Beyond the Mehran Risk Score: Predictive Value of Total Ischemic Time for Contrast-Induced Nephropathy in ST Segment Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 主要终点
- Incidence of Contrast-Induced Nephropathy (CIN)
研究概览
简要总结
Contrast-Induced Nephropathy (CIN) is a serious complication following primary percutaneous coronary intervention (PCI) in patients presenting with acute ST-segment elevation myocardial infarction (STEMI). While the standard Mehran Risk Score uses static baseline clinical and procedural variables, it lacks dynamic parameters reflecting acute myocardial ischemic duration. Total ischemic time-from symptom onset to balloon inflation-drives systemic inflammation, forward cardiac failure, and renal hypoperfusion.
This prospective observational validation cohort study aims to evaluate the independent predictive value of Total Ischemic Time for CIN in acute STEMI patients undergoing primary PCI. Additionally, it investigates whether integrating total ischemic duration into the classic Mehran Risk Score enhances discrimination accuracy, net reclassification, and calibration performance for early pre-procedural risk stratification.
详细描述
Background:
Contrast-Induced Nephropathy (CIN) remains one of the most significant complications following primary percutaneous coronary intervention (PPCI) in patients presenting with ST-segment elevation myocardial infarction (STEMI). The traditional Mehran Risk Score utilizes static baseline parameters (such as hypotension, IABP, CHF, age, anemia, diabetes, contrast volume, and baseline eGFR) to stratify CIN risk. However, it omits the duration of acute myocardial ischemia. Prolonged total ischemic time (the interval from symptom onset to first balloon inflation/device placement) triggers severe systemic inflammatory cascades, hemodynamic instability, and transient renal hypoperfusion, which may independently increase susceptibility to contrast-induced acute kidney injury.
Objectives:
To evaluate the independent predictive value of Total Ischemic Time for Contrast-Induced Nephropathy (CIN) in acute STEMI patients undergoing primary PCI.
To investigate whether integrating total ischemic duration into the classic Mehran Risk Score enhances its predictive performance, discrimination, calibration, and risk reclassification capacity.
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
- 是
入选标准
- •Inclusion Criteria:
- •Patients aged >=18 years at the time of presentation.
- •Definitive diagnosis of acute ST-segment elevation myocardial infarction (STEMI) presenting within 12 hours of symptom onset, characterized by typical ischemic symptoms (e.g., retrosternal chest pain) and electrocardiographic criteria: persistent ST-segment elevation >=1 mm in >=2 contiguous limb leads, or >=2 mm in >=2 contiguous precordial leads (V2-V3 thresholds: >=2.5 mm in men <40 years, >=2.0 mm in men >=40 years, and >=1.5 mm in women), or a validated new or presumably new left bundle branch block (LBBB).
- •Selection for immediate mechanical reperfusion via emergency primary percutaneous coronary intervention (PPCI) according to current guidelines.
- •A reliable and verifiable chronological timeline regarding the exact onset of chest pain or ischemic symptoms to ensure precise calculation of the total ischemic duration.
- •Willingness to participate, demonstrated by signed, informed consent obtained from the patient or an authorized family representative prior to data collection under approved institutional protocols.
排除标准
- •Pre-existing end-stage renal disease (ESRD) requiring long-term peritoneal dialysis or hemodialysis, or an admission baseline eGFR <15 mL/min/1.73m
- •Prior exposure to iodinated contrast media within the past 7 days, or scheduled elective contrast procedures within the subsequent 72 hours.
- •Intentional pre-procedural administration of structured, high-volume intravenous fluid hydration regimens specifically designed to prevent contrast nephropathy (e.g., sodium bicarbonate protocols), which would confound baseline renal kinetics.
- •Known active treatment with high-potency nephrotoxic drugs within the 48 hours prior to admission (e.g., cisplatin, high-dose aminoglycosides, amphotericin B).
- •Active pregnancy, ongoing breastfeeding, or severe non-cardiac co-morbidities associated with a life expectancy <30 days (e.g., advanced terminal malignancies)
研究组 & 干预措施
STEMI Patients Undergoing Primary PCI
Consecutive adult STEMI patients presenting within 12 hours of symptom onset who undergo primary percutaneous coronary intervention (PPCI). Total ischemic time and baseline serum creatinine are measured, and renal function is monitored at 24, 48, and 72 hours post-PCI to evaluate Contrast-Induced Nephropathy (CIN).
干预措施: Total Ischemic Time Evaluation (Diagnostic Test)
结局指标
主要结局
Incidence of Contrast-Induced Nephropathy (CIN)
时间窗: Up to 72 hours post-procedure
Incidence of CIN, defined as an absolute increase in serum creatinine of ≥ 0.5 mg/dL or a relative increase of ≥ 25% from baseline values measured at 24, 48, and 72 hours following primary PCI.
次要结局
- Serial Variations of Renal Biomarkers and Short-Term Clinical Outcomes(Baseline, 24, 48, and 72 hours post-procedure, up to index hospital discharge (up to 7 days))
研究者
Asmaa talaat
resident of cardiology , assiut universiy
Assiut University