Role of the Inflammatory Receptors in the Pathogenesis of Atherosclerosis

Coronary Artery Disease Clinical Trial

— Receptors  

Official title:

Role of the Inflammatory Receptors in the Pathogenesis of Atherosclerosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02062216
• Other study ID #: 81/2014/D
• Status: Not yet recruiting
• Phase: N/A
• First received: February 9, 2014
• Last updated: March 13, 2014
• Start date: February 2015
• Est. completion date: December 2018

Study information

• Verified date: March 2014
• Source: University of Roma La Sapienza
• Contact: Francesco Pelliccia, MD
• Phone: +39064994
• Email: f.pelliccia[@]mclink.it
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of the inflammatory receptors	Determination of plasmatic level of the inflammatory receptors	Baseline	No
Secondary	C-reactive protein (CPR)	Changes 24 hours after PCI in C-reactive protein (CPR)	Up to 24 hours after PCI	No
Secondary	Fibrinogen	Changes 24 hours after PCI in fibrinogen	Up to 24 hours after PCI	No
Secondary	Plasminogen activator inhibitor (PAI-1)	Changes 24 hours after PCI in Plasminogen activator inhibitor (PAI-1)	Up to 24 hours after PCI	No