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REACS: Pilot Study on Shear-induced Platelet Aggregation in Acute Coronary Syndromes

Sponsor
Institut National de la Santé Et de la Recherche Médicale, France (Other)
Overall Status
Completed
CT.gov ID
NCT00299143
Collaborator
(none)
97
Enrollment
1
Location
60
Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Predictive factors of recurrence of ACS are not well determined. Platelet aggregation and leucocyte activation seem to be involved in the pathogenesis. The aim of our study is to compare SIPA, platelet activation and platelet-leucocytes aggregates on the onset of the ACS and 3 months later in 2 groups of patients scheduled for a first episode of ACS or recurrent ACS .

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    97 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Pilot Study on Shear-induced Platelet Aggregation in Acute Coronary Syndromes
    Study Start Date :
    Jun 1, 2005
    Actual Primary Completion Date :
    Sep 1, 2009
    Actual Study Completion Date :
    Jun 1, 2010

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 85 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:

      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.

      Exclusion criteria:

      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.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Bichat Hospital Paris France 75018

      Sponsors and Collaborators

      • Institut National de la Santé Et de la Recherche Médicale, France

      Investigators

      • Study Director: Philippe G Steg, Professor, APHP
      • Principal Investigator: Nadine Ajzenberg, Dr, APHP, INSERM

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Nadine Ajzenberg, professor, Institut National de la Santé Et de la Recherche Médicale, France
      ClinicalTrials.gov Identifier:
      NCT00299143
      Other Study ID Numbers:
      • RBM 04-24
      First Posted:
      Mar 6, 2006
      Last Update Posted:
      Dec 29, 2011
      Last Verified:
      Dec 1, 2011
      Keywords provided by Nadine Ajzenberg, professor, Institut National de la Santé Et de la Recherche Médicale, France
      SIPA
      acute coronary syndrome
      Additional relevant MeSH terms:
      Acute Coronary Syndrome
      Angina, Unstable

      Study Results

      No Results Posted as of Dec 29, 2011