Myeloid-Related Protein in Evaluation of Acute Chest Pain... | NCT00657436

Studies
Myeloid-Related Protein in Evaluation of Acute Chest Pain in the Emergency Departement

NCT00657436

Sponsor

University of Zurich

Status

Completed

Last Update Posted

May 31, 2012Estimated

Enrollment

403Actual

Phase

Not provided

Conditions

Myocardial Ischemia
Acute Coronary Syndrome
Myocardial Infarction
Coronary Occlusion
Coronary Thrombosis

Interventions

Not provided

Countries

Switzerland

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

May 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 2008

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Apr 8, 2008

First Submission Date that Met QC Criteria

Apr 8, 2008

First Posted Date

Apr 14, 2008Estimated

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

May 30, 2012

Last Update Posted Date

May 31, 2012Estimated

Name	Class
Swiss National Science Foundation	OTHER

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 of the study is the evaluation of multiple biomarkers related to acute coronary syndromes, including myeloid-related protein 8/14 (MRP 8/14), along with established clinical markers, for early diagnosis and risk stratification in patients presenting with acute chest pain at the emergency department.

Study hypothesis: MRP 8/14, alone or together with other established or new biomarkers, increases the earliness, sensitivity, and specificity of diagnosing acute coronary syndromes.

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

Not provided

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

403Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnosis of acute coronary syndrome		Emergency room and/or hospital stay

Secondary Outcomes

Measure	Description	Time Frame
Incidence of any acute coronary event		1 year
Morbidity from coronary artery disease		1 year
Mortality

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients in the emergency department of the University Hospital Zurich with measurement of troponin during the routine diagnostic evaluation.

Exclusion Criteria:

Refusal or inability to give informed consent.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Consecutive patients - systematic sampling - presenting with acute chest pain at the emergency room in which determination of cardiac biomarkers is indicated for clinical diagnostics

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Willibald Maier, MD	Cardiology, University Hospital Zurich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cardiology, University Hospital		Zurich		8091	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17387139	Background	Altwegg LA, Neidhart M, Hersberger M, Muller S, Eberli FR, Corti R, Roffi M, Sutsch G, Gay S, von Eckardstein A, Wischnewsky MB, Luscher TF, Maier W. Myeloid-related protein 8/14 complex is released by monocytes and granulocytes at the site of coronary occlusion: a novel, early, and sensitive marker of acute coronary syndromes. Eur Heart J. 2007 Apr;28(8):941-8. doi: 10.1093/eurheartj/ehm078. Epub 2007 Mar 26.

ID	Term
D017202	Myocardial Ischemia
D054058	Acute Coronary Syndrome
D009203	Myocardial Infarction
D054059	Coronary Occlusion
D003328	Coronary Thrombosis
D003324	Coronary Artery Disease

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases
D007238	Infarction