Comparative effect of Intracoronary Tirofiban versus Nitroglycerin on Index of Microcirculatory Resistance in patients undergoing primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
研究概览
简要总结
The primary purpose of this study is to compare the effectiveness of two different intracoronary medications—Tirofiban (a glycoprotein IIb/IIIa inhibitor) and Nitroglycerin (a vasodilator)—in treating Microvascular Obstruction (MVO) in patients who have undergone successful primary Percutaneous Coronary Intervention (PCI) for a STEMI (heart attack).While PCI restores blood flow in the large "epicardial" arteries, the small "microvascular" vessels often remain blocked, leading to worse patient outcomes. This study uses the Index of Microcirculatory Resistance (IMR), an invasive real-time measurement, to quantify this obstruction and determine which drug better improves microvascular blood flow. Additionally, the study seeks to use Intravascular Ultrasound (IVUS) to identify specific plaque characteristics that might predict which patients are at high risk for developing MVO.
The study operates under the primary hypothesis that intracoronary Tirofiban will be more effective than intracoronary Nitroglycerin in reducing the Index of Microcirculatory Resistance (IMR) in STEMI patients who exhibit significant microvascular dysfunction (defined as an IMR >31 units) following successful reopening of the main blocked artery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult men and women aged over 18 yr and less than 75 yr who present with STEMI within 12 hours of symptom onset and are hemodynamically stable.
- •Patients will be eligible if they have symptoms consistent with myocardial ischemia (chest pain, dyspnea) for at least 20 minutes accompanied by definite ECG changes indicating STEMI as defined by ACC/AHA guidelines.
- •Successful reperfusion of infarct-related artery with restoration of epicardial flow.
- •Willing and able to comply with all study requirements, including treatment, assessment, and clinic visit attendances.
排除标准
- •Previous MI/PCI/coronary bypass grafting (CABG) in the culprit vessel.
- •Other distal residual lesions with more than 50 percent diameter stenosis in the culprit vessel.
- •Presence of contraindications to study drugs.
- •Presence of contraindications to adenosine infusion for IMR measurement, including sinus node disease, moderate to severe bronchospastic disease, and second or third-degree atrioventricular (AV) block
- •Active malignancy
- •Concurrent illness, including severe infection that may jeopardize the ability of the patient to undergo the procedures outlined in this protocol, with reasonable safety
- •Serious medical or psychiatric conditions
- •Pregnancy or lactation (At time of PCI)
- •Patients who received GpIIb/IIIa treatment prior to IMR measurement.
- •Patients who do not undergo primary PCI due to the lack of severity of the culprit lesion or other reasons, like cardiogenic shock requiring mechanical circulatory support.
研究者
Deepanshu
Govt. Medical College and Hospital, Sector 32, Chandigarh