Status:
COMPLETED
Discovery of New Circulating Biomarkers of Coronary Atherosclerosis
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Fédération Française de Cardiologie
Société Française de Cardiologie
Conditions:
Coronary Artery Disease
Acute Coronary Syndromes
Eligibility:
All Genders
18-80 years
Brief Summary
The study hypothesis is that differential proteomic techniques can be used to discover new circulating biomarkers of coronary atherosclerosis in the blood of patients suffering from coronary artery di...
Detailed Description
Hypothesis: Our hypothesis is that coronary atherosclerosis induces both quantitative and qualitative modifications of circulating proteins, which can be captured by a differential proteomic approach ...
Eligibility Criteria
Inclusion
- Group 1 (Non-ST-elevation acute myocardial infarction) :
- Chest pain less than 48 hours before admission,
- And modifications of ST-T (no persistent ST elevation) on 12-lead EKG,
- And elevation of troponin-I \>1xN,
- And presence of ≥1 de novo stenosis(es) \>50% located on ≥1 native coronary artery(ies) and successfully treated using percutaneous coronary intervention and stenting.
- Group 2 (Stable coronary artery disease) :
- Documented myocardial ischemia (stable angina or positive stress test)
- And presence of ≥1 de novo stenosis(es) \>50% located on ≥1 native coronary artery(ies) and successfully treated using percutaneous coronary intervention and stenting.
- Group 3 (Normal coronary arteries) :
- No history of coronary artery disease, neurovascular disease or peripheral artery disease,
- And normal coronary angiography performed because of suspected coronary artery disease
- And absence of significant functional or anatomic abnormalities suggestive of atherosclerosis on non-invasive arterial studies (measurements of intima-media thickness, pulse wave velocity, ankle-brachial index, …).
Exclusion
- Group 1 :
- Preexisting EKG abnormalities (including left bundle branch block) precluding accurate assessment of ST-T changes
- Group 2 :
- History of acute coronary syndrome
- Groups 1 and 2:
- Culprit coronary artery stenosis is a restenosis or a stent thrombosis or is located in a bypass graft.
- All groups :
- Heart failure (NYHA class ≥II)
- Left ventricular ejection fraction \<50%
- Severe valvular heart disease requiring surgical or percutaneous therapy
- History of autoimmune, inflammatory or neoplasia diseases ; or infectious disease in the month before admission
- Life expectancy \< 1 year
- Age \<18 years or \>80 years
- Current pregnancy or breast-feeding
- Homeless or travelers who may not be followed-up
- Refusal to sign the informed consent form
Key Trial Info
Start Date :
March 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT00430820
Start Date
March 1 2007
End Date
November 1 2009
Last Update
December 3 2010
Active Locations (1)
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1
Department of Cardiology, Hopital Bichat, APHP
Paris, France, 75018