Prognostic Value of Non-invasive Index of Endothelial Function.

University of Monastir

Status: Completed

Conditions: Major Adverse Cardiovascular Events; Chest Pain

Treatments: Device: Digital plethysmography in stratifying the cardiovascular risk for patients consulting for chest pain

Study type: Interventional

Funder types: Other

Identifiers

NCT03164226

ENDOPAT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 503 patients

Sex: All

Ages: 25+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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503 participants in 1 patient group

Patient consulting for chest Pain in ED

Other group

Description:

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).

Treatment:

Device: Digital plethysmography in stratifying the cardiovascular risk for patients consulting for chest pain