Clinical trial NCT06522074: Evaluating the Role of IGF-1 and S-Klotho In Plaque Phenotype and Vulnerability: the VISION Study.
Official title: Evaluating the Role of IGF-1 and S-Klotho in Plaque Phenotype and Vulnerability: The VISION Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Ischemic Heart Disease
Chronic Coronary Syndrome
Optical Coherence Tomography (OCT)
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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 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 outcomes:
measure: Correlation between atherosclerotic plaque phenotype and plasma levels of IGF-1 and sKlotho protein and GH receptor (GHR) polymorphism
timeFrame: 2 years
Secondary outcomes:
measure: correlation between atherosclerotic plaque phenotype and plasma levels of other hormones and inflammation markers
timeFrame: 2 years
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Cardiologia
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Francesco Burzotta
role: PRINCIPAL_INVESTIGATOR
References: