NCT03164226

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
503

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 23, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2017

Completed
Last Updated

December 9, 2021

Status Verified

December 1, 2021

Enrollment Period

1.5 years

First QC Date

May 14, 2017

Last Update Submit

December 1, 2021

Conditions

Chest PainMajor Adverse Cardiovascular Events

Keywords

endothelial functionchest painmajor adverse cardiovascular eventsEndo-PAT

Outcome Measures

Primary Outcomes (1)

  • 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

    30 days

Study Arms (1)

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).

Device: Digital plethysmography in stratifying the cardiovascular risk for patients consulting for chest pain

Interventions

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

Patient consulting for chest Pain in ED

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • Chest pain of traumatic origin.
  • Hemodynamic instability.
  • Myocardial infarction requiring urgent revascularization.
  • Parkinsonism: tremor problem.
  • Refusal, communication problem.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital of Moastir

Monastir, 5000, Tunisia

Location

MeSH Terms

Conditions

Chest Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • nouira semir, MD

    University of Monastir

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Prospective
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 14, 2017

First Posted

May 23, 2017

Study Start

March 15, 2016

Primary Completion

September 15, 2017

Study Completion

September 15, 2017

Last Updated

December 9, 2021

Record last verified: 2021-12

Locations

TU(1)