Obesity & Overweight
Conditions
Keywords
Cardiovascular Risk, Cardiovascular Risk Factors, Endoscopic Sleeve Gastroplasty, Obesity
Brief summary
The primary outcome of this study is to evaluate changes in cardiovascular risk after endoscopic sleeve gastroplasty (ESG) in patients at high cardiovascular risk, using the SCORE2 ( Systematic COronary Risk Evaluation 2) and SCORE2-OP ( Systematic COronary Risk Evaluation 2 Older Persons) risk scores, which estimate the risk of having a cardiovascular event.
Detailed description
This study aims to evaluate whether endoscopic sleeve gastroplasty (ESG), a minimally invasive procedure that reduces the size of the stomach, may improve cardiovascular health in patients with a high risk of cardiovascular disease. Cardiovascular risk refers to the likelihood of developing serious conditions such as heart attack or stroke. In this study, cardiovascular risk will be assessed using two validated risk scores: SCORE2 (Systematic COronary Risk Evaluation 2), used mainly in adults aged 40-69 years, and SCORE2-OP (Systematic COronary Risk Evaluation 2 - Older Persons), used in people aged 70 years and older. Risk modifiers include coronary calcium score (CAC), coronary angiography and the socioeconomic status, as well as the presence of specific comorbidities. Following recent scientific evidence, circulating biomarkers as well as imaging biomarkers like epicardial fat (EAT) characterization, the quantification of oxidative stress and the composition and role of gut microbiota are proposed to stratify and personalize the calculation of Cardiovascular risk (CV) and therefore improve CV prognosis
Interventions
OTHERechocardiography
Echocardiography will be performed in each patient The following parameters will be assessed: systolic function, diastolic function, presence/absence of ventricular hypertrophy, left atrial volume indexed (LAVi), left atrial strain (LAS), valvular morphology and function, estimated intracardiac pressures
RADIATIONCoronary CT angiography
Coronary CT angiography has a duration of 10-15 minutes per patient and requires the use of contrast
BIOLOGICALblood analysis
Blood count, liver and kidney function, coagulation assessment, C-reactive protein, glycaemic and lipidic profile
Sponsors
Maria Cecilia Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* informed consent * obesity or overweight * atherosclerotic cardiovascular disease * type 1 or type 2 diabetes mellitus * hypercholesterolemia or severe dyslipidemia * evidence of subclinical atherosclerosis
Exclusion criteria
* chronic inflammatory diseases * active viral or bacterial infections * severe anaemia or severe coagulopathy * severe chronic kidney failure * active malignancy * anticoagulant therapy * chronic treatment with immunosuppressants/immunomodulators * pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Systematic Coronary Risk Evaluation 2 ( SCORE 2) and Systematic Coronary Risk Evaluation 2 Older Persons (SCORE 2 OP) using algorithms after endoscopic sleeve gastroplasty. | From enrollment to the end of follow up at 12 months |
Countries
Italy
Contacts
CONTACTElisa Giacomini, PhD
Outcome results
None listed