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NCT07847307
ENDOBARIHEART STUDY
Conditions: Obesity & Overweight
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: Maria Cecilia Hospital
Location: Maria Cecilia Hospital Cotignola Ravenna
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07847307). StuddyBuddy aggregates publicly available trial information.
