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临床试验/NCT05583786
NCT05583786招募中不适用

Intracoronary ECG ST-segment Shift Remission Time During Reactive Coronary Hyperemia, τ-icECG: a New Method for Assessing Hemodynamic Stenosis Severity

Insel Gruppe AG, University Hospital Bern1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
icECG ST-segment shift remission time (τ-icECG)

研究概览

简要总结

This study evaluates a new diagnostic approach based on intracoronary electrocardiogram (icECG) ST-segment shift remission time, denoted as τ-icECG (τ=tau, i.e., the remission half-time fitted by an exponential function to the disappearing ST-segment shift), to be used for PCI guidance.

详细描述

Cardiovascular disease is the major cause of death globally, accounting for 17.9 million deaths per year in 2019. Aside from the acute coronary syndrome, where percutaneous coronary intervention (PCI) has been shown to improve outcome, the number of patients with chronic coronary syndrome (CCS) is also increasing. PCI of hemodynamically relevant stenotic lesions causing myocardial ischemia is the standard treatment in these patients. Effective revascularization, as recommended by the European Society of Cardiology (ESC) guidelines, requires to differentiate between hemodynamically relevant and non-significant stenotic coronary lesions.

Currently, coronary stenosis assessment is performed by structural visual angiographic assessment or by coronary pressure measurements up- and downstream of the lesion. The latter is recommended by the ESC and is based on its prognostic value derived from large randomized clinical trials. Given temporary paralysis of the coronary microcirculation by a hyperemia-inducing substance such as adenosine (ADO), pressure is, in theory, directly related to coronary flow. Therefore, the pressure drop during hyperemia across a coronary stenosis, i.e., fractional flow reserve (FFR) provides an estimate of its restrictive effect on flow. However, this method depends on expensive pressure sensor angioplasty guidewires, and on hyperemia-inducing substances, such as ADO. Hence, pharmacologic limitations such as atrioventricular conduction defects and asthma and other potential adverse events (e.g. arrhythmias) aside from costs are major drawbacks of pressure-derived FFR. In order to avoid potential drug-induced side effects and achieve maximal hyperemia, the study group performs reactive hyperemia FFR measurements induced by a proximal, 1-minute coronary artery balloon occlusion. This method has been documented non-inferior in its ability to detect relevant coronary stenosis compared to adenosine-induced FFR.

The present project aims at validating a novel, potentially more harmless, faster and less costly diagnostic approach for measuring hemodynamic coronary stenosis severity.

The commonly obtained surface lead electrocardiogram (ECG) is limited in detecting short-lasting or minor myocardial ischemia. In comparison, intracoronary ECG (icECG) is more time- and space-sensitive in detecting myocardial ischemia, the latter being due to its close vicinity to the myocardial region of interest. It can be easily obtained by attaching an alligator clamp to a coronary guidewire.

Based on the sensitivity of the icECG, several clinical trials have assessed the value of icECG to guide PCI, and rated it useful to predict post-procedural myocardial injury.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic coronary syndrome
  • Chronic stable 1-3 vessel coronary artery disease
  • Coronary stenotic lesion of any diameter narrowing
  • Age > 18 years
  • Referred for elective coronary angiography to the investigators institution
  • Written informed consent to participate in the study

排除标准

  • Acute coronary syndrome
  • Unstable cardiopulmonary condition
  • Severe aortic valve stenosis
  • Acute congestive heart failure NYHA (New York Heart Association) III-IV
  • ECG bundle branch blocks, non-sinus rhythm or paced rhythm
  • Coronary anatomy unsuitable for coronary measurements
  • Severe pulmonary, renal or hepatic disease
  • Women of childbearing age (≤50years and ≤12months after the last menstruation)

结局指标

主要结局

icECG ST-segment shift remission time (τ-icECG)

时间窗: once after a 1-minute coronary ballon occlusion

The primary study objective is to test reactive hyperemia τ-icECG as obtained immediately after a 1-minute upstream coronary artery balloon occlusion as a new method to determine the hemodynamic significance of a coronary artery stenosis. As primary reference method, reactive hyperemia FFR (cut-off 0.80) is employed.

次要结局

  • Reactive hyperemia FFR (primary reference)(once after a 1-minute coronary ballon occlusion)
  • Quantitative percent diameter narrowing (secondary reference) (%S)(once after a 1-minute coronary ballon occlusion)
  • Instantaneous wave-free ratio (iFR)(once before a 1-minute coronary ballon occlusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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