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临床试验/NCT04043091
NCT04043091撤回不适用

Coronary Angiography in Critically Ill Patients With Type II Myocardial Infarction

University Medical Centre Ljubljana2 个研究点 分布在 1 个国家开始时间: 2019年9月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
extent of myocardial necrosis

研究概览

简要总结

Study type: prospective cohort and randomized trial.

Duration: estimated 2 years.

Indications: Type II myocardial infarction in critically ill patients.

Purpose:

  1. To recognise the incidence of type I myocardial infarction (MI) in patients with suspected type II MI.
  2. Determining the safety of early coronary angiography in this population.
  3. Assessment of the effect of percutaneous coronary revascularization in critically ill patients with stable obstructive coronary disease and type II MI.

Hypotheses:

  1. Obstructive coronary artery disease suitable for percutaneous revascularization is present in majority of patients with type II MI.
  2. Type I MI (acute coronary artery thrombosis) is present in some patients and not recognised.
  3. Echocardiogram and a 12-lead electrocardiogram are not reliable in predicting coronary artery disease.
  4. Urgent invasive diagnostic is safe in patients with type II MI.
  5. Percutaneous revascularization (if indicated) reduces the size of myocardial necrosis in patients with type II MI.

Objectives:

  • Primary endpoint: to demonstrate that percutaneous coronary intervention (PCI) in the group with obstructive coronary disease reduces the size of MI.
  • Secondary endpoints: improved cardiac function after revascularization, shorter hospitalization, reduced mortality.
  • Safety objective: renal function, bleeding complications.

Population: 140 patients with type II MI over 18 years of age with no evidence of active bleeding.

Inclusion criteria:

  • age> 18 years
  • High sensitive troponin I > 40 ng / L for women and > 58ng / L for men
  • Critical illness (at least one vital organ support)
  • Imaging signs (electrocardiogram or ultrasound) signs of myocardial ischemia

Exclusion criteria:

  • active bleeding
  • terminal illness

Monitoring of patients: during hospitalization, 30 days after discharge, 6 months after discharge.

Performance check:

  • PCI success (% of "thrombolysis in myocardial infarction" flow 3)
  • the size of MI (troponin area under the curve)
  • left ventricular ejection fraction
  • hospital stay
  • 30 day survival

Safety Check:

  • monitoring of renal function
  • monitoring of bleeding complications
  • monitoring of allergic reactions to contrast and medication

Patient Consent: written informed consent for inclusion in the study in conscious population. In unconscious patients, written consent will be obtained in the event of mental function improvement.

详细描述

INTRODUCTION Myocardial ischemia is common in critically ill patients. When the cause of myocardial ischemia and subsequent necrosis is a mismatch between the delivery and consumption of oxygen in the myocardium and not acute coronary artery thrombosis, we are talking about type II myocardial infarction (type II MI) (1). The most common cause of such MI is infection - sepsis. The infection increases oxygen consumption in the heart muscle, which can lead to acute ischemia when the coronary reserve is reduced (chronic stable coronary disease). This is manifested by troponin leakage, ischemic changes in the electrocardiogram (ECG), or impaired contraction of the heart muscle. In critically ill patients, acute coronary artery thrombosis may also occur due to hyper coagulability, which cannot be identified without urgent invasive coronary diagnostics.

Due to the lack of data on the efficacy of acute percutaneous revascularization, these patients are generally treated medically. The cause of the increase in oxygen consumption is treated. Usually invasive diagnostics is performed only in case of severe hemodynamic instability, very high levels of troponin, or clear newly formed segmental wall contraction disorders visible on ultrasound. Delays to invasive diagnostics are generally longer than the time frames recommended for invasive diagnostics in the treatment of type I MI without the ST segment elevation in ECG (NSTE-ACS).

HYPOTHESES

  1. Obstructive coronary artery disease suitable for percutaneous revascularization is present in most patients with type II MI.
  2. Type I MI (acute coronary artery thrombosis) is misdiagnosed in some patients.
  3. Echocardiogram and a 12-lead electrocardiogram are not reliable in predicting coronary artery disease.
  4. Urgent coronary angiography is safe in patients with type II MI.
  5. Percutaneous coronary revascularization (if indicated) reduces the size of myocardial necrosis and may improve survival in the critically ill patients with type II MI.

METHODS A prospective randomized trial in critically ill patients with type II MI will be performed. All patients will undergo coronary angiography in the first 24 hours after the diagnosis. If acute coronary artery thrombosis is found, PCI will be done according to the latest European Society of Cardiology guidelines for NSTE-ACS (2). In the case of non-obstructive coronary artery disease or a normal coronary angiogram, standard treatment of the underlying disease (pneumonia, sepsis, chronic obstructive pulmonary disease, etc.) will be continued. Patients with stable obstructive coronary artery disease will be randomized into two groups - interventional and control group. The first group of patients will undergo immediate percutaneous coronary intervention (PCI) (of all obstructive lesions or until 300 mL of contrast is reached), the second group will receive only medical treatment and a delayed PCI if needed before hospital discharge.

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
None

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

  • age > 18 years
  • High sensitive troponin I > 40 ng / L for women and > 58ng / L for men
  • Critical illness (at least one vital organ support)
  • Imaging signs (ECG or ultrasound) signs of myocardial ischemia

排除标准

  • active bleeding
  • terminal illness

结局指标

主要结局

extent of myocardial necrosis

时间窗: 3 days

troponin I hs area under the curve

次要结局

  • ICU stay(30 days)
  • Left ventricular systolic function(5 days)
  • survival(30 days)

研究者

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

Peter Radsel

Asist.prof. Peter Radsel, MD, PhD

University Medical Centre Ljubljana

研究点 (2)

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