STEMINCT05601310
Metabolic Characteristics of Type 2 Diabetes Mellitus Combined With Acute Myocardial Infarction: A Untargeted Metabolomics Study
An observational study of STEMI, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
This study is a retrospective case-control study. In this study, through untargeted metabolomics, investigators identified several specific changed serum metabolites in T2DM patients with or without AMI and their functions/category. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- STEMI
- What is being tested?
- liquid chromatography-mass spectrometry (LC/MS) analysis
- Type of treatment
- Medical device
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- 23 May 2017to 28 May 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ① Patients with acute ST-segment elevation myocardial infarction (STEMI) who underwent emergency PCI in Beijing Friendship Hospital (Xicheng District) affiliated to Capital Medical University. ②In the Beijing Friendship Hospital (Xicheng District) affiliated to Capital Medical University, coronary angiography showed negative coronary angiography or coronary artery CT showed <50% obstruction in patients with non-coronary heart disease.
Who may be able to join
- STEMI patients meet the diagnostic criteria of "Guidelines for the Diagnosis and Treatment of Acute ST-segment Elevation Myocardial Infarction (2015)".
- STMEI patients undergoing emergency PCI should undergo emergency PCI within 12 hours of onset at Beijing Friendship Hospital affiliated to Capital Medical University.
- All diabetic patients meet the diagnostic criteria for type 2 diabetes.
- They agreed to be enrolled in the trial and signed the informed consent.
Who cannot join
- Combined with severe valvular disease or congenital heart disease, hypertension, chronic kidney disease, stroke, hyperlipidemia, previous history of coronary artery disease.
- Involved in acute infection, severe hepatic dysfunction, tumor, rheumatic immune disease.
- Incomplete clinical information.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 12,13-DHOME and Noradrenaline Are Associated With Occurrence of Acute Myocardial Infarction in Patients With Type 2 Diabetes Mellitus: A Untargeted Metabolomics Study
This study is a retrospective case-control study. In this study, through untargeted metabolomics, investigators identified several specific changed serum metabolites in T2DM patients with or without AMI and their functions/category. Moreover, researchers selected several endogenous candidate biomarkers with larger fold change for validation in expanded population to find biomarkers which effectively predict the development of STEMI in patients with T2DM.
- Conditions
- STEMI
- Being tested
- liquid chromatography-mass spectrometry (LC/MS) analysis
- Keywords
- STEMI, Metabolomics, Biomarkers, Type 2 Diabetes Mellitus
- Medical subject headings
- ST Elevation Myocardial Infarction, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liquid chromatography-mass spectrometry (LC/MS) analysisDevice
To obtain a complete metabolic profile, untargeted metabolomics analysis was conducted by using UPLC-MS. Chromatographic separation was accomplished in an Thermo Vanquish system equipped with an ACQUITY UPLC®HSS T3 (150×2.1 mm, 1.8 µm, Waters, USA) column maintained at 40 ℃. The temperature of the autosampler was 8 ℃. The ESI-MSn experiments were executed on the Thermo Q Exactive mass spectrometer with the spray voltage of 3.5 kV and -2.5 kV in positive and negative modes, respectively. The capillary temperature was 325℃. The analyzer scanned over a mass range of m/z 81-1 000 for full scan at a mass resolution of 70 000. The normalized collision energy was 30 eV(19606840). The detected ions were all under isotopic calibration with the accurate masses of the reference standards.
| Study group | Role | What they receive |
|---|---|---|
| Control group | in the group, the participants exhibited negative results or <50% obstruction upon coronary artery CT or coronary angiography. The group did not have coronary heart disease and diabetes Receives: Device: liquid chromatography-mass spectrometry (LC/MS) analysis | |
| T2DM group | in the group, the participants exhibited negative results or <50% obstruction upon coronary artery CT or coronary angiography. The group did not have coronary heart disease but have type 2 diabetes mellitus. Receives: Device: liquid chromatography-mass spectrometry (LC/MS) analysis | |
| T2DM+AMI group | In the group, we eventually recruited 30 adult patients who were firstly diagnosed ST-elevation myocardial infarction (STEMI) within 12 hours of appearance chest pains or other AMI symptoms and had no previous history of coronary artery disease (CAD). Peripheral venous blood samples were drawn from subjects on admission or prior to coronary revascularization. Receives: Device: liquid chromatography-mass spectrometry (LC/MS) analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
There are differences in the metabolic profile of diabetic patients with or without combined acute myocardial infarction
About 10ml of venous blood was collected on the admission, serum was separated. To obtain a complete metabolic profile, untargeted metabolomics analysis was conducted by using UPLC-MS.
Measured: December 16th, 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start23 May 2017
- Primary completion28 May 2020
- Study completion28 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STEMIStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weiping Li, Beijing Friendship Hospital
- Investigators
- Weiping Li, MD, Study director, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601310
- Sponsor's protocol ID
- BFH-Metabolomics and STEMI
- Status last verified
- Oct 2022
- First submitted
- 18 Oct 2022
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 12,13-DHOME and Noradrenaline Are Associated With Occurrence of Acute Myocardial Infarction in Patients With Type 2 Diabetes Mellitus: A Untargeted Metabolomics Study
- ClinicalTrials.gov ID
- NCT05601310
- Acronym / sponsor ID
- BFH-Metabolomics and STEMI
- Conditions
- STEMI
- Keywords
- STEMI, Metabolomics, Biomarkers, Type 2 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 23 May 2017 (actual)
- Primary completion
- 28 May 2020 (actual)
- Study completion
- 28 May 2020 (actual)
- First posted
- 1 Nov 2022 (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.
This study is a retrospective case-control study. In this study, through untargeted metabolomics, investigators identified several specific changed serum metabolites in T2DM patients with or without AMI and their functions/category. Moreover, researchers selected several endogenous candidate biomarkers with larger fold change for validation in expanded population to find biomarkers which effectively predict the development of STEMI in patients with T2DM.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Device: liquid chromatography-mass spectrometry (LC/MS) analysisin the group, the participants exhibited negative results or <50% obstruction upon coronary artery CT or coronary angiography. The group did not have coronary heart disease and diabetes |
| T2DM group | – | Device: liquid chromatography-mass spectrometry (LC/MS) analysisin the group, the participants exhibited negative results or <50% obstruction upon coronary artery CT or coronary angiography. The group did not have coronary heart disease but have type 2 diabetes mellitus. |
| T2DM+AMI group | – | Device: liquid chromatography-mass spectrometry (LC/MS) analysisIn the group, we eventually recruited 30 adult patients who were firstly diagnosed ST-elevation myocardial infarction (STEMI) within 12 hours of appearance chest pains or other AMI symptoms and had no previous history of coronary artery disease (CAD). Peripheral venous blood samples were drawn from subjects on admission or prior to coronary revascularization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ① Patients with acute ST-segment elevation myocardial infarction (STEMI) who underwent emergency PCI in Beijing Friendship Hospital (Xicheng District) affiliated to Capital Medical University. ②In the Beijing Friendship Hospital (Xicheng District) affiliated to Capital Medical University, coronary angiography showed negative coronary angiography or coronary artery CT showed <50% obstruction in patients with non-coronary heart disease.
Key inclusion criteria (4 listed)
- STEMI patients meet the diagnostic criteria of "Guidelines for the Diagnosis and Treatment of Acute ST-segment Elevation Myocardial Infarction (2015)".
- STMEI patients undergoing emergency PCI should undergo emergency PCI within 12 hours of onset at Beijing Friendship Hospital affiliated to Capital Medical University.
- All diabetic patients meet the diagnostic criteria for type 2 diabetes.
- They agreed to be enrolled in the trial and signed the informed consent.
Key exclusion criteria (3 listed)
- Combined with severe valvular disease or congenital heart disease, hypertension, chronic kidney disease, stroke, hyperlipidemia, previous history of coronary artery disease.
- Involved in acute infection, severe hepatic dysfunction, tumor, rheumatic immune disease.
- Incomplete clinical information.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liquid chromatography-mass spectrometry (LC/MS) analysisTo obtain a complete metabolic profile, untargeted metabolomics analysis was conducted by using UPLC-MS. Chromatographic separation was accomplished in an Thermo Vanquish system equipped with an ACQUITY UPLC®HSS T3 (150×2.1 mm, 1.8 µm, Waters, USA) column maintained at 40 ℃. The temperature of the autosampler was 8 ℃. The ESI-MSn experiments were executed on the Thermo Q Exactive mass spectrometer with the spray voltage of 3.5 kV and -2.5 kV in positive and negative modes, respectively. The capillary temperature was 325℃. The analyzer scanned over a mass range of m/z 81-1 000 for full scan at a mass resolution of 70 000. The normalized collision energy was 30 eV(19606840). The detected ions were all under isotopic calibration with the accurate masses of the reference standards. | Device | Control group, T2DM group, T2DM+AMI group |
Primary outcome
There are differences in the metabolic profile of diabetic patients with or without combined acute myocardial infarction
Time frame: December 16th, 2020
About 10ml of venous blood was collected on the admission, serum was separated. To obtain a complete metabolic profile, untargeted metabolomics analysis was conducted by using UPLC-MS.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Individual participant dataSharing planned: No
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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.
Weiping Li, MD study director
Beijing Friendship 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 STEMI, run by Beijing Friendship 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 1 Nov 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
There are differences in the metabolic profile of diabetic patients with or without combined acute myocardial infarction (time frame: December 16th, 2020). 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 1 Nov 2022.