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MCBDTMIDT: Metabolomics Characterization of Biomarkers of Different Types of Myocardial Infarction in Different Time.

Sponsor
Shanghai 10th People's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04817748
Collaborator
(none)
40
Enrollment
1
Location
5.4
Anticipated Duration (Months)
7.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To find new biomarkers through Metabonomics Study of different types of myocardial infarction in Different Time.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    In recent years, with the deepening understanding of the mechanism of myocardial infarction, in addition to the early understanding of plaque rupture, plaque erosion and other mechanisms, studies have found that inflammation, immunity, metabolism and other factors also play an increasingly important role in the occurrence and development of myocardial infarction. The LoDoCo2 study published at the 2020 ESC annual meeting and the COLCOT study previously published confirmed for the first time the therapeutic effect of anti-inflammatory drug colchicine in chronic coronary disease and acute myocardial infarction. At the same time, the fourth international definition of myocardial infarction also defines three different types of acute ST segment elevation myocardial infarction (STEMI), acute non ST segment elevation myocardial infarction (NSTEMI) and non infarct acute myocardial infarction (MINOCA). However, there are no clear research results on the mechanism, especially the mechanism of MINOCA. Therefore, the study of acute myocardial infarction in three groups is of great significance.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Metabolomics Characterization of Biomarkers of Different Types of Myocardial Infarction in Different Time.
    Actual Study Start Date :
    Nov 17, 2020
    Anticipated Primary Completion Date :
    May 1, 2021
    Anticipated Study Completion Date :
    May 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Acute ST segment elevation myocardial infarction（STEMI）

    the patients' coronary and venous blood were drawn for metabolomics study
    Acute non ST segment elevation myocardial infarction（NSTEMI）

    the patients' coronary and venous blood were drawn for metabolomics study
    Acute myocardial infarction with no obstructive coronary atherosclerosis（MINOCA）

    the patients' coronary and venous blood were drawn for metabolomics study
    Patients with normal coronary artery（NCA)

    the patients' coronary and venous blood were drawn for metabolomics study

    Outcome Measures

    Primary Outcome Measures

    1. metabolites molecules [6 months]

      Detection of small molecular metabolites in blood by liquid chromatography mass spectrometry and gas chromatography mass spectrometry

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 76 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1.The patient clearly had acute myocardial infarction. 2.The patient's serum cardiac markers (mainly troponin) were elevated (at least above the upper limit of 99% reference value) and accompanied by one of the following clinical indicators：

    1. Ischemic symptoms

    2. New ischemic ECG changes, new ST-T changes or left bundle branch block（LBBB）.

    3. Pathological Q wave formation in ECG

    4. Imaging evidence showed new loss of myocardial activity or new regional wall motion abnormalities.

    5. The thrombus was confirmed by coronary angiography. 3．The patient had chest pain symptoms, but coronary angiography showed normal coronary artery (such as intercostal neuralgia, cervical spondylosis, chest pain of unknown origin, etc.)

    Exclusion Criteria:

    1. Refusal to sign informed consent.

    2. Surgical treatment was performed in the last three months.

    3. Patients with a history of the following diseases or consider the diagnosis of the following diseases：Stress cardiomyopathy, myocarditis, pericarditis, pneumonia, pulmonary embolism, aortic dissection.

    4. Severe heart failure, grade IV cardiac function.

    5. Liver and kidney dysfunction.

    6. blood-borne diseases, including HIV / AIDS, hepatitis B, hepatitis C, etc.

    7. Patients with a history of malignancies, autoimmune diseases, severe infectious diseases and trauma.

    8. Previous history of myocardial infarction and stroke.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yi Zhang Shanghai Shanghai China

    Sponsors and Collaborators

    • Shanghai 10th People's Hospital

    Investigators

    • Principal Investigator: Yi Zhang, MD, Department of Cardiology, Shanghai Tenth People's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ya-Wei Xu, cardiology department of shanghai 10th people's hospital, Shanghai 10th People's Hospital
    ClinicalTrials.gov Identifier:
    NCT04817748
    Other Study ID Numbers:
    • MCBDTMIDT
    First Posted:
    Mar 26, 2021
    Last Update Posted:
    Mar 26, 2021
    Last Verified:
    Mar 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ya-Wei Xu, cardiology department of shanghai 10th people's hospital, Shanghai 10th People's Hospital
    myocardial infarction
    metabolomics
    biomarkers
    Additional relevant MeSH terms:
    Myocardial Infarction
    Infarction

    Study Results

    No Results Posted as of Mar 26, 2021