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NCT00299143 Clinical Trial

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

Angina, Unstable Clinical Trial

— REACS  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00299143
Other study ID # RBM 04-24
Secondary ID
Status Completed
Phase N/A
First received March 2, 2006
Last updated December 27, 2011
Start date June 2005
Est. completion date June 2010

Study information
Verified date December 2011
Source Institut National de la Santé Et de la Recherche Médicale, France
Contact n/a
Is FDA regulated No
Health authority France: National Consultative Ethics Committee for Health and Life Sciences
Study type Observational

Clinical Trial 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

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 .

Recruitment information / eligibility
Status Completed
Enrollment 97
Est. completion date June 2010
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility 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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
France Bichat Hospital Paris

Sponsors (1)
Lead Sponsor Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

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