Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: SYNTAX Score II Risk Stratification: Evaluation of predictive outcomes in patients undergoing percutaneous coronary intervention using the SYNTAX Score I
Sponsors
Rhythm Heart and Critical Care
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age: Adults aged 20 years and above. 2. Gender: Both male and female participants. 3. Echocardiographic Readings: Participants with normal echocardiographic parameters based on existing clinical records. 4. Medical History: No history of diabetes, hypertension, or any cardiac illness. No history of significant systemic diseases or malignancies. 5. Body Composition: Participants with body surface area (BSA)-indexed echocardiographic measurements within normal ranges. 6. Regional Representation: Data will be drawn from participants across various regions to ensure national representation.
Exclusion criteria
Exclusion criteria: 1. Pre-existing Cardiac Conditions:Participants with structural heart abnormalities (e.g., congenital or acquired). Any prior diagnosis of heart disease (including ischemic heart disease, cardiomyopathies, or valvular heart diseases). 2. Systemic Illnesses: Participants with a history of systemic diseases (e.g., autoimmune diseases, cancer) or malignancy. 3. Pregnancy and Lactation:o Pregnant and lactating mothers will be excluded due to potential physiological changes in cardiac dimensions during these conditions. 4. Lifestyle Factors: Smokers (both current and former, if smoking has significantly affected cardiac health). Chronic alcoholics (participants with a history of heavy alcohol consumption). 5. Athletes: Athletes involved in regular intensive training will be excluded due to potential alterations in cardiac dimensions caused by athletic conditioning. 6. Abnormal Cardiac Dimensions: Participants with any deviation from normal cardiac dimensions detected through pre-existing echocardiographic data will be excluded to maintain the integrity of the normal dataset. 7. Incomplete Medical Records: Participants with incomplete or missing echocardiographic data or essential clinical information will not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome: To evaluate the predictive accuracy of the SYNTAX Score II for identifying the risk of adverse cardiovascular events, including major adverse cardiovascular events (MACE), such as death, myocardial infarction, and repeat revascularization, within a specified follow-up period. Outcome Metrics: MACE rate (measured as a composite endpoint). Survival rates post-percutaneous coronary intervention (PCI). Event-free survival rates for predefined adverse outcomes.Timepoint: One Week from beginning of trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Compare SYNTAX Score II with other risk tools, assess long-term outcomes (mortality, revascularization), evaluate procedural success, complications, & subgroup analyses by demographics & comorbidities.Timepoint: One week after the trial begins | — |
Countries
India
Contacts
Public ContactHarshawardhan Dhanraj Ramteke
Rhythm Heart and Critical Care
Outcome results
None listed