ST Elevation in Acute Chest Pain; Could Measurement of Li... | NCT01041339

Studies
ST Elevation in Acute Chest Pain; Could Measurement of Lipoprotein-associated Phospholipase A2 (Lp-PLA2) be Helpful to the Clinician?

NCT01041339

Sponsor

Alexhander Izhaki

Status

Completed

Last Update Posted

Dec 15, 2015Estimated

Enrollment

40Actual

Phase

Not provided

Conditions

Acute Chest Syndrome

Interventions

Not provided

Countries

Israel

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

Jun 2011

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

Jan 2010

Primary Completion Date

Nov 2011Actual

Completion Date

Jan 2012Actual

First Submitted Date

Dec 30, 2009

First Submission Date that Met QC Criteria

Dec 30, 2009

First Posted Date

Dec 31, 2009Estimated

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 13, 2015

Last Update Posted Date

Dec 15, 2015Estimated

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

A blood test (2-3 cc peripheral venous blood) drawn /used from already available required lab tests to distinguish between pericarditis accompanied with electrocardiogram (ECG) signs mimicking infarction. A test of clinical potential if proven to be able to support either origin of acute chest pain etiology.

Detailed Description

Too many times young patients presenting with acute chest pain are referred to invasive angiography or treated with anticoagulation therapy a measure of detrimental effect in those inflicted with acute pericarditis.

A simple blood test (the PLAC test) may have some value in aiding rapid diagnosis saving need for cath.

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

Retention

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
acute chest pain ST elevation		patients admitted with acute chest pain sharing ST elevation in ER-ECG and elevated troponin
controls		asymptomatic patients

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

acute chest pain
acute ST elevation
elevated troponin I

Exclusion Criteria:

patients with recent (> 24 hour chest pain) myocardial infarction
refusing to provide blood samples

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

acute chest pain patients admitted to ICCU with acute ST elevation and elevated troponin

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alexander J Izhaki, MD	The E.Wolfson MC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The E.Wolfson MC		Holon		52100	Israel

Label	URL
Mayo Clin Proc. 2009;84(1):11-5.	View source

Condition Browse Module

MeSH Terms

ID	Term
D056586	Acute Chest Syndrome

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders
D000755	Anemia, Sickle Cell

Browse Leaves

Not provided

Browse Branches

Not provided