Role of the Inflammatory Receptors in the Pathogenesis of Atherosclerosis

University of Roma La Sapienza

Status: Unknown

Conditions: Coronary Artery Disease

Study type: Observational

Funder types: Other

Identifiers

NCT02062216

81/2014/D

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

50 participants in 2 patient groups

STEMI

Description:

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

Description:

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