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临床试验/NCT02004483
NCT02004483已完成不适用

Comprehensive Analysis of Myocardial Layer Specific Systolic and Diastolic Function in Patients With Coronary Artery Disease Undergoing Percutaneous Coronary Intervention

RWTH Aachen University1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2010年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
1
主要终点
systolic and diastolic function

研究概览

简要总结

Investigators will analyzed systolic and diastolic function during and after ischemia induced by percutaneous coronary intervention.Also will be analyzed a local work index during acute ischemia induced by percutaneous coronary intervention.

详细描述

PART 1: ANALYSIS OF LAYER SPECIFIC SYSTOLIC AND DIASTOLIC FUNCTION DURING ACUTE ISCHEMIA INDUCED BY PERCUTANEOUS CORONARY INTERVENTION 35 patients with normal systolic left ventricular function at baseline with indication for elective percutaneous coronary angioplasty will be included in the study. In these patients acute ischemia will be induced by elective percutaneous coronary angioplasty with balloon inflation and thus vessel occlusion for 60 sec. During these 60 seconds ischemia will develop throughout all layers of the myocardium affecting diastolic systolic and diastolic function. During the subsequent reperfusion period signs of ischemia with systolic and diastolic dysfunction of all layers will subside. Echocardiographic imaging at short intervals of 10 sec during ischemia and at intervals of 20 sec during reperfusion up to 10 min after reopening of the vessel as well as 1 hour and 24 hours later will allow serial comparison of strain curves and thereby allow definition of the time sequence systolic and diastolic function abnormalities occur in three myocardial layers as well as the resolution of abnormalities during reperfusion. The analysis of circumferential as well as radial strain will allow definition of differences between radial and circumferential strain during ischemia induction and resolution.

PART 2: ANALYSIS OF LOCAL WORK INDEX DURING ACUTE ISCHEMIA INDUCED BY PERCUTANEOUS CORONARY INTERVENTION.

In the same 35 patients as in Clinical step 1 the local work index of the ischemic area as well as the contralateral non-ischemic areas will be determined in serial studies to determine the onset of abnormality, the amount of abnormality and the resolution of abnormality. Changes in local work index in the ischemic area will be related to changes in peak systolic strain and strain imaging diastolic index.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Signed informed consent.
  • •Adequate quality of echocardiographic images.
  • •Significant stenosis of the proximal left anterior descending artery, the right coronary artery or the left circumflex artery
  • •Anginal pain or proven myocardial ischemia due to the coronary stenosis
  • •Elective percutaneous coronary intervention planned
  • •Planned direct stenting of the coronary artery

排除标准

  • •Prior myocardial infarction
  • •Significant coronary collaterals
  • •Significant valvular regurgitation (>Sellers II)
  • •Congestive heart failure
  • •Pacemaker dependency
  • •Bundle branch block or significant arrhythmia
  • •Atrial fibrillation
  • •Previous coronary bypass grafting
  • •Impaired kidney function corresponding to a GFR(Glomerular filtration rate) below 60 mL/min.
  • •Women, who are pregnant or breastfeeding.
  • •Patient taking part in another clinical study
  • •Subjects who are committed to an institution and/or penitentiary by judicial or official order.
  • •Complex coronary lesion requiring balloon angioplasty or rotational atherectomy prior to stenting

研究组 & 干预措施

Percutaneous Coronary Intervention

Experimental

Each patient will get elective percutaneous coronary angioplasty with balloon inflation(PCI). During and after PCI 2D-echography (strain) will be performed.

干预措施: Percutaneous Coronary Intervention (Procedure)

结局指标

主要结局

systolic and diastolic function

时间窗: during 60 seconds ischemia caused by PCI

Echocardiographic imaging at short intervals of 10 sec during ischemia, which will be induced by elective percutaneous coronary angioplasty with balloon inflation and thus vessel occlusion for 60 sec.

次要结局

  • systolic and diastolic function(during 10 minutes, after 1 hour and after 24 hours after PCI)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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