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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Ischemic Heart Disease; Chronic Coronary Syndrome; Optical Coherence Tomography (OCT)
• Intervention / Treatment: Diagnostic test: Coronary angiography with OCT

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy, 00168
    • Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Cardiologia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study will include patients with chronic coronary syndrome indicated for coronary angiographic study and who will undergo intravascular imaging with OCT, used at the operator's discretion, for diagnostic purposes and/or to guide possible coronary artery disease treatment.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between atherosclerotic plaque phenotype and plasma levels of IGF-1 and sKlotho protein and GH receptor (GHR) polymorphism	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).	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
correlation between atherosclerotic plaque phenotype and plasma levels of other hormones and inflammation markers	To assess the correlation between atherosclerotic plaque phenotype and plasma levels of thyroid-stimulating hormone (TSH), triiodothyronine (FT3), thyroxine (FT4), cortisol, adrenocorticotropic hormone (ACTH), follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol, testosterone, inflammation markers (interleukin 6, C-reactive protein), vitamin D, and FGF-23 (fibroblast growth factor).	2 years

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Francesco Burzotta, Fondazione Policlinico Universitario A. gemelli, IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 22, 2024
• First Submitted That Met QC Criteria: July 25, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Estimated): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia
• Other Study ID Numbers: 6347

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No