Health Condition 1: I509- Heart failure, unspecified
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Mayacardio Check Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Adults aged 18 years and above able to provide informed consent or legally acceptable representative consent. Participants with left-heart disease including left ventricular dysfunction, left-sided valvular disease, left atrial disease/supraventricular arrhythmia, or chronic coronary artery disease. Participants requiring hemodynamic monitoring in ICU, emergency, peri-operative, or major surgery settings. Participants with cardiovascular or relevant non-cardiovascular comorbidities where cardiovascular risk/hemodynamic monitoring is clinically relevant. Healthy volunteers with no known structural heart disease and no significant exclusion criteria.
Exclusion criteria
Exclusion criteria: Pregnancy. Moderate to severe right-heart failure or pulmonary vascular disease. Significant pulmonary hypertension. Acute pulmonary embolism with right ventricular strain or chronic thromboembolic disease. Moderate to severe tricuspid or pulmonic valve disease. Congenital heart disease or intracardiac shunts. Active implantable electronic devices if interfering with investigational device. Contraindications to study procedures including severe dermatologic conditions at electrode sites. Inability or unwillingness to provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Development and validation of bioimpedance-derived algorithms for estimation of hemodynamic and metabolic parameters including cardiac output, stroke volume, cardiac volumes, ejection fraction, systolic/diastolic timing intervals, myocardial performance index, and body composition measures against reference standards.Timepoint: At baseline during study visit and at each measurement session where applicable. | — |
Secondary
| Measure | Time frame |
|---|---|
| Development and validation of personalized cardiovascular risk prediction model integrating bioimpedance-derived parameters with traditional clinical risk factors.Timepoint: During study analysis after completion of participant enrollment and data aggregation.;Comparison of personalized cardiovascular risk prediction model performance with WHO and Steno cardiovascular risk prediction models.Timepoint: At final data analysis after model development.;Assessment of association between non-traditional risk factors including thoracic fluid overload and visceral adiposity with cardiovascular outcomes.Timepoint: During final statistical analysis after completion of follow-up/data collection. | — |
Countries
India
Contacts
Public ContactDr Chandrabhan Meena
SMS medical college jaipur
Outcome results
None listed