Prognostic Impact of Guideline-recommended Timing for Invasive Strategy in NSTEMI: a Prospective Real-world Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 407
- 试验地点
- 1
- 主要终点
- Describe the predictive value of the timing of invasive coronary angiography on a composite criteria of overall mortality, recurrent myocardial infarction, stroke, hospitalization for heart failure at 6 months
研究概览
简要总结
The objective of this multicentric observational study is to evaluate the prognostic influence of adherence or non-adherence to the recommended coronary angiography timeframe (within 24 hours) and the six-month prognosis of the patients.
详细描述
Primary Objective: To describe the predictive values (sensitivity and specificity) of the timing of coronary angiography after the diagnosis of NSTEMI.
Secondary Objective: To evaluate an optimal threshold for the timing of coronary angiography that predicts poor prognosis at 6 months (Composite MACCE criterion including all-cause death, recurrent myocardial infarction, hospitalization for cardiac reasons, stroke) (MACCE = Major Adverse Cardiac and Cerebral Events, stroke = cerebrovascular accident).
Comparisons:
Comparison of severe events at 6 months (Composite MACCE criterion including all-cause death, recurrent myocardial infarction, hospitalization for cardiac reasons, stroke) based on the timing of coronary angiography after the diagnosis of NSTEMI according to recommendations (within 24 hours vs. more than 24 hours).
Comparison of severe events at 6 months (all-cause death, recurrent myocardial infarction, hospitalization for cardiac reasons, stroke, considered separately) based on the timing of coronary angiography after the diagnosis of NSTEMI according to recommendations (within 24 hours vs. more than 24 hours).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of chest pain with or without ECG changes
- •Elevation of troponin level > 90th percentile or a significant increase between two dosages
- •Significant or non-significant coronary lesion confirming the diagnosis of coronary artery disease on coronary angiography (coronary angiography mandatory before inclusion to confirm NSTEMI)
排除标准
- •STEMI (ST-segment elevation myocardial infarction) or equivalent (defined as chest pain with ECG changes and troponin elevation > 5 times the normal with an occluded artery (TIMI 0, 1, or 2) during initial coronary angiography)
- •Very high-risk NSTEMI (hemodynamic instability, cardiogenic shock, recurrent/refractory chest pain despite optimal medical treatment, life-threatening arrhythmia, mechanical complication, heart failure clearly related to NSTEMI, ST depression > 1mm/6 leads with ST elevation in aVR and/or V1) for which urgent coronary angiography is mandatory
- •Unstable angina (acute coronary syndrome without troponin elevation)
- •Troponin elevation without chest pain or symptoms suggestive of NSTEMI
- •Recovered cardiac arrest
- •Contraindication to coronary revascularization or coronary angiography
- •Other diagnoses considered after coronary angiography (e.g., myocarditis, Takotsubo syndrome)
- •Age < 18 years
结局指标
主要结局
Describe the predictive value of the timing of invasive coronary angiography on a composite criteria of overall mortality, recurrent myocardial infarction, stroke, hospitalization for heart failure at 6 months
时间窗: From enrollment to 6 months
Sensibility and specificity, positive and negative predictive values
次要结局
- Evaluation of the optimal timing of invasive coronary angiography predicting a negative outcome at 6 months(From enrollment to 6 months)
- Comparison of the composite criteria of an invasive coronary angiography within 24h and after 24h at 6 months(From enrollment to 6 months)
- Comparison of the composite criteria of an invasive coronary angiography within 24h and after 24h at 1 month(From enrollment to 1 month)
- Comparison of each element of the composite criteria individually at 6 months of an invasive coronary angiography within 24h and after 24h(From enrollment to 6 months)
- Describe the prevalence of patients receiving an invasive in respect to the timing of the guidelines(At enrollment)
- Comparison of major bleeding at 6 months(From enrollment to 6 months)
- Length of in-patient stay(6 months)