Metabolomics Profiling of Coronary Heart Disease

Biomarkers Clinical Trial

Official title:

LC-MS Based Metabolomics Study of Coronary Heart Disease: Diagnostic and Prognostic Value of Metabolites

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05138731
• Other study ID #: JH
• Status: Recruiting
• Start date: October 1, 2020
• Est. completion date: May 30, 2023

Study information

• Verified date: December 2021
• Source: General Hospital of Ningxia Medical University
• Contact: Jun He, Ph. D, MD
• Phone: +8613995273232
• Email: junhe[@]nxmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study sought to assess the diagnostic and prognostic values of metabolomics in coronary artery disease(CAD).

Description:

The purpose of this study is to establish a powerful diagnostic and prognostic model based on metabolites in CAD patients.A total of 821 hospitalized patients with CAD and 200 healthy volunteers are enrolled.Specifically, 200 CAD patients from single-centre are regarded as discovery set, 300 CAD patients from multicentre are regarded as validation set. A third independent set including 321patitents is regarded as application set. Untargeted and targeted metabolomics analysis about serum and urine samples in all subjects will be performed using high-performance liquid chromatography coupled with mass spectrometry technology. Univariate and multivariate analysis methods are used to extract and analyze the differential mebabolites. By exploring the relationship between the differential mebabolites and clinical manifestions, a set of diagnostic biomarkers for CAD will be identified. By elucidating the correlation between the differential mebabolites and MACEs, a effective prognostic model will be established. Adverse events are defined as the combined endpoints of death or major adverse cardiovascular events(MACEs) in patients with CAD for at least 1 year follow-up after discharge. In brief, we aim to establish valuabe diagnostic and predictive models based on novel baseline metabolites in patients with CAD.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 821
• Est. completion date: May 30, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

Inclusion Criteria:

• Objective evidence of coronary heart disease risk factors

• Or angina pectoris symptoms

• Or ECG ischemic changes

• Or elevated myocardial enzymes, myocardial radionuclide scanning showing myocardial filling defect, coronary CT showing coronary stenosis = 50%

Exclusion Criteria:

• Older than 80 years and younger than 18 years old,

• Aortic dissection

• Pulmonary embolism

• Malignant tumor

• Autoimmune diseases

• Systemic systemic diseases

• Severe infectious diseases

• Trauma, surgery in the last three months

• Myocarditis, cardiomyopathy, pericarditis, severe congenital heart disease

• Syphilis

• Human immunodeficiency virus / acquired immunodeficiency syndrome

• Hepatitis B and hepatitis C

Related Conditions & MeSH terms

• Biomarkers
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Other:
• treatments according guidelines
different group intervened with different treatment following guidelines/consensuses accordingly

Locations

Country	Name	City	State
China	Department of Cardiovascular Internal Disease, Guyuan People's Hospital of Ningxia Autonomous Region	Guyuan	Ningxia
China	Fifth People's Hospital of Ningxia Autonomous Region	Shizuishan	Ningxia
China	Affiliated Cardio-Cerebrovascular Hospital of Ningxia Medical University	Yinchuan	Ningxia
China	Department of Cardiaovascular Internal Disease, General Hospital of Ningxia Medical University	Yinchuan	Ningxia
China	People's Hospital of Ningxia Hui Autonomous Region	Yinchuan	Ningxia

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Ningxia Medical University

Country where clinical trial is conducted

China, 

References & Publications (8)

Cavus E, Karakas M, Ojeda FM, Kontto J, Veronesi G, Ferrario MM, Linneberg A, Jørgensen T, Meisinger C, Thorand B, Iacoviello L, Börnigen D, Woodward M, Schnabel R, Costanzo S, Tunstall-Pedoe H, Koenig W, Kuulasmaa K, Salomaa V, Blankenberg S, Zeller T; BiomarCaRE consortium. Association of Circulating Metabolites With Risk of Coronary Heart Disease in a European Population: Results From the Biomarkers for Cardiovascular Risk Assessment in Europe (BiomarCaRE) Consortium. JAMA Cardiol. 2019 Dec 1;4(12):1270-1279. doi: 10.1001/jamacardio.2019.4130. — View Citation

Fan Y, Li Y, Chen Y, Zhao YJ, Liu LW, Li J, Wang SL, Alolga RN, Yin Y, Wang XM, Zhao DS, Shen JH, Meng FQ, Zhou X, Xu H, He GP, Lai MD, Li P, Zhu W, Qi LW. Comprehensive Metabolomic Characterization of Coronary Artery Diseases. J Am Coll Cardiol. 2016 Sep 20;68(12):1281-93. doi: 10.1016/j.jacc.2016.06.044. — View Citation

Hilvo M, Meikle PJ, Pedersen ER, Tell GS, Dhar I, Brenner H, Schöttker B, Lääperi M, Kauhanen D, Koistinen KM, Jylhä A, Huynh K, Mellett NA, Tonkin AM, Sullivan DR, Simes J, Nestel P, Koenig W, Rothenbacher D, Nygård O, Laaksonen R. Development and validation of a ceramide- and phospholipid-based cardiovascular risk estimation score for coronary artery disease patients. Eur Heart J. 2020 Jan 14;41(3):371-380. doi: 10.1093/eurheartj/ehz387. — View Citation

Iida M, Harada S, Takebayashi T. Application of Metabolomics to Epidemiological Studies of Atherosclerosis and Cardiovascular Disease. J Atheroscler Thromb. 2019 Sep 1;26(9):747-757. doi: 10.5551/jat.RV17036. Epub 2019 Aug 2. Review. — View Citation

McGarrah RW, Crown SB, Zhang GF, Shah SH, Newgard CB. Cardiovascular Metabolomics. Circ Res. 2018 Apr 27;122(9):1238-1258. doi: 10.1161/CIRCRESAHA.117.311002. Review. — View Citation

Qin M, Zhu Q, Lai W, Ma Q, Liu C, Chen X, Zhang Y, Wang Z, Chen H, Yan H, Lei H, Zhang S, Dong X, Wang H, Huang M, Lian Q, Zhong S. Insights into the prognosis of lipidomic dysregulation for death risk in patients with coronary artery disease. Clin Transl Med. 2020 Sep;10(5):e189. doi: 10.1002/ctm2.189. — View Citation

Vaarhorst AA, Verhoeven A, Weller CM, Böhringer S, Göraler S, Meissner A, Deelder AM, Henneman P, Gorgels AP, van den Brandt PA, Schouten LJ, van Greevenbroek MM, Merry AH, Verschuren WM, van den Maagdenberg AM, van Dijk KW, Isaacs A, Boomsma D, Oostra BA, van Duijn CM, Jukema JW, Boer JM, Feskens E, Heijmans BT, Slagboom PE. A metabolomic profile is associated with the risk of incident coronary heart disease. Am Heart J. 2014 Jul;168(1):45-52.e7. doi: 10.1016/j.ahj.2014.01.019. Epub 2014 Apr 4. — View Citation

Zhang L, Wei TT, Li Y, Li J, Fan Y, Huang FQ, Cai YY, Ma G, Liu JF, Chen QQ, Wang SL, Li H, Alolga RN, Liu B, Zhao DS, Shen JH, Wang XM, Zhu W, Li P, Qi LW. Functional Metabolomics Characterizes a Key Role for N-Acetylneuraminic Acid in Coronary Artery Diseases. Circulation. 2018 Mar 27;137(13):1374-1390. doi: 10.1161/CIRCULATIONAHA.117.031139. Epub 2017 Dec 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death	A composite of death from cardiovascular causes in patients with CAD	Follow-up is expected to end on December 30, 2022
Secondary	Major adverse cardiovascular events	Hospitalization for recurrent severe angina pectoris, acute myocardial infarction, revascularization, malignant arrhythmia, new heart failure or acute attack of chronic heart failure, cardiac arrest and stroke.	Follow-up is expected to end on December 30, 2022

External Links

•   A metabolomic profile is associated with the risk of incident coronary heart disease
•   Application of Metabolomics to Epidemiological Studies of Atherosclerosis and Cardiovascular Disease
•   Association of Circulating Metabolites With Risk of Coronary Heart Disease in a European Population Results From the Biomarkers for Cardiovascular Risk Assessment in Europe (BiomarCaRE) Consortium
•   Cardiovascular Metabolomics
•   ComprehensiveMetabolomicCharacterization of Coronary Artery Diseases
•   Development and validation of a ceramide- and phospholipid-based cardiovascular risk estimation score for coronary artery disease patients
•   Functional Metabolomics Characterizes a Key Role for N-Acetylneuraminic Acid in Coronary Artery Diseases
•   Insights into the prognosis of lipidomic dysregulation for death risk in patients with coronary artery disease.