Role of the Inflammatory Receptors in the Pathogenesis of Atherosclerosis

NCT02062216 | Unknown

• 1 other identifier: 81/2014/D
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease; Percutaneous coronary intervention; Inflammatory receptors

Outcome Measures

Primary Outcomes (1)

• Level of the inflammatory receptors

  Determination of plasmatic level of the inflammatory receptors

  Baseline

Secondary Outcomes (3)

• C-reactive protein (CPR)

  Up to 24 hours after PCI

• Fibrinogen

  Up to 24 hours after PCI

• Plasminogen activator inhibitor (PAI-1)

  Up to 24 hours after PCI

Study Arms (2)

STEMI

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

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Roma La Sapienza: lead

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Francesco Pelliccia, MD

CONTACT

+39064994; f.pelliccia@mclink.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 9, 2014
• First Posted: February 13, 2014
• Study Start: February 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: March 14, 2014

Record last verified: 2014-03