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Clinical Trials/NCT03164226
NCT03164226
Completed
Not Applicable

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

University of Monastir1 site in 1 country503 target enrollmentMarch 15, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chest Pain
Sponsor
University of Monastir
Enrollment
503
Locations
1
Primary Endpoint
Prognostic performance of Endo-PAT in predincting major adverse cardiovascular events
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 15, 2016
End Date
September 15, 2017
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Pr. Semir Nouira

Professor

University of Monastir

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.

Outcomes

Primary Outcomes

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

Study Sites (1)

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