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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05601310
Other study ID # BFH-Metabolomics and STEMI
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 23, 2017
Est. completion date May 28, 2020

Study information

Verified date October 2022
Source Beijing Friendship Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 82
Est. completion date May 28, 2020
Est. primary completion date May 28, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Intervention

Device:
liquid chromatography-mass spectrometry (LC/MS) analysis
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.

Locations

Country Name City State
China Weiping Li Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. December 16th, 2020
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