NCT00299143

Brief Summary

The purpose of this study is to determine whether shear-induced platelet aggregation is able to discriminate first acute coronary syndrome (ACS) from recurrent ACS

Trial Health

87
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2005

Longer than P75 for all trials

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

Study Start

First participant enrolled

June 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 6, 2006

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

December 29, 2011

Status Verified

December 1, 2011

Enrollment Period

4.3 years

First QC Date

March 2, 2006

Last Update Submit

December 27, 2011

Conditions

Angina, Unstable

Keywords

SIPAacute coronary syndrome

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients admitted in the intensive care unit with acute coronary syndrome

You may qualify if:

  • over 18 years old. informed consent signed. acute coronary syndrome not associated with co-morbidity as bleeding diathesis or myocardial infarction during the procedure.
  • clinical symptoms in agreement with myocardial infarction during the preceding 24 hours.
  • CK OR troponin elevation and one or more of the following criteria: ECG modifications transient ST elevation\>1 mm. new inversion of ST \<1 mm on 2 contiguous derivations.

You may not qualify if:

  • Acute coronary syndrome with persistent ST elevation. Angioplasty in emergency before blood sampling. Inflammatory disease or cancer. Coagulation abnormalities. Antiphospholipid syndrome. Treatment by vitamin K antagonist. Severe disease with life expectancy lower than 2 years. One-year follow up impossible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bichat Hospital

Paris, 75018, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum, plasma, urines

MeSH Terms

Conditions

Angina, UnstableAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Philippe G Steg, Professor

    APHP

    STUDY DIRECTOR

  • Nadine Ajzenberg, Dr

    APHP, INSERM

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 2, 2006

First Posted

March 6, 2006

Study Start

June 1, 2005

Primary Completion

September 1, 2009

Study Completion

June 1, 2010

Last Updated

December 29, 2011

Record last verified: 2011-12

Locations

FR(1)