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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-15

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ischemic Heart Disease Chronic Coronary Syndrome Optical Coherence Tomography (OCT)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francesco Burzotta

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Locations

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Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Cardiologia

Roma, , Italy

Site Status

Countries

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Italy

Other Identifiers

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6347

Identifier Type: -

Identifier Source: org_study_id