ENDOBARIHEART STUDY

ConditionObesity & Overweight

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorMaria Cecilia Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

informed consent

obesity or overweight

atherosclerotic cardiovascular disease

type 1 or type 2 diabetes mellitus

Disqualifiers

chronic inflammatory diseases

active viral or bacterial infections

severe anaemia or severe coagulopathy

severe chronic kidney failure

Trial design

Design model

Single group

Treatments tested in this trial

echocardiography
Other intervention
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
Coronary CT angiography
Radiation
Coronary CT angiography has a duration of 10-15 minutes per patient and requires the use of contrast
blood analysis
Biological/Vaccine
Blood count, liver and kidney function, coagulation assessment, C-reactive protein, glycaemic and lipidic profile

Treatment groups

50 Participants

are divided into 1 treatment group

Group A: Patients Undergoing Endoscopic Sleeve GastroplastyOther 3 interventions

Trial outcomes

Primary outcomes

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.

Time frame

From enrollment to the end of follow up at 12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Maria Cecilia Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: