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临床试验/NCT03383393
NCT03383393Unknown不适用

Pharmacologic Treatment of Myocardial Ischemia Detected by Intracoronary ECG

Alexandrovska University Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年1月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Intracoronary ischemia change after intracoronary drug bolus

研究概览

简要总结

After PCI searching for target lesion ischemia with intracoronary ECG will be performed and if found it will be treated pharmacologically

详细描述

The study will include patients with coronary lesions and PCI. It will include patients with stable or unstable angina, without elevated hs-TnT. PCI will be performed and monitoring of intracoronary ST elevation. Any dissection or acute vessel closure will be promptly treated with balloon or stenting.

Although there could be good angiographic result sometimes ischemia could be detected in the treated region by means of intracoronary ECG ST elevation above 1mm.

This study aims to tackle this issue with randomization of the patients into three possible treatments - intracoronary adenosine, IIb/IIIa inhibitors or nitroglycerine alone - intracoronary ST segment will be searched for reverse or residual ischemia after the pharmacologic bolus.

The intracoronary electrocardiography (i.c. ECG) is a very sensitive method for ischemia detection. The i.c. ECG reacts earlier on ischemia; the changes are much more prominent and easy to register. The wire tip could be positioned directly in different regions and thus to "map" regional ischemia. In most of the studies and from our own observations became evident that when surface ECG do not react the i.c. ECG demonstrates significant changes in ST-segment and QRS complex. Moreover, the registration of i.c. ECG is very cheap and needs only an adapter connecting coronary wire end and ECG. An i.c. ECG also can differentiate residual ischemic changes in distal main vessel and side branch as sources of prolonged ischemia, respectively - source of periprocedural myonecrosis.

Once good angiographic result is obtained after stenting there could be different reasons for ischemia in the treated region - microembolic debris or coronary microvascular spasm.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subject at least 18 years of age.
  • Target lesion(s) located in a native coronary artery with diameter of ≥ 2.5 mm and ≤ 4.5 mm. If there is side branch lesion(s) located in a native coronary artery with diameter of ≥ 2.0 mm.
  • Target lesion(s) amenable for PCI with balloon angioplasty of the side branch.

排除标准

  • Subjects with significant ST-T change (≥ 1mm).
  • Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
  • Subjects who refuse to give informed consent.
  • Subjects with the following angiographic characteristics: left main coronary artery stenosis, total occlusion target lesion, lesion of interest located at infarct-related artery.
  • Subjects with LVEF < 30%.
  • Subjects with moderate or severe degree valvular heart disease or primary cardiomyopathy.
  • LBBB, RBBB, atrial fibrillation/flutter with no identifiable isoelectric line.

研究组 & 干预措施

adenosine

Intracoronary bolus of adenosine (adenocor)

干预措施: Intracoronary bolus of adenosine (adenocor), Integrilin (eptifibatide) or nitroglyzerin (nitronal) (Drug)

GP IIb/IIIa

Intracoronary bolus of Integrilin (eptifibatide)

干预措施: Intracoronary bolus of adenosine (adenocor), Integrilin (eptifibatide) or nitroglyzerin (nitronal) (Drug)

Nitroglycerine

Intracoronary bolus of nitroglycerine (nitronal)

干预措施: Intracoronary bolus of adenosine (adenocor), Integrilin (eptifibatide) or nitroglyzerin (nitronal) (Drug)

结局指标

主要结局

Intracoronary ischemia change after intracoronary drug bolus

时间窗: 12 months

Look for ischemia change after intracoronary drugs

次要结局

  • Target lesion revascularization(12 months)
  • Number of patients not alive(12 months)
  • Myocardial infarction(12 months)
  • New onset angina or heart failure symptoms(12 months)

研究者

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

Lyubomir Dosev

Doctor, Principal Investigator

Alexandrovska University Hospital

研究点 (1)

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