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A Registry Study on Genetics and Biomarkers of Acute Coronary Syndrome (ARSGB-ACS)

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ClinicalTrials.gov Identifier: NCT03752515
Recruitment Status : Recruiting
First Posted : November 26, 2018
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Beijing Institute of Heart, Lung and Blood Vessel Diseases

Brief Summary:
This is a national registry study to determine genetics risk factors and serial biomarkers of Acute Coronary Syndrome.

Condition or disease
Coronary Artery Disease Acute Coronary Syndrome Acute Myocardial Infarction Unstable Angina

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Chinese Registry to Determine the Genetics Risk Factors and Serumal Biomarkers for Acute Coronary Syndrome
Actual Study Start Date : June 2, 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : October 2020

Group/Cohort
case
control



Primary Outcome Measures :
  1. Age for each participant [ Time Frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting ]
  2. Gender for each participant [ Time Frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting ]
  3. Height for each participant [ Time Frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting ]
  4. Weight for each participant [ Time Frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting ]
  5. Contact information for each participant [ Time Frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting ]
  6. Past Medical History including disease history, surgical history, and family medical history [ Time Frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting ]
  7. Lifestyle including smoking history and drinking, specify how many years smoking or drinking lasted and detail quantity per day [ Time Frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting ]
  8. Exon sequencing data of each participant [ Time Frame: Sequencing will be carried out in an average of 3 months after sample recruiting ]
  9. Metabolomic profile on Liquid Chromatograph Mass Spectrometer/Mass Spectrometer analysis of serum sample. [ Time Frame: The data is collected from lab in an average of 3 month after the sample recruiting ]
    The results of metabolomics will be measured by mass spectrometry, including lipids, sugars, amino acids, carnitine, choline, arachidonic acid, sterol and free fat acid . All of metabolites will be quantitative (unit: mol/L). Identification of molecules via Human Metabolites Database will be reported online.

  10. Detection of miRNAs expression in each participant using the qRT-PCT method. [ Time Frame: The data is collected from lab in an average of 3 month after the sample recruiting ]
    Relative expression levels of miRNA were analyzed using the 2-△Ct method and U6 was used as an endogenous control.

  11. Major adverse cardiovascular events (MACE) in overall population, defined as composite of all-cause death, Heart Failure hospitalization, recurrent myocardial infarction, stroke or ischemia-driven revascularization. [ Time Frame: These data is collected during follow-up visit at 3/6/12/24/36 months after discharge ]

Biospecimen Retention:   Samples With DNA

If a blood specimen is obtained, it will be separated and stored at -80 ℃ as plasma, viable cells, and extracted DNA. If a saliva specimen is obtained, it is stored for DNA.

If a tissue specimen is obtained, it will be cut into small pieces and stored at liquid nitrogen.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
case group consists of patients who was diagnosed as Acute Coronary Syndrome. control group is general population without Acute Coronary Syndrome.
Criteria

Case Inclusion Criteria:

  • Written informed consent has been provided.
  • Contact Order Form has been provided.
  • Aged 18 years or older.
  • Hospitalized within 48 hours of onset of symptoms.
  • Diagnosis of STEMI, NSTEMI or UA using the following definitions:

    1.Criteria for STEMI diagnosis:

    1. History of chest pain/discomfort and
    2. Persistent ST-segment elevation (> 30 min) of ≥ 0.1 mV in 2 or more contiguous ECG leads or presumed new left bundle branch block (LBBB) on admission and
    3. Elevation of cardiac biomarkers (CK-MB, troponins): at least one value above the 99th percentile of the local laboratory upper reference limit.

    2.Criteria for NSTEMI diagnosis:

    1.History of chest pain/discomfort and 2.Lack of persistent ST-segment elevation, LBBB or intraventricular conduction disturbances and 3.Elevation of cardiac biomarkers (CK-MB, troponins): at least one value above the 99th percentile of the local laboratory upper reference limit. 3.Criteria for Unstable Angina diagnosis:

    1. Symptoms of angina at rest or on minimal exercise and
    2. At least 0.5mm ST deviation in at least 2 leads and
    3. No increase in biomarkers of necrosis
    4. OR objective evidence of ischaemia by non-invasive imaging OR significant coronary stenosis as determined by the treating physician at angiography if this is standard practice in study site.

      Case Exclusion Criteria:

      Patients will not be eligible to participate if any of the following exclusion criteria are present:

  • UA, STEMI and NSTEMI precipitated by or as a complication of surgery, trauma, or GI bleeding or post-PCI.
  • UA, STEMI and NSTEMI occurring in patients already hospitalized for other reasons.
  • Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient (e.g. tourist, non-native speaker or does not understand the local language, psychiatric disturbances).
  • Presence of serious/severe co-morbidities in the opinion of the investigator which may limit short term (i.e. 6 month) life expectancy.
  • Current participation in a randomised interventional clinical trial.

Control Inclusion Criteria:

  • Age and gender are matched with cases.
  • No Coronary Artery Disease was detected by Coronary CT examination.
  • Normal biochemical indicators.

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): NCT03752515


Contacts
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Contact: Yulin Li, PHD lyllyl_1111@163.com

Locations
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China
Beijing Anzhen Hospital Recruiting
Beijing, China, 100029
Contact: ke-xu Yang    86-010-64426153    EC@anzhenGCP.com   
Sponsors and Collaborators
Beijing Institute of Heart, Lung and Blood Vessel Diseases
Investigators
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Study Director: Jie Du, PHD Beijing Anzhen Hospital

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Responsible Party: Beijing Institute of Heart, Lung and Blood Vessel Diseases
ClinicalTrials.gov Identifier: NCT03752515     History of Changes
Other Study ID Numbers: BeijingIHLBVD2018010
First Posted: November 26, 2018    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Syndrome
Infarction
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Acute Coronary Syndrome
Angina, Unstable
Disease
Pathologic Processes
Ischemia
Necrosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms