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Prognostic Value of Non-invasive Index of Endothelial Function.

NCT ID: NCT03164226

Last Updated: 2021-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

503 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-15

Study Completion Date

2017-09-15

Brief Summary

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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

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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.

Conditions

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Chest Pain Major Adverse Cardiovascular Events

Keywords

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endothelial function chest pain major adverse cardiovascular events Endo-PAT

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patient consulting for chest Pain in ED

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).

Group Type OTHER

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

Intervention Type DEVICE

To verify the contribution of digital plethysmography in stratifying the cardiovascular risk for patients consulting for chest pain

Interventions

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

To verify the contribution of digital plethysmography in stratifying the cardiovascular risk for patients consulting for chest pain

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Monastir

OTHER

Sponsor Role lead

Responsible Party

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Pr. Semir Nouira

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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nouira semir, MD

Role: PRINCIPAL_INVESTIGATOR

University of Monastir

Locations

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University hospital of Moastir

Monastir, , Tunisia

Site Status

Countries

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Tunisia

Other Identifiers

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ENDOPAT

Identifier Type: -

Identifier Source: org_study_id