Role of the Inflammatory Receptors in the Pathogenesis of Atherosclerosis

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02062216

Acronym

Receptors

Enrollment

Registered

2014-02-13

Start date

2015-02-28

Completion date

2018-12-31

Last updated

2014-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease, Percutaneous coronary intervention, Inflammatory receptors

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
Level of the inflammatory receptors	Baseline	Determination of plasmatic level of the inflammatory receptors

Secondary

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

Contacts

Primary ContactFrancesco Pelliccia, MD

f.pelliccia@mclink.it+39064994

Outcome results