Clinical trial NCT03164226: Prognostic Value of Non-invasive Index of Endothelial Function.
Official title: Prognostic Value of Non-invasive Index of Endothelial Function in Emergency Department Patients With Undifferentiated Chest Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chest Pain
Major Adverse Cardiovascular Events
Keywords: endothelial function
chest pain
major adverse cardiovascular events
Endo-PAT
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2017-05-23
Enrollment: 503
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prognostic performance of Endo-PAT in predincting major adverse cardiovascular events
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: University hospital of Moastir
Study officials:
affiliation: University of Monastir
name: nouira semir, MD
role: PRINCIPAL_INVESTIGATOR
References: