Clinical trial NCT02062216: Role of the Inflammatory Receptors in the Pathogenesis of Atherosclerosis
Official title: Role of the Inflammatory Receptors in the Pathogenesis of Atherosclerosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease
Percutaneous coronary intervention
Inflammatory receptors
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2014-02-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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)

Study Population 2 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

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.

Eligibility 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

Primary outcomes:
measure: Level of the inflammatory receptors
timeFrame: Baseline
Secondary outcomes:
measure: C-reactive protein (CPR)
timeFrame: Up to 24 hours after PCI
measure: Fibrinogen
timeFrame: Up to 24 hours after PCI
measure: Plasminogen activator inhibitor (PAI-1)
timeFrame: Up to 24 hours after PCI
Other outcomes:
Locations:
Study officials:
References: