Ignite Creation Date:
2024-05-06 @ 12:21 PM
Last Modification Date:
2024-10-26 @ 12:57 PM
Study NCT ID:
NCT03734796
Status:
UNKNOWN
Last Update Posted:
2018-11-08
First Post:
2018-11-05
Brief Title:
Hs-cTnI Diagnosis of NSTE-ACS Patients in China
Sponsor:
China National Center for Cardiovascular Diseases
Organization:
China National Center for Cardiovascular Diseases
Study Overview
Official Title:
The Study of High-sEnsitivity cArDiac Troponin I vaLues and Changes In diagNosis of suspEcted Acute Coronary Syndrome Patients in China
Status:
UNKNOWN
Status Verified Date:
2018-11
Last Known Status:
RECRUITING
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:
HEADLINES
Brief Summary:
This study is to validate 1-hour and 3-hours diagnostic strategy using Architect high-sensitivity cardiac troponin I hs-cTnI in Chinese patients with suspected Non-ST-elevation Myocardial Infarction NSTEMI The accuracy of 1-hour and 3-hours algorithm of NSTEMI using hs-cTnI assays will be evaluated in China emergency patients This trail is going to determine the optimal diagnostic cut-off value of NSTEMI in Chinese population according to 24-hour or longer clinical diagnosis of MI in routine way
Detailed Description:
Cardiac Troponin is recommended as a preferred cardiac biomarker in third universal definition of myocardial infraction The validated high-sensitive cardiac troponin I is also considered competent 1-hour algorithm to rule out and rule in NSTEMI in 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation However the diagnostic threshold of 1-hour and 3-hour need more solid evidence in Chinese population This study is to validate 1-hour and 3-hours diagnostic strategy using Architect high-sensitivity cardiac troponin I hs-cTnI in Chinese patients with suspected non-ST-elevation Myocardial Infarction NSTEMI The accuracy of 1-hour and 3-hours algorithm of NSTEMI using Architect hs-cTnI assays will be assessment in China emergency patients This trail is going to determine the optimal diagnostic cut-off value of NSTEMI in Chinese population according to 24-hour or even longer clinical diagnosis of MI in routine way
In primary phase of the present study 400 patients with acute chest pain who suspected NSTE-ACS will be enrolled when visiting emergency department of Fuwai hospital In subsequent study multi center emergency department in China plan to recruit 2000 patients suspected NSTE-ACS The inclusion and exclusion criteria had been described in the following eligibility part All recruited patients undergo an initial clinical assessment including clinical history physical examination 12-lead ECG monitoring routine blood measurements and echocardiogram The blood samples of patients will be collected according to standard biobank protocol Cardiac troponin I CK-MB and myoglobin will be measured at presentation 1-hour 3-hours and 12-hours employing contemporary cTnI and high-sensitive cTnI respectively
The diagnosis of each enrolled patient will be made according to routine clinical approach and 1-hour and 3-hours clinical approach respectively The routine clinical diagnosis will be made by cardiologist panel according to third universal definition of myocardial infraction through reviewing all available medical records The NSTEMI diagnosis depended on Architect hs-cTnI assessment will be made a senior cardiologist according to 1-hour and 3-hours clinical approach recommended by 2015 ESC guidelines for the management of NSTEMI When there was disagreement about the diagnosis cases were reviewed and adjudicated in conjunction with a third senior cardiologist
Finally statistical expert will evaluate the diagnostic performance of 1-hour and 3-hours clinical approach and diagnostic threshold of NSTEMI when the new hs-cTnI employed
In primary phase of the present study 400 patients with acute chest pain who suspected NSTE-ACS will be enrolled when visiting emergency department of Fuwai hospital In subsequent study multi center emergency department in China plan to recruit 2000 patients suspected NSTE-ACS The inclusion and exclusion criteria had been described in the following eligibility part All recruited patients undergo an initial clinical assessment including clinical history physical examination 12-lead ECG monitoring routine blood measurements and echocardiogram The blood samples of patients will be collected according to standard biobank protocol Cardiac troponin I CK-MB and myoglobin will be measured at presentation 1-hour 3-hours and 12-hours employing contemporary cTnI and high-sensitive cTnI respectively
The diagnosis of each enrolled patient will be made according to routine clinical approach and 1-hour and 3-hours clinical approach respectively The routine clinical diagnosis will be made by cardiologist panel according to third universal definition of myocardial infraction through reviewing all available medical records The NSTEMI diagnosis depended on Architect hs-cTnI assessment will be made a senior cardiologist according to 1-hour and 3-hours clinical approach recommended by 2015 ESC guidelines for the management of NSTEMI When there was disagreement about the diagnosis cases were reviewed and adjudicated in conjunction with a third senior cardiologist
Finally statistical expert will evaluate the diagnostic performance of 1-hour and 3-hours clinical approach and diagnostic threshold of NSTEMI when the new hs-cTnI employed
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?:
True
Is an FDA AA801 Violation?:
None