NCT06522074Active, not recruiting
Evaluating the Role of IGF-1 and S-Klotho In Plaque Phenotype and Vulnerability: the VISION Study.
Evaluating the Role of IGF-1 and S-Klotho in Plaque Phenotype and Vulnerability: The VISION Study
Source: ClinicalTrials.gov · Last updated 9 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 22 Jul 2024
- Start date
- 15 Oct 2024
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Coronary artery disease
- NCT number
- NCT06522074
What you commit to
- Study type: Observational
- Planned participants: 150
- From 15 Oct 2024 to the primary completion date, 30 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- OCT analysis conducted on vessels with previous percutaneous coronary intervention with stent implantation.
Other illness
- Stage IV chronic renal failure.
- Severe liver disease.
Lab values
- HbA1C ≥ 8.5%.
- Left Ventricle Ejection Fraction (LVEF) \<= 35%
Other
- Pregnancy.
- Pathological excess or deficiency of IGF-1.
- Cachexia and/or malnutrition states.
- BMI \<18.5.
- Patients with aorto-coronary bypass.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Cardiologia Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.