Upfront Premedication For Reduction of Microvascular Obstruction and No-reflow in Treating ST-segment Elevation Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 626
- 主要终点
- Efficacy endpoint: Reducing rates of suboptimal PCI results
研究概览
简要总结
Angiographic no-reflow during primary PCI procedures occurs at relatively high rate (25%) and is associated with worsening of long term morbidity and mortality. The exact mechanism of no-reflow is not fully understood, yet it is believed to be multifactorial including microvascular plugging with activated platelets and thrombotic debris in addition to the microvascular dysfunction from the ischaemia-reperfusion injury.
Despite a theoretical advantage of glycoprotein IIb/IIIa inhibitors (GPi) (like; Tirofiban) to suppress the intense platelets' activation/reaction; their use did not lead to a significant net benefit, because it was opposed by increased risk of bleeding.
However, the bleeding that plagued GPi use was predominantly related to vascular access in the era femoral approach was the default. Moreover, there are some recent data suggesting that small intracoronary bolus of GPi was non-inferior to intravenous bolus-infusion dose with less bleeding events.
This study plans to assess upfront premedication with small doses of GPi + Nitroglycerin ± Verapamil, with staged restoration of flow (repeated balloon inflation) to reduce angiographic no-reflow and CMR assessed microvascular occlusion (MVO).
详细描述
A. Study Design This study will be a randomized single blinded prospective study including acute STEMI patients presenting to Aswan heart centre catheterization-lab for pPCI. All patients will undergo pPCI according to the current practice guidelines[1,2] and the local hospital policy in managing STEMI patients.
B. Study Population Acute STEMI patients presenting for pPCI reperfusion (or recuse PCI), identified upon initial wiring of the IRA to have large thrombus burden (TIMI thrombus grade 4-5).
C. Study Site This study with all planned diagnostic and therapeutic protocol will be performed in Aswan Heart Centre, Magdi Yacoub Foundation.
D. Study Protocol
- Patients identified to have large thrombus burden (TIMI-thrombus grade 4 and 5), will be assigned into one of two groups according to a closed envelope randomization system.
- Group A (active arm);
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •STEMI patients with time from symptom onset of < 24 hours duration.
- •Large thrombus burden confirmed after initial wiring.
- •Radial vascular access.
排除标准
- •STEMI patients receiving successful fibrinolytic therapy.
- •TIMI flow ≥ 1 or TIMI thrombus grade ≤ 3 at initial wiring.
- •Refusal to participate int the study, or unable to be consented (unconscious or comatose patients).
- •Femoral access.
- •Previous infarction in the same territory.
- •Patients receiving PTCA only for acute reperfusion and planned for CABG.
- •Patients with known intolerance or contraindications for CMR, such as claustrophobic or those with mechanical heart valve prothesis, or implantable non-conditional heart rhythm devices.
结局指标
主要结局
Efficacy endpoint: Reducing rates of suboptimal PCI results
时间窗: One day (assessed by the end of the procedure)
Sub-optimal PCI results defined as any of: 1. Final TIMI flow \< 3, TIMI myocardial blush grade \< 3, corrected TIMI flow count (cTFC) \< 20, 2. Occurrence of TIMI flow \< 3 during stenting/post dilation, (no reflow) 3. ST elevation resolution \< 50% in the index lead assessed within 30m from the procedural end.
Safety endpoint: Occurrence of intrahospital BARC types 3 or 5 bleedings
时间窗: 30 days
Occurrence of intrahospital BARC types 3 or 5 bleedings
次要结局
- Final TIMI flow(one day (assessed by the end of the procedure))
- NT-BNP at 90 days(90 days)
- Myocardial salvage assessed by CMR(90 days)
- Final TIMI myocardial blush grade(One day (assessed by the end of the procedure))
- LVEF at 90 days(90 days)
- Adverse remodeling of the LV(90 days)
- Occurrence of slow flow/no reflow after stent deployment or stent optimization (TIMI flow < 3)(one day (assessed by the end of the procedure))
- MVO at 90 days assessed by CMR(90 days)