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Trial record 47 of 176 for:    Recruiting, Not yet recruiting, Available Studies | Chest pain

Hs-cTnI Diagnosis of NSTE-ACS Patients in China (HEADLINES)

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ClinicalTrials.gov Identifier: NCT03734796
Recruitment Status : Recruiting
First Posted : November 8, 2018
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
China National Center for Cardiovascular Diseases

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.

Condition or disease
Non-ST-elevation Myocardial Infarction (NSTEMI)

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.


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Study Type : Observational
Estimated Enrollment : 2400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Study of High-sEnsitivity cArDiac Troponin I vaLues and Changes In diagNosis of suspEcted Acute Coronary Syndrome Patients in China
Actual Study Start Date : January 9, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Group/Cohort
suspected NSTEMI
Patients aged 18-75 years old and highly suspected NSTEMI without Left bundle branch block (LBBB) will be included. Patients will be excluded if who is STEMI, underwent surgical operation within four weeks, medium and several kidney dysfunction (Ccr<30ml/min), anemia, acute myocarditis, chronic cardiac dysfunction (NYHA III-IV), serious cardiac arrhythmias, with history of intravenous drug, oncosis and recent thrombolysis treatment, or pregnant.



Primary Outcome Measures :
  1. Acute Myocardial Infarction [ Time Frame: 0 - 72 hour ]
    Number of Participants with NSTEMI



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
In primary phase of the present study, 400 patients with acute chest pain, who suspected NSTEMI, 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 NSTEMI. Patients aged 18-75 years old and highly suspected NSTEMI without Left bundle branch block (LBBB) will be included. Patients will be excluded if who is STEMI, underwent surgical operation within four weeks, medium and several kidney dysfunction (Ccr<30ml/min), anemia, acute myocarditis, chronic cardiac dysfunction (NYHA III-IV), serious cardiac arrhythmias, with history of intravenous drug, oncosis and recent thrombolysis treatment, or pregnant.
Criteria

Inclusion Criteria:

  • 18-75y;
  • highly suspected NSTEMI;
  • ECG results without ST-segment elevation;
  • without new Left bundle branch block (LBBB) ;

Exclusion Criteria:

  • STEMI;
  • underwent major surgical operation or injury within four weeks;
  • medium and several kidney dysfunction (Ccr<30ml/min);
  • anemia(Hb<90g/L);
  • acute myocarditis;
  • chronic cardiac dysfunction (NYHA III-IV);
  • serious cardiac arrhythmias;
  • Have had similar symptoms and treatment with thrombolysis before one month;
  • history of intravenous drug;
  • history of oncosis;
  • pregnant;
  • even recruited;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03734796


Contacts
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Contact: Yan Liang, MD +861088322803 fwliangyan2016@163.com
Contact: Zhou Zhou, MD, PhD +861088398055 fwcomd@126.com

Locations
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China, Beijing
Yan Liang Recruiting
Beijing, Beijing, China, 100037
Contact: Yahui Lin, Ph.D.    +8610-88398271    linyahui@263.net   
Sponsors and Collaborators
China National Center for Cardiovascular Diseases
Investigators
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Study Chair: Yan Liang, MD Department of Emergency Medicine, State Key Laboratory of Cardiovascular Disease National Center for Cardiovascular Diseases & Fuwai Hospital Peking Union Medical College & Chinese Academy of Medical Sciences
Study Chair: Zhou Zhou, MD, PhD Center of Laboratory Medicine Beijing Key Laboratory for Molecular Diagnostics of Cardiovascular Disease State Key Laboratory of Cardiovascular Disease National Center for Cardiovascular Diseases & Fuwai Hospital Peking Union Medical College & Chinese Aca

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Responsible Party: China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier: NCT03734796     History of Changes
Other Study ID Numbers: HEADLINES
First Posted: November 8, 2018    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by China National Center for Cardiovascular Diseases:
High-sensitive cardiac troponin
Non-ST-elevation Myocardial Infarction (NSTEMI)
Chinese
Acute chest pain
Additional relevant MeSH terms:
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Myocardial Infarction
Non-ST Elevated Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases