Role of the Inflammatory Receptors in the Pathogenesis of Atherosclerosis

• Conditions: Coronary Artery Disease

• Registration Number: NCT02062216
• Lead Sponsor: University of Roma La Sapienza

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2014-02-09
• Study First Submitted QC: 2014-02-11
• Study First Posted: 2014-02-13
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-13
• Last Update Posted: 2014-03-14
• Study Start: 2015-02
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Level of the inflammatory receptors	Baseline	Determination of plasmatic level of the inflammatory receptors

Secondary Outcome Measures

Name	Time	Method
Fibrinogen	Up to 24 hours after PCI	Changes 24 hours after PCI in fibrinogen
C-reactive protein (CPR)	Up to 24 hours after PCI	Changes 24 hours after PCI in C-reactive protein (CPR)
Plasminogen activator inhibitor (PAI-1)	Up to 24 hours after PCI	Changes 24 hours after PCI in Plasminogen activator inhibitor (PAI-1)