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临床试验/NCT04419298
NCT04419298已完成不适用

Evaluation for Acute and Chronic Features of Cardiac Injury by CMR in Acute CO Poisoned Patients With Elevated Troponin I (TnI)

Wonju Severance Christian Hospital1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2017年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
104
试验地点
1
主要终点
Late gadolinium enhancement (LGE) in CMR

研究概览

简要总结

Previous report showed that 37% of patients with moderate to severe carbon monoxide (CO) poisoning experienced a myocardial injury, defined as elevated cardiac enzyme [creatine kinase, CK-MB, and cardiac troponin I (TnI)] or ischemic electrocardiogram (ECG) change. In other study, 24% of the patients with the myocardial injury after CO poisoning died during a median follow-up of 7.6 years. The myocardial injury was the major predictor of mortality. In addition, in the Taiwanese nationwide population-based cohort study, CO poisoning itself reported as a higher risk of a major adverse cardiovascular event.

According to the previous study of investigators, among CO poisoned patients with myocardial injury, 74.4% of patients experienced CO-induced cardiomyopathy. All CO-induced cardiomyopathy recovered to normal status. In this situation, there is no definite approved reason why more cardiovascular events are occurred in CO poisoned patients with myocardial injury during long term follow-up period despite normalization of CO-induced elevated TnI and cardiac dysfunction.

Two image cases related to cardiac magnetic resonance imaging (CMR) in acute CO poisoning previously reported. One image case reported that patient had mildly depressed left ventricular (LV) systolic function with hypokinesis of the anterior wall and regional akinesis of the inferior wall on the transthoracic echocardiography performed during hospitalization and late gadolinium-enhancement (LGE) images of CMR demonstrated multiple focal areas of high signal consistent with myocardial necrosis or fibrosis. Another image case reported an image case that in CMR, inferolateral mid-wall myocardial fibrosis, which was defined as LGE, was present despite the setting of a completely normal echocardiogram at 4-month follow-up in CO poisoned patients.

Therefore, the investigators evaluate prevalence (frequency of LGE positive) and patterns (involved LV wall and range of LGE positive) of myocardial fibrosis (LGE positive) in acute CO-poisoned patients during acute (within seven days after CO exposure) and chronic phase (at 4-5 months after CO exposure) and whether LGE positive developed in acute phase have been changed through cardiac MRI performed at chronic phase. The investigators also evaluate LV ejection fraction and global longitudinal strain in transthoracic echocardiography performed at the ED (baseline) and within seven days (follow-up). The investigators also assessed the association between neurocognitive outcomes using the global deterioration scale (at 1, 6, and 12 months after CO exposure) and the presence of LGE positive.

详细描述

In the US, carbon monoxide (CO) poisoning accounts for 1,300 deaths and 50,000 emergency department visits annually. Previous report showed that 37% of patients with moderate to severe CO poisoning experience a myocardial injury defined as elevated cardiac enzyme [creatine kinase, CK-MB, and cardiac troponin I (TnI)] or ischemic electrocardiogram (ECG) change. In other study, there was a mortality of 24% of patients during a median follow-up of 7.6 years. A mortality among the patients who experienced the myocardial injury was higher than patients without the myocardial injury. The death caused by cardiovascular problems occurred more among patients with a history of the myocardial injury (44% vs. 18%). The myocardial injury was the major predictor of mortality. In addition, in the Taiwanese nationwide population-based cohort study, a history of CO poisoning showed a higher risk of a major adverse cardiovascular event.

The investigators reported that myocardial injury (defined as elevated TnI or change of ischemic ECG) developed in 20% of CO poisoned patients and elevated TnI was normalized within 65.0 hours. According to previous study of the investigators, among CO poisoned patients with myocardial injury, 74.4% of patients experienced CO-induced cardiomyopathy. All CO-induced cardiomyopathy recovered to normal status. In this situation, there is no definite approved reason why more cardiovascular events are occurred in CO poisoned patients with myocardial injury during long term follow-up period despite normalization of CO-induced elevated TnI and cardiac dysfunction.

One case reported an image related to a CO poisoned patient with acute myocardial injury found by cardiac magnetic resonance imaging (CMR) with a normal coronary artery confirmed by coronary angiography. In that case, a patient showed that patient had mildly depressed left ventricular (LV) systolic function with hypokinesis of the anterior wall and regional akinesis of the inferior wall on the transthoracic echocardiography performed during hospitalization and late gadolinium-enhancement (LGE) images of CMR demonstrated multiple focal areas of high signal consistent with myocardial necrosis or fibrosis. Through this case, the investigators thought that CO poisoning might result in acute myocardial necrosis, demonstrating another type of myocardial injury that can be detected by CMR. In addition, Other case reported an image case that in cardiac MRI, inferolateral mid-wall myocardial fibrosis, which was defined as LGE, was present despite the setting of a completely normal echocardiogram at 4-month follow-up in a patient who experienced severe CO poisoning.

Mid-wall myocardial fibrosis has been reported in dilated cardiomyopathy (DCMP) of unclear origin. In a follow-up study of 101 consecutive patients with DCMP, mid-wall fibrosis (presented in 35% of patients) predicted a combined endpoint of all-cause mortality, cardiovascular hospitalization, and sudden cardiac death. Myocardial fibrosis has also been demonstrated in hypertrophic cardiomyopathy. The myocardial fibrosis has been linked to known markers for sudden cardiac death, although the independent prognostic value of CMR has yet to be determined.

Through above results, the investigators thought that the normal LV cardiac function may not reflect that there is no problem with the heart, and it could lead to myocardial fibrosis in the chronic phase. Myocardial damage seen through CMR may be related to the patient's prognosis. Therefore, the investigators evaluate prevalence (frequency of LGE positive) and patterns (involved LV wall and range of LGE positive) of myocardial fibrosis (LGE positive) in acute CO-poisoned patients during acute (within 7 days after CO exposure) and chronic phase (at 4-5 months after CO exposure) and whether LGE positive developed in the acute phase has been changed in cardiac MRI performed at chronic phase. The investigators also evaluate LV ejection fraction and global longitudinal strain in transthoracic echocardiography performed at the ED (baseline) and within seven days (follow-up). The investigators also assessed the association between neurocognitive outcomes using the global deterioration scale (at 1, 6, and 12 months after CO exposure) and the presence of LGE positive.

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
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Acute CO poisoning with myocardial injury, which was defined as elevated TnI (reference range < 0.045 ng/mL), within 24 hours after ED arrival.

排除标准

  • Age <19 years
  • No elevated TnI within 24 hours after ED arrival
  • Cardiac arrest upon ED arrival or before taking a CMR
  • Co-ingestion of cardiac toxic drugs
  • Transferred patients without admission
  • Declined to enrollment in the study
  • Impossible CMR due to artificial device
  • Calculated creatinine clearance (Ccr) < 30 mL/min
  • Previous known history of hypersensitivity of gadolinium
  • History of acute coronary syndrome, heart failure, or cardiomyopathy
  • Patients who refuse CMR or fail to take a CMR although written informed consent was obtained
  • Impossible of interpretation of CMR although CMR was taken

结局指标

主要结局

Late gadolinium enhancement (LGE) in CMR

时间窗: Within 7 days after acute CO poisoning

Prevalence (percent) of presence of LGE in CMR

LGE involved wall in CMR

时间窗: Within 7 days after acute CO poisoning

Injured left ventricular wall according to LGE in CMR

次要结局

  • LV GLS of TTE performed during admission(Within 7 days after CO exposure)
  • LV ejection fraction (EF) of TTE performed at the ED(Within 3 hours at the ED)
  • LGE size in CMR(Within 7 days after acute CO poisoning)
  • Change of LGE between first CMR and follow-up CMR(Within 7 days after CO exposure and at 4-5 months after CO exposure)
  • LV EF of TTE performed during admission(Within 7 days after CO exposure)
  • LV global longitudinal strain (GLS) of TTE performed at the ED(Within 3 hours at the ED)
  • Change of LV EF between ED TTE and follow-up TTE(Within 3 hours at the ED and within 7 days after CO exposure)
  • Change of LV GLS between ED TTE and follow-up TTE(Within 3 hours at the ED and within 7 days after CO exposure)
  • Correlation between presence of LGE and poor neurocognitive outcome at 1, 6, and 12 months(GDS (minimum 1 - maximum 7) evaluated at 1, 6, and 12 months after CO exposure)

研究者

发起方
Wonju Severance Christian Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yong Sung Cha

Assistant Professor

Wonju Severance Christian Hospital

研究点 (1)

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