Predictive Risk Evaluation in Coronary Intervention and Syntax Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Primary Outcome:
研究概览
简要总结
The PRECISION Trial is an observational study aimed at evaluating the predictive value of the SYNTAX Score II for assessing cardiovascular risk in patients undergoing percutaneous coronary intervention (PCI). The study will analyze retrospective data to predict major adverse cardiovascular events (MACE), including death, myocardial infarction, and repeat revascularization. Secondary outcomes include comparisons with other risk stratification tools, procedural success, long-term prognosis, and subgroup analyses by demographics and comorbidities. The expected sample size is 700 patients, with data collected from 2021–2024.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20.00 Year(s) 至 90.00 Year(s)（—）
入选标准
- •Age: Adults aged 20 years and above.
- •Gender: Both male and female participants.
- •Echocardiographic Readings: Participants with normal echocardiographic parameters based on existing clinical records.
- •Medical History: No history of diabetes, hypertension, or any cardiac illness.
- •No history of significant systemic diseases or malignancies.
- •Regional Representation: Data will be drawn from participants across various regions to ensure national representation.
排除标准
- •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).
- •Systemic Illnesses: Participants with a history of systemic diseases (e.g., autoimmune diseases, cancer) or malignancy.
- •Pregnancy and Lactation:o Pregnant and lactating mothers will be excluded due to potential physiological changes in cardiac dimensions during these conditions.
- •Lifestyle Factors: Smokers (both current and former, if smoking has significantly affected cardiac health).
- •Chronic alcoholics (participants with a history of heavy alcohol consumption).
- •Athletes: Athletes involved in regular intensive training will be excluded due to potential alterations in cardiac dimensions caused by athletic conditioning.
- •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.
- •Incomplete Medical Records: Participants with incomplete or missing echocardiographic data or essential clinical information will not be included.
结局指标
主要结局
Primary Outcome:
时间窗: One Week from beginning of trial
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.
时间窗: One Week from beginning of trial
Outcome Metrics:
时间窗: One Week from beginning of trial
MACE rate (measured as a composite endpoint).
时间窗: One Week from beginning of trial
Survival rates post-percutaneous coronary intervention (PCI).
时间窗: One Week from beginning of trial
Event-free survival rates for predefined adverse outcomes.
时间窗: One Week from beginning of trial
次要结局
- Compare SYNTAX Score II with other risk tools, assess long-term outcomes (mortality, revascularization), evaluate procedural success, complications, & subgroup analyses by demographics & comorbidities.(One week after the trial begins)
研究者
Dr. Manish Juneja
Rhythm Heart and Critical Care