Validation of a High-risk Versus Low-risk Referral Model... | NCT01747421

Studies
Validation of a High-risk Versus Low-risk Referral Model in Suspected Acute Coronary Syndrome

NCT01747421

Sponsor

University of Southern Denmark

Status

Completed

Last Update Posted

Dec 11, 2012Estimated

Enrollment

495Actual

Phase

Not provided

Conditions

Acute Myocardial Infarction

Interventions

Not provided

Countries

Denmark

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

Dec 2012

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 2009

Primary Completion Date

Sep 2009Actual

Completion Date

Sep 2010Actual

First Submitted Date

Dec 7, 2012

First Submission Date that Met QC Criteria

Dec 7, 2012

First Posted Date

Dec 11, 2012Estimated

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

Dec 7, 2012

Last Update Posted Date

Dec 11, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Christian Backer Mogensen, assistant professor, University of Southern DenmarkPrincipal Investigator

Lead Sponsor

University of Southern DenmarkOTHER

Collaborators

Not provided

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

In Emergency Departments patients admitted with chest pain may suffer from non-significant to lifethreatening conditions.

The aim of the present study is to develop and validate a referral model in chest pain patients which divide the patients with non- significant ECG changes into high risk and low risk groups for acute coronary syndrome.

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

495Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Acute Myocardial Infarction		24 hours after admission

Secondary Outcomes

Measure	Description	Time Frame
cardiac event		1 year after admission

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

more than 15 years old

Exclusion Criteria:

Patients with ST-elevations in ECG

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

all acute admission to Emergency Department with the complaint Chestpain

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kolding Hospital		Kolding		6000	Denmark