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NCT Number: NCT06522074

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Cardiologia

Roma, 00168, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Coronary angiography with OCT

Diagnostic Test

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.

Primary outcomes

  1. Correlation between atherosclerotic plaque phenotype and plasma levels of IGF-1 and sKlotho protein and GH receptor (GHR) polymorphism

    Time frame: 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).

Secondary outcomes

  1. correlation between atherosclerotic plaque phenotype and plasma levels of other hormones and inflammation markers

    Time frame: 2 years

    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).

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: VISION

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 26, 2024
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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