Ireland
--:--IST
Active, not recruiting Observational

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

NCT06522074 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2024-10-15
Last updated
2024-12-09

Condition(s) studied

Ischemic Heart DiseaseChronic Coronary SyndromeOptical Coherence Tomography (OCT)

Investigational drug(s) / intervention(s)

Coronary angiography with OCT

Coronary angiography with OCT: Intravascular imaging with Optical Coherence Tomography (OCT) in patients with chronic coronary syndrome who have been indicated for coronary angiographic will be used at the operator's discretion, for diagnostic purposes and/or to guide possible coronary artery disease treatment.

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients with chronic coronary syndrome undergoing coronary angiographic study. * Patients undergoing intravascular imaging with OCT during coronary angiographic study at the operator's discretion, for diagnostic purposes and/or to guide possible coronary artery disease treatment. * Patients with at least 18 years of age. * Patients able to provide informed consent. 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 intervention with stent implantation.

Primary outcome measure(s)

  • Correlation between atherosclerotic plaque phenotype and plasma levels of IGF-1 and sKlotho protein and GH receptor (GHR) polymorphism — 2 years
    To assess the correlation between atherosclerotic plaque phenotype and plasma levels of IGF-1, sKlotho protein, and GH receptor (GHR) gene expression through intravascular imaging with Optical Coherence Tomography (OCT).

Trial sites (1)

FacilityCityRegionStatus
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Cardiologia Roma Italy
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06522074 on ClinicalTrials.gov ↗ ← All trials in Italy