Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03164226 |
| Other study ID # |
ENDOPAT |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 15, 2016 |
| Est. completion date |
September 15, 2017 |
Study information
| Verified date |
December 2021 |
| Source |
University of Monastir |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
