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临床试验/NCT05471739
NCT05471739已完成不适用

Simultaneous Assessment of Coronary Microvascular Dysfunction and Ischemia With Non-obstructed Coronary Arteries With Intracoronary Electrocardiogram and Intracoronary Doppler

Istanbul University1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2022年7月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
1
主要终点
Coronary Flow Reserve (CFR)

研究概览

简要总结

Coronary Microvascular Dysfunction has been consistently shown to play a considerable role in pathophysiology of Ischaemia with non-obstructed coronary arteries (INOCA). While the both diagnoses are individually related to remarkably worse outcome, there is no available method to simultaneously determine INOCA-CMD endotypes in vessel level, during the invasive diagnosis.

The investigators hereby hypothesize that, combined intracoronary electrocardiogram (IC-ECG) (considering the high sensitivity and specificity of IC-ECG for studied vessel-territory) and intracoronary doppler can simultaneously and successfully identify vessel specific coronary microvascular dysfunction and resulting ischemia, which may potentially enable immediate diagnosis and endotyping of CMD-INOCA subgroups during the invasive assessment of first ANOCA episode, obviating the need for further ischemia-studies such es SPECT, which have considerably higher costs and lower sensitivity.

Major coronary arteries of patients aged between 18 - 75 without obstructing coronary artery disease who have previously documented ischemia with non-obstructed coronary arteries (INOCA) via coronary angiogram and myocardial perfusion scan will be evaluated simultaneously with IC-ECG and intracoronary Doppler during rest and under adenosine induced hyperaemia.

Performance of the combined system to identify Coronary Microvascular Dysfunction with structural and functional subgroups as defined by abnormal Coronary Flow Reserve (CFR) and Hyperemic Microvascular Resistance (HMR) and Ischemia in downstream territories of same vessel area (as defined by perfusion scan) is intended to be determined.

The investigators also intend to interrogate the possible relationship between dynamic changes in IC-ECG parameters and invasively obtained intracoronary hemodynamic data.

详细描述

Background and Rationale of Study

Coronary Microvascular Dysfunction has been consistently shown to play a considerable role in pathophysiology of Ischaemia with non-obstructed coronary arteries (INOCA). While the both diagnoses are individually related to remarkably worse outcome, there is no available method to simultaneously determine INOCA-CMD endotypes in vessel level, during the invasive diagnosis.

Hypothesis

The investigators hereby hypothesize that, combined intracoronary electrocardiogram (IC-ECG) (considering its high sensitivity for ischemia and specificity for studied vessel-territory) and intracoronary doppler can simultaneously and successfully identify vessel specific coronary microvascular dysfunction and resulting ischemia, which may potentially enable immediate diagnosis and endotyping of CMD-INOCA subgroups during the invasive assessment of first ANOCA episode, obviating the need for further ischemia-studies such as SPECT, which have considerably higher costs and lower sensitivity and requires more hospital visits.

Study Method

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥1 previous episode of typical angina pectoris with normal coronary angiograms (Angina with Non-obstructed Coronary Arteries)
  • positive myocardial perfusion scan (MPS) for ischemia or slow-flow.

排除标准

  • obstructive epicardial coronary artery disease of at least 1 coronary artery in angiogram
  • lung disease causing severe bronchospasm
  • NYHA III - IV Heart Failure
  • Bundle Branch Block
  • Hb < 10 g/dL
  • Active Malignancy
  • Active Infection
  • Morbid Obesity
  • Pacemaker (Actively Pacing)
  • Peripheral Artery Disease
  • Previous CABG
  • Chronic Hypoxia due to lung diseases

结局指标

主要结局

Coronary Flow Reserve (CFR)

时间窗: Intraprocedural during coronary angiography

the ratio between coronary blood flow at maximal hyperemia and at baseline condition

Hyperemic Microvascular Resistance (HMR)

时间窗: Intraprocedural during coronary angiography

the ratio of mean distal coronary pressure to average flow velocity

Delta ST

时间窗: Intraprocedural during coronary angiography

absolute shift of ST segment in IC-ECG record (at J point)

Delta ST Integral

时间窗: Intraprocedural during coronary angiography

absolute change in area between ST segment and isoelectric line

次要结局

  • Hyperemic Average Peak Velocity(Intraprocedural during coronary angiography)
  • Resting Average Peak Velocity(Intraprocedural during coronary angiography)

研究者

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

Dr. Murat Sezer

MD, Professor

Istanbul University

研究点 (1)

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