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

March 23, 2021 updated by: Ya-Wei Xu, Shanghai 10th People's Hospital
To find new biomarkers through Metabonomics Study of different types of myocardial infarction in Different Time.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  1. Different types of myocardial infarction were identified according to the international definition of myocardial infarction and 2020 guidelines and consensus on myocardial infarction.
  2. Patients with normal coronary arteries were determined according to the results of coronary angiography.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
metabolites molecules
Time Frame: 6 months
Detection of small molecular metabolites in blood by liquid chromatography mass spectrometry and gas chromatography mass spectrometry
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai 10th People's Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2020

Primary Completion (Anticipated)

May 1, 2021

Study Completion (Anticipated)

May 1, 2021

Study Registration Dates

First Submitted

March 13, 2021

First Submitted That Met QC Criteria

March 23, 2021

First Posted (Actual)

March 26, 2021

Study Record Updates

Last Update Posted (Actual)

March 26, 2021

Last Update Submitted That Met QC Criteria

March 23, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCBDTMIDT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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