NCT01041339

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 31, 2009

Completed
1 day until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

December 15, 2015

Status Verified

June 1, 2011

Enrollment Period

1.8 years

First QC Date

December 30, 2009

Last Update Submit

December 13, 2015

Conditions

Acute Chest Syndrome

Keywords

LpPLA2ST elevationacute pericarditis

Study Arms (2)

acute chest pain ST elevation

patients admitted with acute chest pain sharing ST elevation in ER-ECG and elevated troponin

controls

asymptomatic patients

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • acute chest pain
  • acute ST elevation
  • elevated troponin I

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The E.Wolfson MC

Holon, 52100, Israel

Location

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma kept in -80 celsius refrigerator

MeSH Terms

Conditions

Acute Chest Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersAnemia, Sickle CellAnemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Alexander J Izhaki, MD

    The E.Wolfson MC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 30, 2009

First Posted

December 31, 2009

Study Start

January 1, 2010

Primary Completion

November 1, 2011

Study Completion

January 1, 2012

Last Updated

December 15, 2015

Record last verified: 2011-06

Locations

IL(1)