Observatory on Emergency Care for Acute Coronary Syndrome... | NCT02887066

Studies
Observatory on Emergency Care for Acute Coronary Syndrome in Grand Est of France

NCT02887066

Sponsor

Central Hospital, Nancy, France

Status

Unknown status

Last Update Posted

Sep 7, 2016Estimated

Enrollment

580Actual

Phase

Not provided

Conditions

Acute Coronary Syndrome

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Sep 2016Estimated

Completion Date

Sep 2016Estimated

First Submitted Date

Aug 19, 2016

First Submission Date that Met QC Criteria

Aug 29, 2016

First Posted Date

Sep 1, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 6, 2016

Last Update Posted Date

Sep 7, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

580Actual

Label	Type	Description	Intervention Names
Patients with thoracic pain and suspicion of ACS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tahar Chouihed	Service SAMU - SMUR - SAU, Hôpital Central, CHRU de Nancy	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D054058	Acute Coronary Syndrome

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided