Evaluating the Role of IGF-1 and S-Klotho In Plaque Phenotype and Vulnerability: the VISION Study.

Last updated: December 4, 2024
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Coronary Artery Disease

Thrombosis

Chest Pain

Treatment

Coronary angiography with OCT

Coronarography with OCT

Clinical Study ID

NCT06522074
6347
  • Ages > 18
  • All Genders

Study Summary

Insulin-like growth factor 1 (IGF-1) is the primary peripheral mediator of growth hormone (GH) and has pleiotropic effects on development, differentiation, metabolism, and cell survival. Several in vivo and in vitro studies suggest that IGF-1 may have a protective effect on atherosclerosis as it suppresses macrophage recruitment and activation, cytokine production, and extracellular matrix degradation while promoting smooth muscle cell migration and proliferation and extracellular matrix deposition. The protein sKlotho appears to be closely related to the GH-IGF-1 axis, and some animal and in vitro studies hypothesize its protective role in the cardiovascular system. The GH-IGF-1 axis and sKlotho influence mechanisms determining coronary atherosclerosis. Circulating levels of IGF-1 and sKlotho may correlate with the morphology of atherosclerotic plaques and particularly with the vulnerability of coronary lesions.

Objectives: To evaluate the correlation between atherosclerotic plaque phenotype and the GH-IGF-1 axis and sKlotho in patients with chronic coronary syndrome using intravascular imaging with Optical Coherence Tomography (OCT).

Methods:All patients with chronic coronary syndrome who meet the inclusion and exclusion criteria and undergo coronary angiography and intravascular imaging with optical coherence tomography will be included. At the end of the procedure, a blood sample will be taken to measure IGF-1, sKlotho, and GH receptor (GHR) polymorphism.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with chronic coronary syndrome undergoing coronary angiographic study.

  • Patients undergoing intravascular imaging with OCT during coronary angiographicstudy at the operator's discretion, for diagnostic purposes and/or to guide possiblecoronary artery disease treatment.

  • Patients with at least 18 years of age.

  • Patients able to provide informed consent.

Exclusion

Exclusion Criteria:

  • Pregnancy.

  • Pathological excess or deficiency of IGF-1.

  • Stage IV chronic renal failure.

  • Severe liver disease.

  • Cachexia and/or malnutrition states.

  • BMI <18.5.

  • HbA1C ≥ 8.5%.

  • Left Ventricle Ejection Fraction (LVEF) <= 35%

  • Patients with aorto-coronary bypass.

  • OCT analysis conducted on vessels with previous percutaneous coronary interventionwith stent implantation.

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: Coronary angiography with OCT
Phase:
Study Start date:
October 15, 2024
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Cardiologia

    Roma, 00168
    Italy

    Site Not Available

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