Ischemic Heart DiseaseVISIONNCT06522074
Evaluating the Role of IGF-1 and S-Klotho In Plaque Phenotype and Vulnerability: the VISION Study.
An observational study of Ischemic Heart Disease and Chronic Coronary Syndrome, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease, Chronic Coronary Syndrome, Optical Coherence Tomography (OCT)
- What is being tested?
- Coronary angiography with OCT
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 15 Oct 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Pregnancy.
- Pathological excess or deficiency of IGF-1.
- Stage IV chronic renal failure.
- Severe liver disease.
- Cachexia and/or malnutrition states.
- BMI <18.5.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Cardiologia
Roma, 00168
About this study
Official title: 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.
- Being tested
- Coronary angiography with OCT
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary angiography with OCTDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 years
Secondary outcomes (1)
correlation between atherosclerotic plaque phenotype and plasma levels of other hormones and inflammation markers
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).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start15 Oct 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesco Burzotta, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522074
- Sponsor's protocol ID
- 6347
- Acronym
- VISION
- Status last verified
- Jul 2024
- First submitted
- 22 Jul 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Role of IGF-1 and S-Klotho in Plaque Phenotype and Vulnerability: The VISION Study
- ClinicalTrials.gov ID
- NCT06522074
- Acronym / sponsor ID
- VISION / 6347
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- Pregnancy.
- Pathological excess or deficiency of IGF-1.
- Stage IV chronic renal failure.
- Severe liver disease.
- Cachexia and/or malnutrition states.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary angiography with OCTIntravascular 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. | Diagnostic test | – |
Primary outcome
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).
1 secondary outcome
correlation between atherosclerotic plaque phenotype and plasma levels of other hormones and inflammation markers
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Burzotta principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Heart Disease and Chronic Coronary Syndrome, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between atherosclerotic plaque phenotype and plasma levels of IGF-1 and sKlotho protein and GH receptor (GHR) polymorphism (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.