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

July 13, 2026

Status Verified

December 1, 2011

Enrollment Period

4.3 years

First QC Date

March 2, 2006

Last Update Submit

July 10, 2026

Conditions

Keywords

SIPAacute coronary syndrome

Outcome Measures

Primary Outcomes (1)

  • Measurement of platelet aggregation induced by shear rates

    Using rotational viscometer

    Day 1, Month 3

Secondary Outcomes (5)

  • Measurement of platelet aggregation induced by ADP (Adenosine 5'-diphosphate)

    Day 1, Month 3

  • Measurement of P-selectin membrane density

    Day 1, Month 3

  • Measurement of activated alphaIlbbeta3 membrane density

    Day 1, Month 3

  • Determination of the number of platelet-leucocyte aggregates in the circulating blood

    Day 1, Month 3

  • Measuring Von Willebrand factor

    Day 1, Month 3

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

Related Publications (1)

  • Ajzenberg N, Ducrocq G, Farnoud R, Huisse MG, Alavoine L, Duval X, Mentre F, Steg PG. Recurrent acute coronary syndromes are associated with increased shear induced platelet aggregation. A case-control study. Int J Cardiol. 2012 Mar 8;155(2):313-4. doi: 10.1016/j.ijcard.2011.12.005. Epub 2011 Dec 26. No abstract available.

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
SPONSOR

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

July 13, 2026

Record last verified: 2011-12

Locations