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

NCT06522074 | Active Not Recruiting

• 1 other identifier: 6347
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  2 years

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Cardiologia

Roma, 00168, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Coronary Angiography; Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Angiography; Radiography; Diagnostic Techniques, Cardiovascular; Heart Function Tests; Tomography, Optical; Optical Imaging; Tomography; Investigative Techniques

Study Officials

• Francesco Burzotta

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 26, 2024
• Study Start: October 15, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 9, 2024

Record last verified: 2024-07

Locations

IT (1)