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Prognostic Value of Non-invasive Index of Endothelial Function.

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03164226
Enrollment
503
Registered
2017-05-23
Start date
2016-03-15
Completion date
2017-09-15
Last updated
2021-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chest Pain, Major Adverse Cardiovascular Events

Keywords

endothelial function, chest pain, major adverse cardiovascular events, Endo-PAT

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.

Interventions

DEVICEDigital 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

Sponsors

University of Monastir
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

Prospective

Eligibility

Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Prognostic performance of Endo-PAT in predincting major adverse cardiovascular events30 daysTo 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

Countries

Tunisia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026