Role of the Inflammatory Receptors in the Pathogenesis of Atherosclerosis

NCT ID: NCT02062216

Last Updated: 2014-03-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2018-12-31

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.

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

STEMI

Patients with ST-elevation myocardial infarction (STEMI) with angiographic evidence of massive thrombosis in the culprit artery undergoing primary percutaneous coronary intervention (PCI)

No interventions assigned to this group

STABLE ANGINA

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

No interventions assigned to this group

Eligibility 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

• 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 Population 2 Patients with coronary artery disease in stable conditions scheduled to undergo elective percutaneous coronary intervention and patients with

Criteria

• Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Francesco Pelliccia

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Francesco Pelliccia, MD

Role: CONTACT

f.pelliccia@mclink.it

+39064994 ext. 123

Other Identifiers

81/2014/D

Identifier Type: -

Identifier Source: org_study_id