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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00299143
First Posted: March 6, 2006
Last Update Posted: December 29, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nadine Ajzenberg, Institut National de la Santé Et de la Recherche Médicale, France
  Purpose
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
Angina, Unstable

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Pilot Study on Shear-induced Platelet Aggregation in Acute Coronary Syndromes

Further study details as provided by Nadine Ajzenberg, Institut National de la Santé Et de la Recherche Médicale, France:

Biospecimen Retention:   Samples Without DNA
serum, plasma, urines

Enrollment: 97
Study Start Date: June 2005
Study Completion Date: June 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
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 .
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients admitted in the intensive care unit with acute coronary syndrome
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00299143


Locations
France
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
  More Information

Responsible Party: Nadine Ajzenberg, professor, Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT00299143     History of Changes
Other Study ID Numbers: RBM 04-24
First Submitted: March 2, 2006
First Posted: March 6, 2006
Last Update Posted: December 29, 2011
Last Verified: December 2011

Keywords provided by Nadine Ajzenberg, Institut National de la Santé Et de la Recherche Médicale, France:
SIPA
acute coronary syndrome

Additional relevant MeSH terms:
Acute Coronary Syndrome
Angina, Unstable
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms