跳至主要内容
临床试验/CTRI/2023/08/056317
CTRI/2023/08/056317尚未招募2 期

Comparison of routine vascular bed preparation versus need based vascular bed preparation in patients undergoing primary PCI

VMMC and Safdurjung Hospital1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2023年1月9日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
135
试验地点
1
主要终点
1 To compare the efficacy in terms of TIMI flow grade, TIMI frame count, TMP grade of routine vascular bed preparation versus need based vascular bed preparation in patients undergoing primary PCI

研究概览

简要总结

Primary percutaneous coronary intervention (PCI) is one of the most effective treatments for acute ST-segment elevation myocardial infarction (STEMI). However, despite the presence of normal epicardial flow, post-procedural microvascular obstruction (MVO) which substantially reduces the beneficial effects of PCI, remains an important limitation of the procedure.Since presence of no-reflow is related to higher risk of major adverse cardiac events (MACE) due to the poor healing of the infarct, adverse left ventricular remodeling, congestive heart failure occurrence and death. There is paucity of data with respect to vascular bed preparation prior to primary PCI in patients with STEMI. Currently, there is still a lack of an optimal treatment for no-reflow phenomenon. Prevention can be effective to reduce no-reflow occurrence with medical therapy. Hence, various strategies to prevent no reflow like vascular bed preparation prior to primary PCI can be beneficial, as our aim of revascularization is to improve coronary blood flow at the level of microcirculation to reduce myocardial damage and improve clinical outcome. Various centers are practicing vascular bed preparation prior to primary PCI, in our hospital also both (intracoronary vasodilator via guiding catheter followed by primary PCI and targeted intracoronary delivery of vasodilator followed by primary PCI) methods of vascular bed preparation is being practiced. There is no standard guideline at present for the various methods of intracoronary therapies prior to primary PCI. Therefore, this study is designed with the aim of role of various methods of vascular bed preparation prior to primary PCI.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients with STEMI (undergoing primary PCI) as per the Fourth Universal Definition of Myocardial Infarction Criteria will be recruited.

排除标准

  • Presence of cardiogenic shock (Killip class IV) 2) Severe hypertension (BP> 180/110 mmHg) without control 3) Severe multiple organ failure 4) A recent history of CABG 5) A clinical diagnosis of aortic dissection.

结局指标

主要结局

1 To compare the efficacy in terms of TIMI flow grade, TIMI frame count, TMP grade of routine vascular bed preparation versus need based vascular bed preparation in patients undergoing primary PCI

时间窗: At baseline and 30 day

2 To compare the in hospital & 30-day MACEs (major adverse cardiac events) in patients undergoing primary PCI in routine vascular bed preparation versus need based vascular bed preparation

时间窗: At baseline and 30 day

3 To compare proximal & distal delivery of vasodilators in patients undergoing routine vascular bed preparation

时间窗: At baseline and 30 day

次要结局

  • 1 To compare the in hospital & 30-day MACEs (major adverse cardiac events) in patients undergoing primary percutaneous coronary intervention in routine vascular bed preparation versus need based vascular bed preparation(2 To compare proximal & distal delivery of vasodilators in patients undergoing routine vascular bed preparation)

研究者

发起方
VMMC and Safdurjung Hospital
申办方类型
Government medical college

研究点 (1)

Loading locations...

相似试验