Chest PainNCT03164226
Prognostic Value of Non-invasive Index of Endothelial Function.
A study testing Digital plethysmography in stratifying the cardiovascular risk for patients consulting for chest pain in people with Chest Pain and Major Adverse Cardiovascular Events, run by University of Monastir at 1 site in Tunisia.
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. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Chest Pain, Major Adverse Cardiovascular Events
- What is being tested?
- Digital plethysmography in stratifying the cardiovascular risk for patients consulting for chest pain
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 503 participants
- Where
- 1 siteTunisia
- Study dates
- 15 Mar 2016to 15 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Chest pain of traumatic origin.
- Hemodynamic instability.
- Myocardial infarction requiring urgent revascularization.
- Parkinsonism: tremor problem.
- Refusal, communication problem.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Value of Non-invasive Index of Endothelial Function in Emergency Department Patients With Undifferentiated Chest Pain
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.
Read the 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.
- Conditions
- Chest Pain, Major Adverse Cardiovascular Events
- Being tested
- Digital plethysmography in stratifying the cardiovascular risk for patients consulting for chest pain
- Keywords
- endothelial function, chest pain, major adverse cardiovascular events, Endo-PAT
- Medical subject headings
- Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital plethysmography in stratifying the cardiovascular risk for patients consulting for chest painDevice
To verify the contribution of digital plethysmography in stratifying the cardiovascular risk for patients consulting for chest pain
| Study group | Role | What they receive |
|---|---|---|
| Patient consulting for chest Pain in ED | Other | 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). Receives: Device: Digital plethysmography in stratifying the cardiovascular risk for patients consulting for chest pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study start15 Mar 2016
- Primary completion15 Sep 2017
- Study completion15 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chest PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective
- Masking
- None (open label)
- Enrolment
- 503 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
- Investigators
- nouira semir, MD, Principal investigator, University of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03164226
- Sponsor's protocol ID
- ENDOPAT
- Status last verified
- Dec 2021
- First submitted
- 14 May 2017
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dhaoui R, Hassine T, Ali KBH, Toumia M, Lamti F, Sekma A, Boubaker H, Yaakoubi H, Zorgati A, Boukef R, Bouida W, Msolli MA, Nouira S. Prognostic value of non-invasive endothelial function index in emergency department patients with undifferentiated chest pain. Heart Lung. 2026 Jan-Feb;75:34-39. doi: 10.1016/j.hrtlng.2025.09.005. Epub 2025 Sep 12.
PubMed 40945430
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Non-invasive Index of Endothelial Function in Emergency Department Patients With Undifferentiated Chest Pain
- ClinicalTrials.gov ID
- NCT03164226
- Acronym / sponsor ID
- ENDOPAT
- Conditions
- Chest Pain, Major Adverse Cardiovascular Events
- Keywords
- endothelial function, chest pain, major adverse cardiovascular events, Endo-PAT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 503 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 15 Mar 2016 (actual)
- Primary completion
- 15 Sep 2017 (actual)
- Study completion
- 15 Sep 2017 (actual)
- First posted
- 23 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective
| Arm | Type | Receives |
|---|---|---|
| Patient consulting for chest Pain in ED | Other | Device: Digital plethysmography in stratifying the cardiovascular risk for patients consulting for chest painAny 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). |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (5 listed)
- Chest pain of traumatic origin.
- Hemodynamic instability.
- Myocardial infarction requiring urgent revascularization.
- Parkinsonism: tremor problem.
- Refusal, communication problem.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital plethysmography in stratifying the cardiovascular risk for patients consulting for chest painTo verify the contribution of digital plethysmography in stratifying the cardiovascular risk for patients consulting for chest pain | Device | Patient consulting for chest Pain in ED |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
- Derived from this study: PubMed 40945430Dhaoui R, Hassine T, Ali KBH, Toumia M, Lamti F, Sekma A, Boubaker H, Yaakoubi H, Zorgati A, Boukef R, Bouida W, Msolli MA, Nouira S. Prognostic value of non-invasive endothelial function index in emergency department patients with undifferentiated chest pain. Heart Lung. 2026 Jan-Feb;75:34-39. doi: 10.1016/j.hrtlng.2025.09.005. Epub 2025 Sep 12.
- Individual participant dataSharing planned: Undecided
Related trials for Chest Pain
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CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
nouira semir, MD principal investigator
University of Monastir
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital plethysmography in stratifying the cardiovascular risk for patients consulting for chest pain in people with Chest Pain and Major Adverse Cardiovascular Events, run by University of Monastir at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognostic performance of Endo-PAT in predincting major adverse cardiovascular events (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03164226, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2021.