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临床试验/NCT05647018
NCT05647018尚未招募2 期

In-hospital Clinical Outcome of Deferred Stenting Versus Immediate Stenting in the Management of Acute STEMI Presenting With High Thrombus Burden: A Randomized Control Study

Assiut University0 个研究点目标入组 440 人开始时间: 2022年12月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
尚未招募
入组人数
440
主要终点
Effectiveness of the method used in terms of TIMI flow

研究概览

简要总结

To compare the in hospital clinical outcomes in terms of efficacy and safety of deferred stenting versus non-deferred stenting in STEMI patients with high thrombus burden undergoing primary percutaneous intervention.

详细描述

Angiographically, intracoronary thrombus is defined as the presence of a filling defect with reduced contrast density or haziness. Angiographic evidence of thrombus can be seen in 91.6% of patients who present with STEMI(1). Large intracoronary thrombus has an incidence of 16.4% of patients with acute coronary syndrome (ACS).

Thrombus encountered in the setting of ACS has been correlated with acute complications during percutaneous coronary interventions including: 3 times higher MACE - ischemic complications, lower procedural success, higher distal embolization leading to slow/no flow, high mortality, ST elevation and longer hospital stays.

High thrombus burden can be defined using Yip's criteria:

  1. Large infarct-related artery (visually estimated reference vessel diameter ≥ 4 mm)
  2. Angiographic thrombus with the greatest linear dimension > 3 times the reference vessel diameter;
  3. "Cutoff pattern" (lesion morphology with an abrupt cutoff without taper before the occlusion);
  4. Accumulated thrombus (> 5 mm of linear dimension) proximal to the occlusion;
  5. Floating thrombus proximal to the occlusion;
  6. Persistent dye stasis distal to the obstruction. IF more than two criteria indicate the presence of very high thrombus burden.

PCI Strategies introduced in HIGH thrombus BURDEN include incorporation of both pharmacological and mechanical thrombus removal.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •TIMI 2-3 flow in the infarct related artery (IRA) with high thrombus burden at initial angiography.
  • •TIMI 2-3 in the IRA with high thrombus burden after MIMI.

排除标准

  • •TIMI 0-1 flow in the IRA after MIMI.
  • •TIMI 2-3 in the IRA with low thrombus burden.
  • •Contraindication or hypersensitivity to Tirofiban
  • •High bleeding risk calculated using the CRUSADE score >50.

研究组 & 干预措施

Deferred stenting in STEMI patients with high thrombus burden undergoing primary PCI

Active Comparator

干预措施: Primary Percutaneous coronary angiography (Procedure)

Non-deferred stenting in STEMI patients with high thrombus burden undergoing primary PCI

Active Comparator

干预措施: Primary Percutaneous coronary angiography (Procedure)

结局指标

主要结局

Effectiveness of the method used in terms of TIMI flow

时间窗: During in hospital stay up to 36 hours

By TIMI III flow finding

Effectiveness of the method used in regards to ECG.

时间窗: During in hospital stay up to 36 hours

ECG: ST segment resolution immediately after PCI and 90 minutes after PCI

Effectiveness of the method used in regards to development of heart failure.

时间窗: During in hospital stay up to 36 hours

Development of acute heart failure after PCI during hospital admission.

Effectiveness of the method used in regards to mortality.

时间窗: During in hospital stay up to 36 hours

Death during hospital stay post-PCI.

Safety of the method used in regards to bleeding.

时间窗: During in hospital stay up to 36 hours

Bleeding events will be noted and classified according to BARC (Bleeding Academic Research Consortium) bleeding score during hospital stay post-PCI

Safety of the method used in regard to development of arrhythmia.

时间窗: During in hospital stay up to 36 hours

Development of arrhythmia post-PCI will be noted and the type of arrhythmia will be identified.

次要结局

  • Follow up post-PCI by trans-thoracic Echo(During in hospital stay up to 36 hours)
  • Follow up post-PCI in regards to MACE (Major adverse cardiac events)(3 and 6 months after procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yomna Mahmoud Shokry Abdelrehim

Resident doctor

Assiut University

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