Cardiovascular DiseasesNCT03345927
Plasma S-adenosylhomocysteine Levels and Endothelial Dysfunction
An observational study of Cardiovascular Diseases, run by Shenzhen Center for Disease Control and Prevention at 1 site in China.
Trial summary
To investigate the relationship betweeen plasma S-adenosylhomocysteine (SAH) levels and endothelial dysfunction, we plan to enroll approximately 150 patients with high risk of cardiovascualr disease,who will be measaured the flow-mediated dilation by B-ultrasound, and then measaured the plasma levels of methionine… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cardiovascular Diseases
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 4 Dec 2017to 30 Apr 2018
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: patients with high cardiovascular risk, or diagnosed as coronary artery disease.
Who may be able to join
- patients who have stable clinical conditions, except for acute coronary syndromes, and the availability of measurement of flow-mediated dilation, or have more than three cardiovascular traditional risk factors, such as smoking, alcohol use, obesity, hypertesion, diabetes, family history, and so on.
Who cannot join
- critical illness or hemodynamic instability other than acute coronary syndromes, surgery, or trauma within the previous month, known cancer, hepatic failure or hepatitis, or the use of drugs, such as anticancer agents, which would affect plasma tHcy concen-trations.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Association Between Plasma S-adenosylhomocysteine Levels and Endothelial Dysfunction in Cardiovascular Disease Patients
To investigate the relationship betweeen plasma S-adenosylhomocysteine (SAH) levels and endothelial dysfunction, we plan to enroll approximately 150 patients with high risk of cardiovascualr disease,who will be measaured the flow-mediated dilation by B-ultrasound, and then measaured the plasma levels of methionine metabolites, such as SAH, SAM, and analyze the association.
Read the detailed description
To investigate the relationship betweeen plasma S-adenosylhomocysteine (SAH) levels and endothelial dysfunction, we plan to enroll approximately 150 patients with high risk of cardiovascualr disease,who will be measaured the flow-mediated dilation by B-ultrasound, and then use HPLC-MS/MS to measaure the plasma levels of methionine metabolites, such as SAH, SAM, and use methylated specifical PCR to detect the promoter DNA methylation of p66shc, and use ELISA kits to measure the plasma ROS levels of CVD patients, such as MDA, 8-iso-prostaglandin F2a, and finally analyze the association between SAH, ROS levels, promoter DNA methylation of p66shc, and flow-mediated dilation.
- Conditions
- Cardiovascular Diseases
- Being tested
- no intervention
- Keywords
- S-adenosylhomocysteine, Endothelial function
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| high cardiovascular risk group | no intervention Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial function
measurement of flow-mediated dilation by B ultrasound
Measured: one month after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start4 Dec 2017
- Primary completion30 Mar 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen Center for Disease Control and Prevention
- Sponsor type
- Other government
- Collaborators
- Peking University Shenzhen Hospital
- Responsible party
- Principal investigator, Yunjun Xiao, Shenzhen Center for Disease Control and Prevention
- Investigators
- Yuebin Ke, Dr., Study director, Shenzhen CDC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03345927
- Sponsor's protocol ID
- ShenzhenCDC
- Status last verified
- Mar 2021
- First submitted
- 14 Nov 2017
- Last updated
- 17 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Xiao Y, Xia J, Cheng J, Huang H, Zhou Y, Yang X, Su X, Ke Y, Ling W. Inhibition of S-Adenosylhomocysteine Hydrolase Induces Endothelial Dysfunction via Epigenetic Regulation of p66shc-Mediated Oxidative Stress Pathway. Circulation. 2019 May 7;139(19):2260-2277. doi: 10.1161/CIRCULATIONAHA.118.036336.
PubMed 30773021
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Association Between Plasma S-adenosylhomocysteine Levels and Endothelial Dysfunction in Cardiovascular Disease Patients
- ClinicalTrials.gov ID
- NCT03345927
- Acronym / sponsor ID
- ShenzhenCDC
- Conditions
- Cardiovascular Diseases
- Keywords
- S-adenosylhomocysteine, Endothelial function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Shenzhen Center for Disease Control and PreventionOther government
- Collaborators
- Peking University Shenzhen Hospital
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 17 Nov 2017 (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.
To investigate the relationship betweeen plasma S-adenosylhomocysteine (SAH) levels and endothelial dysfunction, we plan to enroll approximately 150 patients with high risk of cardiovascualr disease,who will be measaured the flow-mediated dilation by B-ultrasound, and then measaured the plasma levels of methionine metabolites, such as SAH, SAM, and analyze the association.
Detailed description
To investigate the relationship betweeen plasma S-adenosylhomocysteine (SAH) levels and endothelial dysfunction, we plan to enroll approximately 150 patients with high risk of cardiovascualr disease,who will be measaured the flow-mediated dilation by B-ultrasound, and then use HPLC-MS/MS to measaure the plasma levels of methionine metabolites, such as SAH, SAM, and use methylated specifical PCR to detect the promoter DNA methylation of p66shc, and use ELISA kits to measure the plasma ROS levels of CVD patients, such as MDA, 8-iso-prostaglandin F2a, and finally analyze the association between SAH, ROS levels, promoter DNA methylation of p66shc, and flow-mediated dilation.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| high cardiovascular risk group | – | Other: no interventionno intervention |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patients with high cardiovascular risk, or diagnosed as coronary artery disease.
Key inclusion criteria (1 listed)
- patients who have stable clinical conditions, except for acute coronary syndromes, and the availability of measurement of flow-mediated dilation, or have more than three cardiovascular traditional risk factors, such as smoking, alcohol use, obesity, hypertesion, diabetes, family history, and so on.
Key exclusion criteria (1 listed)
- critical illness or hemodynamic instability other than acute coronary syndromes, surgery, or trauma within the previous month, known cancer, hepatic failure or hepatitis, or the use of drugs, such as anticancer agents, which would affect plasma tHcy concen-trations.
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 |
|---|---|---|
| no interventionno intervention | Other | high cardiovascular risk group |
Primary outcome
Endothelial function
Time frame: one month after enrollment
measurement of flow-mediated dilation by B ultrasound
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 17 Mar 2021.
- Derived from this study: PubMed 30773021Xiao Y, Xia J, Cheng J, Huang H, Zhou Y, Yang X, Su X, Ke Y, Ling W. Inhibition of S-Adenosylhomocysteine Hydrolase Induces Endothelial Dysfunction via Epigenetic Regulation of p66shc-Mediated Oxidative Stress Pathway. Circulation. 2019 May 7;139(19):2260-2277. doi: 10.1161/CIRCULATIONAHA.118.036336.
- Individual participant dataSharing planned: Undecided
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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.
Yuebin Ke, Dr. study director
Shenzhen CDC
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 Cardiovascular Diseases, run by Shenzhen Center for Disease Control and Prevention 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 1 inclusion and 1 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 17 Mar 2021. 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?
Endothelial function (time frame: one month after enrollment). 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 NCT03345927, which also lists 1 linked publication.
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 17 Mar 2021.