Angina, UnstableREACSNCT00299143
Pilot Study on Shear-induced Platelet Aggregation in Acute Coronary Syndromes
An observational study of Angina, Unstable, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Angina, Unstable
- How many people
- 97 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2005to Jun 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients admitted in the intensive care unit with acute coronary syndrome
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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 .
- Conditions
- Angina, Unstable
- Keywords
- SIPA, acute coronary syndrome
- Medical subject headings
- Angina, Unstable, Acute Coronary Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of platelet aggregation induced by shear rates
Using rotational viscometer
Measured: Day 1, Month 3
Secondary outcomes (5)
Measurement of platelet aggregation induced by ADP (Adenosine 5'-diphosphate)
Measured by turbidimetry in the of the agonist, at 37°C in an aggregometer (model 490, Chonolog)
Measured: Day 1, Month 3
Measurement of P-selectin membrane density
By flow cytometry (EPICS Profile, Beckman, Coulter)
Measured: Day 1, Month 3
Measurement of activated alphaIlbbeta3 membrane density
By flow cytometry (EPICS Profile, Beckman, Coulter)
Measured: Day 1, Month 3
Determination of the number of platelet-leucocyte aggregates in the circulating blood
By flow cytometry, using antibodies specific to platelets (CD41), polymorphonuclear cells (CD15) and monocytes labelled with a fluorochrome (FITC)
Measured: Day 1, Month 3
Measuring Von Willebrand factor
Carried out on frozen plasma of all patients
Measured: Day 1, Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2006 (estimated)
- Study startJun 2005
- Primary completionSep 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Angina, UnstableStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Philippe G Steg, Professor, Study director, APHPNadine Ajzenberg, Dr, Principal investigator, APHP, INSERM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00299143
- Sponsor's protocol ID
- RBM 04-24
- Acronym
- REACS
- Status last verified
- Dec 2011
- First submitted
- 2 Mar 2006
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22204850
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on Shear-induced Platelet Aggregation in Acute Coronary Syndromes
- ClinicalTrials.gov ID
- NCT00299143
- Acronym / sponsor ID
- REACS / RBM 04-24
- Conditions
- Angina, Unstable
- Keywords
- SIPA, acute coronary syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- Jun 2005
- Primary completion
- Sep 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 6 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients admitted in the intensive care unit with acute coronary syndrome
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measurement of platelet aggregation induced by shear rates
Time frame: Day 1, Month 3
Using rotational viscometer
5 secondary outcomes
Measurement of platelet aggregation induced by ADP (Adenosine 5'-diphosphate)
Time frame: Day 1, Month 3
Measurement of P-selectin membrane density
Time frame: Day 1, Month 3
Measurement of activated alphaIlbbeta3 membrane density
Time frame: Day 1, Month 3
Determination of the number of platelet-leucocyte aggregates in the circulating blood
Time frame: Day 1, Month 3
Measuring Von Willebrand factor
Time frame: Day 1, Month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Results publication: PubMed 22204850Ajzenberg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe G Steg, Professor study director
APHP
Nadine Ajzenberg, Dr principal investigator
APHP, INSERM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Angina, Unstable, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of platelet aggregation induced by shear rates (time frame: Day 1, Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00299143, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.