BiomarkersNCT05138731
Metabolomics Profiling of Coronary Heart Disease
An observational study of Biomarkers, run by General Hospital of Ningxia Medical University at 5 sites in China.
Trial summary
This study sought to assess the diagnostic and prognostic values of metabolomics in coronary artery disease(CAD). Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Biomarkers
- What is being tested?
- treatments according guidelines
- How many people
- 821 participants
- Where
- 5 sitesChina
- Study dates
- 1 Oct 2020to 30 May 2023
- 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 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: About 821 subjects will be recruited from 5 centers in different hospitals.
Who may be able to join
- 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%
Who cannot join
- Older than 80 years and younger than 18 years old,
- Aortic dissection
- Pulmonary embolism
- Malignant tumor
- Autoimmune diseases
- Systemic systemic diseases
Show all 12Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Department of Cardiovascular Internal Disease, Guyuan People's Hospital of Ningxia Autonomous Region
Guyuan, Ningxia, 756000
Yanning Zhang, M.A, +8613309545199
- Recruiting
Fifth People's Hospital of Ningxia Autonomous Region
Shizuishan, Ningxia, 753000
Fuqing Ma, M.A, +8617709586346
- Recruiting
Affiliated Cardio-Cerebrovascular Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750000
Fang Liu, M.A, +8618609519633
- Recruiting
People's Hospital of Ningxia Hui Autonomous Region
Yinchuan, Ningxia, 750000
Shaojing Xi, M.A, +8618295107706
- Recruiting
Department of Cardiaovascular Internal Disease, General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
Jun He, Ph.D, MD, +8613995273232, junhe@nxmu.edu.cn
Jun He, Ph.D, MD
About this study
Official title: LC-MS Based Metabolomics Study of Coronary Heart Disease: Diagnostic and Prognostic Value of Metabolites
This study sought to assess the diagnostic and prognostic values of metabolomics in coronary artery disease(CAD).
Read the detailed 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.
- Conditions
- Biomarkers
- Being tested
- treatments according guidelines
- Keywords
- metabolomics, biomarkers, liquid chromatography-mass spectrometry, coronary artery disease, serum, urine
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treatments according guidelinesOther
different group intervened with different treatment following guidelines/consensuses accordingly
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: treatments according guidelines | |
| 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. Receives: Other: treatments according guidelines | |
| 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. Receives: Other: treatments according guidelines | |
| 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. Receives: Other: treatments according guidelines | |
| 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) Receives: Other: treatments according guidelines | |
| nonobstructive coronary atherosclerosis （NOCA） | stenosis < 50% in coronary arteries Receives: Other: treatments according guidelines | |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
A composite of death from cardiovascular causes in patients with CAD
Measured: Follow-up is expected to end on December 30, 2022
Secondary outcomes (1)
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.
Measured: Follow-up is expected to end on December 30, 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start1 Oct 2020
- Primary completion30 Jan 2023 (estimated)
- Study completion30 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for BiomarkersStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 821 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun He, General Hospital of Ningxia Medical University
- Investigators
- Hechun Xia, MA, Study chair, General Hospital of Ningxia Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138731
- Sponsor's protocol ID
- JH
- Status last verified
- Dec 2021
- First submitted
- 17 Nov 2021
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31378756Vaarhorst 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.
PubMed 24952859Cavus 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.
PubMed 31664431McGarrah 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.
PubMed 29700070Fan 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.
PubMed 27634119Hilvo 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.
PubMed 31209498Qin 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.
PubMed 32997403Zhang 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.
PubMed 29212895
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LC-MS Based Metabolomics Study of Coronary Heart Disease: Diagnostic and Prognostic Value of Metabolites
- ClinicalTrials.gov ID
- NCT05138731
- Acronym / sponsor ID
- JH
- Conditions
- Biomarkers
- Keywords
- metabolomics, biomarkers, liquid chromatography-mass spectrometry, coronary artery disease, serum, urine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 821 participants (estimated)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Jan 2023 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 1 Dec 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.
This study sought to assess the diagnostic and prognostic values of metabolomics in coronary artery disease(CAD).
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Stable angina (SA) | – | Other: treatments according guidelinesTypical 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. |
| Unstable angina (UA） | – | Other: treatments according guidelinesIncluding 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. |
| Acute non-ST-segment elevation myocardial infarction （NSTEMI） | – | Other: treatments according guidelinesPatients 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. |
| Acute ST-segment elevation myocardial infarction （STEMI） | – | Other: treatments according guidelinesTroponin 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. |
| normal coronary artery （NCA） | – | Other: treatments according guidelinessymptoms of chest pain and no stenosis in coronary arteries (such as myocardial bridging, reflux esophagitis, intercostals neuralgia, cervical spondylopathy, and unexplained chest pain) |
| nonobstructive coronary atherosclerosis （NOCA） | – | Other: treatments according guidelinesstenosis < 50% in coronary arteries |
| 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 |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- About 821 subjects will be recruited from 5 centers in different hospitals.
Key inclusion criteria (4 listed)
- 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%
Key exclusion criteria (12 listed)
- Older than 80 years and younger than 18 years old,
- Aortic dissection
- Pulmonary embolism
- Malignant tumor
- Autoimmune diseases
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 |
|---|---|---|
| treatments according guidelinesdifferent group intervened with different treatment following guidelines/consensuses accordingly | Other | Acute ST-segment elevation myocardial infarction （STEMI）, Acute non-ST-segment elevation myocardial infarction （NSTEMI）, Stable angina (SA), Unstable angina (UA）, nonobstructive coronary atherosclerosis （NOCA）, normal coronary artery （NCA） |
Primary outcome
Death
Time frame: Follow-up is expected to end on December 30, 2022
A composite of death from cardiovascular causes in patients with CAD
1 secondary outcome
Major adverse cardiovascular events
Time frame: Follow-up is expected to end on December 30, 2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- Background: PubMed 31378756Iida 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.
- Background: PubMed 24952859Vaarhorst 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.
- Background: PubMed 31664431Cavus 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.
- Background: PubMed 29700070McGarrah 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.
- Background: PubMed 27634119Fan 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.
- Background: PubMed 31209498Hilvo 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.
- Background: PubMed 32997403Qin 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.
- Background: PubMed 29212895Zhang 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.
- Application of Metabolomics to Epidemiological Studies of Atherosclerosis and Cardiovascular DiseaseLink provided by the sponsor.
- ComprehensiveMetabolomicCharacterization of Coronary Artery DiseasesLink provided by the sponsor.
- 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.
Hechun Xia, MA study chair
General Hospital of Ningxia Medical University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biomarkers, run by General Hospital of Ningxia Medical University at 5 sites 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 12 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 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 Jun He, Ph. D, MD (+8613995273232, junhe@nxmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: Follow-up is expected to end on December 30, 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05138731, which also lists 8 linked publications.
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 14 Jan 2022.