Comparison of the Treatment Efficacy of Rosuvastatin Versus Atorvastatin Loading Prior to Percutaneous Coronary Intervention in ST-Segment Elevation Myocardial Infarction
试验速览
- 阶段
- 不适用
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- angiographic parameters
研究概览
简要总结
To compare the effect of a single high dose of atorvastatin versus rosuvastatin preloading on microvascular coronary perfusion as determined by CTFC in patients with ST-segment elevation myocardial infarction (STEMI) undergoing PCI.
详细描述
Acute myocardial infarction (MI) indicates irreversible myocardial injury resulting in necrosis of a significant portion of myocardium which is caused mostly by coronary plaque rupture or erosion. It could result in several clinical complications and impact cardiac prognosis .
Worldwide, ischemic heart disease is the single most common cause of death and its frequency is increasing, now Accounts for almost 1.8 million annual deaths.
Cholesterol reduction with HMG-CoA (3-hydroxy-3-methylglutaryl coenzyme A) reductase inhibitors or statins has been shown to improve mortality and cardiovascular morbidity in patients with established coronary artery disease (CAD).
Previous evidence suggests that statins have various favorable effects on vascular system that are not directly related to their impact on lipid metabolism. Beyond lowering lipids, statins have favorable effects on platelet adhesion, thrombosis, endothelial function, plaque stability, and inflammation. . As with ACS, the vascular injury from coronary angioplasty and stent placement induces platelet activation, thrombosis, and inflammation within the vessel wall and the distal microvasculature. Therefore, in addition to a long-term benefit associated with lipid lowering, statin therapy might play a beneficial role early after PCI.
Conventional TIMI flow grading (Thrombolysis In Myocardial Infarction) is a predictor of cardiac outcome after acute myocardial infarction and PCI, but it has several limitations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The Presence of symptoms (<12h).
- •ST-segment elevation of at least 0.1Mv in two contiguous leads of electrocardiogram or new onset left bundle branch block.
- •Patients age 18 to 80 years.
排除标准
- •Previous (within 3 months) or current treatment with statins.
- •Known allergy to heparin, aspirin, clopidogrel, or abciximab.
- •Active severe bleeding.
- •Pregnancy.
- •History of major surgery or trauma.
- •Significant gastrointestinal or genitourinary bleeding (<6 weeks).
- •History of cerebrovascular attack (within 2 years) or cerebrovascular attack with a significant residual neurological deficit.
- •Cardiogenic shock with mechanical ventilation.
研究组 & 干预措施
control group
in this group patients will not receive statin before primary PCI
干预措施: Control Test (Drug)
atorvastatin group
in this group patients will receive 80 mg atorvastatin single dose before primary PCI
干预措施: Atorvastatin 80mg (Drug)
rosuvastatin group
in this group patients will receive 40 mg rosuvastatin single dose before primary PCI
干预措施: Rosuvastatin 40mg (Drug)
结局指标
主要结局
angiographic parameters
时间窗: 3 months
CTFC (corrected TIMI frame count) In the CTFC method, the number of frames required for dye to reach a standardized distal landmark is counted. A correction factor is required to compensate for the longer length of the left anterior descending artery (LAD) compared with the circumflex and right coronary arteries (the number of frames required for dye to traverse the LAD is divided by 1.7). The frame count number after adjustment for vessel length is given the term 'corrected TIMI frame count'.
STR (ST-segment resolution) (STR)
时间窗: 3 months
ST-segment resolution (STR) was calculated as the sum of ST-segment elevation on initial ECG minus the sum of ST-segment elevation on the ECG at 90 min after PCI, divided by the sum of ST- segment elevation on initial ECG, and was expressed as a percentage . The complete early STR was defined as more than or equal to 70% STR.
次要结局
未报告次要终点
研究者
Esraa M. Adel
Principal Investigator
Beni-Suef University