Role of the Inflammatory Receptors in the Pathogenesis of Atherosclerosis

N/AUnknownNCT02062216

University of Roma La Sapienza50 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Coronary Artery Disease

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Level of the inflammatory receptors

Determination of plasmatic level of the inflammatory receptors

Time frame: Baseline

Secondary Outcomes

C-reactive protein (CPR)

Changes 24 hours after PCI in C-reactive protein (CPR)

Time frame: Up to 24 hours after PCI

Fibrinogen

Changes 24 hours after PCI in fibrinogen

Time frame: Up to 24 hours after PCI

Plasminogen activator inhibitor (PAI-1)

Changes 24 hours after PCI in Plasminogen activator inhibitor (PAI-1)

Time frame: Up to 24 hours after PCI

Central Contacts

Francesco Pelliccia, MD

CONTACT

+39064994 f.pelliccia@mclink.it

Data from ClinicalTrials.gov

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