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Completed

NCT Number: NCT03164226

Prognostic Value of Non-invasive Index of Endothelial Function.

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.

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Key information

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University hospital of Moastir

Monastir, 5000, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Device

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

Primary outcomes

  1. Prognostic performance of Endo-PAT in predincting major adverse cardiovascular events

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Monastir

Other

Registry information

Official study title

Prognostic Value of Non-invasive Index of Endothelial Function in Emergency Department Patients With Undifferentiated Chest Pain

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 23, 2017
Registry last updated
Dec 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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