Prognostic Value of Non-invasive Index of Endothelial Function.
Primary Purpose
Chest Pain, Major Adverse Cardiovascular Events
Status
Completed
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
Digital plethysmography in stratifying the cardiovascular risk for patients consulting for chest pain
Sponsored by
About this trial
This is an interventional other trial for Chest Pain focused on measuring endothelial function, chest pain, major adverse cardiovascular events, Endo-PAT
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.
Sites / Locations
- University hospital of Moastir
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patient consulting for chest Pain in ED
Arm Description
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).
Outcomes
Primary Outcome Measures
Prognostic performance of Endo-PAT in predincting major adverse cardiovascular events
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03164226
Brief Title
Prognostic Value of Non-invasive Index of Endothelial Function.
Official Title
Prognostic Value of Non-invasive Index of Endothelial Function in Emergency Department Patients With Undifferentiated Chest Pain
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
March 15, 2016 (Actual)
Primary Completion Date
September 15, 2017 (Actual)
Study Completion Date
September 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Monastir
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain, Major Adverse Cardiovascular Events
Keywords
endothelial function, chest pain, major adverse cardiovascular events, Endo-PAT
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective
Masking
None (Open Label)
Allocation
N/A
Enrollment
503 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient consulting for chest Pain in ED
Arm Type
Other
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Digital plethysmography in stratifying the cardiovascular risk for patients consulting for chest pain
Intervention Description
To verify the contribution of digital plethysmography in stratifying the cardiovascular risk for patients consulting for chest pain
Primary Outcome Measure Information:
Title
Prognostic performance of Endo-PAT in predincting major adverse cardiovascular events
Description
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
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
nouira semir, MD
Organizational Affiliation
University of Monastir
Official's Role
Principal Investigator
Facility Information:
Facility Name
University hospital of Moastir
City
Monastir
ZIP/Postal Code
5000
Country
Tunisia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Prognostic Value of Non-invasive Index of Endothelial Function.
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