Myocardial InfarctionMCBDTMIDTNCT04817748
Metabolomics Characterization of Biomarkers of Different Types of Myocardial Infarction in Different Time.
An observational study of Myocardial Infarction, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
To find new biomarkers through Metabonomics Study of different types of myocardial infarction in Different Time. Read more about this study
- Who is it for?
- Ages 20 to 76 yearsHealthy volunteers can take part
- Conditions the study is for
- Myocardial Infarction
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 17 Nov 2020to 1 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 76 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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：
- Ischemic symptoms
- New ischemic ECG changes, new ST-T changes or left bundle branch block（LBBB）.
- Pathological Q wave formation in ECG
- Imaging evidence showed new loss of myocardial activity or new regional wall motion abnormalities.
- 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.)
Who cannot join
- Refusal to sign informed consent.
- Surgical treatment was performed in the last three months.
- 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.
- Severe heart failure, grade IV cardiac function.
- Liver and kidney dysfunction.
- blood-borne diseases, including HIV / AIDS, hepatitis B, hepatitis C, etc.
- Patients with a history of malignancies, autoimmune diseases, severe infectious diseases and trauma.
- Previous history of myocardial infarction and stroke.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yi Zhang
Shanghai, Shanghai Municipality
Yi Zhang, 18917686332, yizshcn@gmail.com
Zheng Liu, 18521526364, 18521526364@163.com
About this study
To find new biomarkers through Metabonomics Study of different types of myocardial infarction in Different Time.
Read the 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.
- Conditions
- Myocardial Infarction
- Keywords
- myocardial infarction, metabolomics, biomarkers
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
metabolites molecules
Detection of small molecular metabolites in blood by liquid chromatography mass spectrometry and gas chromatography mass spectrometry
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start17 Nov 2020
- Primary completion1 May 2021 (estimated)
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Wei Xu, Shanghai 10th People's Hospital
- Investigators
- Yi Zhang, MD, Principal investigator, Department of Cardiology, Shanghai Tenth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04817748
- Sponsor's protocol ID
- MCBDTMIDT
- Acronym
- MCBDTMIDT
- Status last verified
- Mar 2021
- First submitted
- 13 Mar 2021
- Last updated
- 26 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolomics Characterization of Biomarkers of Different Types of Myocardial Infarction in Different Time.
- ClinicalTrials.gov ID
- NCT04817748
- Acronym / sponsor ID
- MCBDTMIDT / MCBDTMIDT
- Conditions
- Myocardial Infarction
- Keywords
- myocardial infarction, metabolomics, biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 17 Nov 2020 (actual)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To find new biomarkers through Metabonomics Study of different types of myocardial infarction in Different Time.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 76 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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：
- Ischemic symptoms
- New ischemic ECG changes, new ST-T changes or left bundle branch block（LBBB）.
- Pathological Q wave formation in ECG
- Imaging evidence showed new loss of myocardial activity or new regional wall motion abnormalities.
Key exclusion criteria (8 listed)
- Refusal to sign informed consent.
- Surgical treatment was performed in the last three months.
- 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.
- Severe heart failure, grade IV cardiac function.
- Liver and kidney dysfunction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
metabolites molecules
Time frame: 6 months
Detection of small molecular metabolites in blood by liquid chromatography mass spectrometry and gas chromatography mass spectrometry
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Zhang, MD principal investigator
Department of Cardiology, Shanghai Tenth People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction, run by Shanghai 10th People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Zhang, MD (18917686332, yizshcn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
metabolites molecules (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2021.