Endothelial Function.

Not Applicable

Completed

• Conditions: Chest Pain; Major Adverse Cardiovascular Events
• Interventions: Device: Digital plethysmography in stratifying the cardiovascular risk for patients consulting for chest pain

• Registration Number: NCT03164226
• Lead Sponsor: University of Monastir

Brief Summary

The objective of this study is to determine the prognostic performance of endothelial function assessment, using endothelial peripheral arterial tonometry (Endo-PAT), associated to TIMI risk score, in patients consulting the emergency department for non-traumatic chest pain.

To determine the sensitivity, specificity, negative and positive predictive value of this method that was not previously used for this purpose.

Detailed Description

Chest pain is a frequent reason for consultation in the emergency room, which can be as much as 5 to 10% of consultants. Stratifying the cardiovascular risk for patients consulting for chest pain is sometimes difficult.

The endothelium plays a crucial role in maintaining the tone and vascular integrity and in particular the secretion of vasodilator and vasoconstrictor mediators. In most vascular pathologies, this equilibrium will be broken by the attenuation of the vasodilating function of the endothelium. This is called endothelial dysfunction.

Several tools for measuring endothelial function have been developed, the main characteristics of which are: noninvasive, reproducible, independent operators, predictive of the disease, safe for subjects, inexpensive and easy to use.

In this study we will be interested in digital plethysmography which has shown its effectiveness in:

* Screening for cardiovascular risk in asymptomatic subjects.

* The risk of a new cardiovascular event in the sick.

* Evaluation of the response to certain therapies.

Goal of the study :

The objective of this study is to to determine the prognostic performance of endothelial function assessment, using endothelial peripheral arterial tonometry (Endo-PAT), associated to TIMI risk score, in patients consulting the emergency department for non-traumatic chest pain.

To determine the sensitivity, specificity, negative and positive predictive value of this method that was not previously used for this purpose, hence the originality of this study.

Study Timeline

• Study Start: 2016-03-15
• Study First Submitted: 2017-05-14
• Study First Submitted QC: 2017-05-22
• Study First Posted: 2017-05-23
• Primary Completion: 2017-09-15
• Study Completion: 2017-09-15
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-01
• Last Update Posted: 2021-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 503

Inclusion Criteria

• Any patient ≥ 25 years consulting for chest pain in the emergency department from 8:00 am to 8:00 pm (for the unavailability of the endopat device during the guard).

Exclusion Criteria

• Chest pain of traumatic origin.
• Hemodynamic instability.
• Myocardial infarction requiring urgent revascularization.
• Parkinsonism: tremor problem.
• Refusal, communication problem.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient consulting for chest Pain in ED	Digital plethysmography in stratifying the cardiovascular risk for patients consulting for chest pain	Any patient ≥ 25 years consulting for chest pain in the emergency department from 8:00 am to 8:00 pm (for the unavailability of the endopat device during the guard).

Primary Outcome Measures

Name	Time	Method
Prognostic performance of Endo-PAT in predincting major adverse cardiovascular events	30 days	To determine the sensitivity, specificity, negative and positive predictive value of the Endopat associated to TIMI risk score in the the prediction of major adverse cardiovascular events in patients consulting the emergency department for chest pain

Trial Locations

Locations (1)

University hospital of Moastir; 🇹🇳 Monastir, Tunisia