Role of the Inflammatory Receptors in the Pathogenesis of Atherosclerosis

Study Overview
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Brief Summary
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The primary objective of this study is to assess whether inflammatory receptors play a role in the pathogenesis of atherosclerosis.

Detailed Description
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Atherosclerosis is a chronic inflammatory disease characterized by lipid deposition and macrophages/foam cell accumulation beneath the arterial intima. Immune competent cells are abundant in atherosclerotic lesions, where they produce mainly proinflammatory cytokines. Macrophages play a central role in each stage of the pathogenesis of atherosclerosis. At the beginning, the so-called foam cells contribute to the formation of early lesions; in mature plaques, macrophages constitute 50% of the cells in the lesion; finally, they are involved in the mechanisms leading to plaque rupture. The primary objective of this study is to assess whether the inflammatory receptors play a role in the pathogenesis of atherosclerosis.

Official Title
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Role of the Inflammatory Receptors in the Pathogenesis of Atherosclerosis

Conditions
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Coronary Artery Disease

Participation Criteria
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Eligibility Criteria
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Study Population 1 Patients with ST-elevation myocardial infarction (STEMI) with angiographic evidence of massive thrombosis in the culprit artery undergoing primary percutaneous coronary intervention (PCI) Criteria Inclusion Criteria: ST-elevation myocardial infarction Angiographic evidence of massive thrombosis in the culprit artery Indication to primary percutaneous coronary intervention (PCI) Able to understand and willing to sign the informed CF Exclusion Criteria: • Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT Study Population 2 Patients with coronary artery disease in stable conditions scheduled to undergo elective percutaneous coronary intervention and patients with Criteria Inclusion Criteria: A de novo native coronary artery lesions (reference vessel diameter:2.5-3.75 mm) Class I indication to elective percutaneous coronary intervention Stable conditions and no recent acute coronary syndromes Normal baseline values of markers of myocardial damage (creatine kinase, creatine kinase-MB, myoglobin, and troponin I) Able to understand and willing to sign the informed CF Exclusion Criteria: • Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| STEMI<br>Patients with ST-elevation myocardial infarction (STEMI) with angiographic evidence of massive thrombosis in the culprit artery undergoing primary percutaneous coronary intervention (PCI) | |
| STABLE ANGINA<br>Patients with coronary artery disease in stable conditions scheduled to undergo elective percutaneous coronary intervention and patients with Class I indication to elective percutaneous coronary intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of the inflammatory receptors | Determination of plasmatic level of the inflammatory receptors | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-reactive protein (CPR) | Changes 24 hours after PCI in C-reactive protein (CPR) | Up to 24 hours after PCI | 
| Fibrinogen | Changes 24 hours after PCI in fibrinogen | Up to 24 hours after PCI | 
| Plasminogen activator inhibitor (PAI-1) | Changes 24 hours after PCI in Plasminogen activator inhibitor (PAI-1) | Up to 24 hours after PCI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary artery disease, Percutaneous coronary intervention, Inflammatory receptors