Role of the Inflammatory Receptors in the Pathogenesis of Atherosclerosis

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by University of Roma La Sapienza
Sponsor:
Information provided by (Responsible Party):
Francesco Pelliccia, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT02062216
First received: February 9, 2014
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

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


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Role of the Inflammatory Receptors in the Pathogenesis of Atherosclerosis

Resource links provided by NLM:


Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • Level of the inflammatory receptors [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Determination of plasmatic level of the inflammatory receptors


Secondary Outcome Measures:
  • C-reactive protein (CPR) [ Time Frame: Up to 24 hours after PCI ] [ Designated as safety issue: No ]
    Changes 24 hours after PCI in C-reactive protein (CPR)

  • Fibrinogen [ Time Frame: Up to 24 hours after PCI ] [ Designated as safety issue: No ]
    Changes 24 hours after PCI in fibrinogen

  • Plasminogen activator inhibitor (PAI-1) [ Time Frame: Up to 24 hours after PCI ] [ Designated as safety issue: No ]
    Changes 24 hours after PCI in Plasminogen activator inhibitor (PAI-1)


Estimated Enrollment: 50
Study Start Date: February 2015
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02062216

Contacts
Contact: Francesco Pelliccia, MD +39064994 ext 123 f.pelliccia@mclink.it

Sponsors and Collaborators
University of Roma La Sapienza
  More Information

No publications provided

Responsible Party: Francesco Pelliccia, Assistant Professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT02062216     History of Changes
Other Study ID Numbers: 81/2014/D
Study First Received: February 9, 2014
Last Updated: March 13, 2014
Health Authority: Italy: National Institute of Health

Keywords provided by University of Roma La Sapienza:
Coronary artery disease
Percutaneous coronary intervention
Inflammatory receptors

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on August 20, 2014