Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03734796 |
| Other study ID # |
HEADLINES |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 9, 2017 |
| Est. completion date |
December 31, 2019 |
Study information
| Verified date |
November 2018 |
| Source |
China National Center for Cardiovascular Diseases |
| Contact |
Yan Liang, MD |
| Phone |
+861088322803 |
| Email |
fwliangyan2016[@]163.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
