Metabolomics Profiling of Coronary Heart Disease

NCT ID: NCT05138731

Last Updated: 2022-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

821 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-01

Study Completion Date

2023-05-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Biomarkers

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Stable angina (SA)

Typical chronic exersive angina pectoris attacks, lasting several minutes to more than 10 minutes, 3-5 minutes in most cases, generally not more than 30 minutes. The pain disappeared after rest or taking nitrates, and the pain degree, frequency, duration, nature and inducing factors did not change in the last 1-3 months.

treatments according guidelines

Intervention Type OTHER

different group intervened with different treatment following guidelines/consensuses accordingly

Unstable angina (UA)

Including resting angina (attack at rest, the duration is usually \>20 minutes), primary angina (usually the first symptoms within 1-2 months, very light physical activity can be induced, at least CCSIII level), worsening angina (angina gradually increases on the basis of relatively stable labor angina. More severe pain, longer or more frequent pain, at least grade I increase according to THE CCS classification, at least GRADE II CCSI). TNI was negative, routine electrocardiogram may have transient ST segment depression, T wave low flat or inverted.

treatments according guidelines

Intervention Type OTHER

different group intervened with different treatment following guidelines/consensuses accordingly

Acute non-ST-segment elevation myocardial infarction (NSTEMI)

Patients with elevated troponin accompanied by one or more of the following conditions: electrocardiogram showed new ST segment depression or T wave flatness or inversion; Persistent ischemic chest pain; Echocardiography showed abnormal segmental ventricular wall activity. Abnormal coronary angiography.

treatments according guidelines

Intervention Type OTHER

different group intervened with different treatment following guidelines/consensuses accordingly

Acute ST-segment elevation myocardial infarction (STEMI)

Troponin was elevated, and ECG showed ST segment arcuate back elevation, accompanied by one or more of the following conditions: persistent ischemic chest pain; Echocardiography showed segmental abnormal ventricular wall activity; Abnormal coronary angiography.

treatments according guidelines

Intervention Type OTHER

different group intervened with different treatment following guidelines/consensuses accordingly

normal coronary artery (NCA)

symptoms of chest pain and no stenosis in coronary arteries (such as myocardial bridging, reflux esophagitis, intercostals neuralgia, cervical spondylopathy, and unexplained chest pain)

treatments according guidelines

Intervention Type OTHER

different group intervened with different treatment following guidelines/consensuses accordingly

nonobstructive coronary atherosclerosis (NOCA)

stenosis \< 50% in coronary arteries

treatments according guidelines

Intervention Type OTHER

different group intervened with different treatment following guidelines/consensuses accordingly

healthy volunteers

Healthy control subjects who had no significant systemic diseases (e.g. ischemic heart disease, hypertension,diabetes,cancer, pulmonary disease, or infectious diseases) were recruited from Physical Examination Center of Ningxia Medical University General Hospital

No interventions assigned to this group

Interventions

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treatments according guidelines

different group intervened with different treatment following guidelines/consensuses accordingly

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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General Hospital of Ningxia Medical University

OTHER

Sponsor Role lead

Responsible Party

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Jun He

vice director of the department of cardiovascular internal medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hechun Xia, MA

Role: STUDY_CHAIR

General Hospital of Ningxia Medical University

Locations

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Department of Cardiovascular Internal Disease, Guyuan People's Hospital of Ningxia Autonomous Region

Guyuan, Ningxia, China

Site Status RECRUITING

Fifth People's Hospital of Ningxia Autonomous Region

Shizuishan, Ningxia, China

Site Status RECRUITING

Affiliated Cardio-Cerebrovascular Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Site Status RECRUITING

People's Hospital of Ningxia Hui Autonomous Region

Yinchuan, Ningxia, China

Site Status RECRUITING

Department of Cardiaovascular Internal Disease, General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jun He, Ph. D, MD

Role: CONTACT

+8613995273232

Meijiao Fu, MA

Role: CONTACT

+8613723376077

Facility Contacts

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Yanning Zhang, M.A

Role: primary

+8613309545199

Fuqing Ma, M.A

Role: primary

+8617709586346

Fang Liu, M.A

Role: primary

+8618609519633

Shaojing Xi, M.A

Role: primary

+8618295107706

Jun He, Ph.D, MD

Role: primary

+8613995273232

References

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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.

Reference Type BACKGROUND
PMID: 31378756 (View on PubMed)

Vaarhorst AA, Verhoeven A, Weller CM, Bohringer S, Goraler 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.

Reference Type BACKGROUND
PMID: 24952859 (View on PubMed)

Cavus E, Karakas M, Ojeda FM, Kontto J, Veronesi G, Ferrario MM, Linneberg A, Jorgensen T, Meisinger C, Thorand B, Iacoviello L, Bornigen 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.

Reference Type BACKGROUND
PMID: 31664431 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29700070 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27634119 (View on PubMed)

Hilvo M, Meikle PJ, Pedersen ER, Tell GS, Dhar I, Brenner H, Schottker B, Laaperi M, Kauhanen D, Koistinen KM, Jylha A, Huynh K, Mellett NA, Tonkin AM, Sullivan DR, Simes J, Nestel P, Koenig W, Rothenbacher D, Nygard 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.

Reference Type BACKGROUND
PMID: 31209498 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32997403 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29212895 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://doi.org/10.5551/jat.RV17036

Application of Metabolomics to Epidemiological Studies of Atherosclerosis and Cardiovascular Disease

http://hub.pubmedplus.com/10.1016/j.ahj.2014.01.019

A metabolomic profile is associated with the risk of incident coronary heart disease

http://hub.pubmedplus.com/10.1001/jamacardio.2019.4130

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

http://dx.doi.org/10.1016/j.jacc.2016.06.044

ComprehensiveMetabolomicCharacterization of Coronary Artery Diseases

http://hub.pubmedplus.com/10.1093/eurheartj/ehz387

Development and validation of a ceramide- and phospholipid-based cardiovascular risk estimation score for coronary artery disease patients

http://hub.pubmedplus.com/10.1002/ctm2.189

Insights into the prognosis of lipidomic dysregulation for death risk in patients with coronary artery disease.

http://hub.pubmedplus.com/10.1161/circulationaha.117.031139

Functional Metabolomics Characterizes a Key Role for N-Acetylneuraminic Acid in Coronary Artery Diseases

Other Identifiers

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JH

Identifier Type: -

Identifier Source: org_study_id

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