NCT02887066

Brief Summary

The purpose is to build up a data observatory of individuals with thoracic pain evoking acute coronary syndrome (ACS). The aim is the characterization of this population of patients consulting at emergency department, the evaluation of therapeutic strategies with regard to guidelines and the becoming of patients including severe complications and mortality.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
580

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

Status
unknown

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

September 1, 2014

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 7, 2016

Status Verified

August 1, 2016

Enrollment Period

2 years

First QC Date

August 19, 2016

Last Update Submit

September 6, 2016

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (7)

  • Mortality

    30 days

  • Mortality

    1 year

  • Severe complications

    30 days

  • Severe complications

    1 year

  • Benefit/risk ratio of treatments

    day 0

  • Benefit/risk ratio of treatments

    30 days

  • Benefit/risk ratio of treatments

    1 year

Study Arms (1)

Patients with thoracic pain and suspicion of ACS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients hospitalized in emergency room or under medical care in mobile intensive care units for thoracic pain and suspicion of ACS.

You may qualify if:

  • Resident in Grand Est of France (Lorraine, Champagne Ardenne) under medical care at the emergency room or outside of hospital or in cardiology:
  • Outside of hospital: for thoracic or epigastric pain with suspicion of ACS Emergency: for thoracic pain for which the doctor will prescribe troponin or troponin kinetics
  • Affiliation to social security

You may not qualify if:

  • Patient affected by ACS with ST segment elevation
  • Patient with traumatic thoracic pain
  • Patient with thoracic pain of parietal origin
  • Patient with consciousness troubles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Tahar Chouihed

    Service SAMU - SMUR - SAU, Hôpital Central, CHRU de Nancy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2016

First Posted

September 1, 2016

Study Start

September 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

September 7, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share