Acute Coronary Syndome With ST Elevation in Northern Lorr... | NCT03355898

Studies
Acute Coronary Syndome With ST Elevation in Northern Lorraine

NCT03355898

Sponsor

Centre Hospitalier Régional Metz-Thionville

Status

Completed

Last Update Posted

Nov 30, 2017Actual

Enrollment

340Actual

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

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016Actual

Primary Completion Date

Apr 2016Actual

Completion Date

Jun 2016Actual

First Submitted Date

Nov 23, 2017

First Submission Date that Met QC Criteria

Nov 23, 2017

First Posted Date

Nov 28, 2017Actual

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

Nov 29, 2017

Last Update Posted Date

Nov 30, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Lorraine is one of the most affected French region by cardiovascular diseases with a mortality rate for ischemic heart disease higher than the national average in 2010. Due to practice change with the new recommandations of the European Society of Cardiology involving the myocardic revascularization, the investigators wanted to compare the Stemi care in 2005-2006, 2010-2011 and 2015 in the CHR Metz-Thionville.

Detailed Description

This monocentric study evaluate the impact of the new recommandations of the European Society of Cardiology in the acute coronary syndrome with ST elevation (Stemi) care. Data is compiled retrospectively from angiographic report and informatic medical record.

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

340Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Acute coronary syndrome with ST elevation care	Percentage of per-cutaneous angioplasty and percentage of pre-hospital thrombolysis	Day 1

Secondary Outcomes

Measure	Description	Time Frame
Stenting procedure	Percentage of manual thrombectomy and percentage of direct stenting	Day 1
Hospital mortality	Percentage of death during the STEMI care

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient with an acute coronary syndrome with ST elevation for less than 12 hours
Patients with coronarography in a context of cardiorespiratory arrest with unknown cause and acute coronary occlusion

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with an acute coronary syndrome with ST elevation in the CHR Metz-Thionville in 2005-2006, 2010-2011 and 2015

Sampling Method

Non-Probability Sample

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