Ignite Creation Date:
2024-05-06 @ 2:44 PM
Last Modification Date:
2024-10-26 @ 1:37 PM
Study NCT ID:
NCT04419298
Status:
COMPLETED
Last Update Posted:
2020-06-05
First Post:
2020-05-28
Brief Title:
Cardiac Magnetic Resonance Image CMR in Acute Carbon Monoxide CO Poisoning
Sponsor:
Wonju Severance Christian Hospital
Organization:
Wonju Severance Christian Hospital
Study Overview
Official Title:
Evaluation for Acute and Chronic Features of Cardiac Injury by CMR in Acute CO Poisoned Patients With Elevated Troponin I TnI
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 76 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 744 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
According to the previous study of investigators among CO poisoned patients with myocardial injury 744 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
Detailed Description:
In the US carbon monoxide CO poisoning accounts for 1300 deaths and 50000 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 76 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 650 hours According to previous study of the investigators among CO poisoned patients with myocardial injury 744 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 patients 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
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 650 hours According to previous study of the investigators among CO poisoned patients with myocardial injury 744 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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None