Plasma S-adenosylhomocysteine Levels and Endothelial Dysf... | NCT03345927

Studies
Plasma S-adenosylhomocysteine Levels and Endothelial Dysfunction

NCT03345927

Sponsor

Shenzhen Center for Disease Control and Prevention

Status

Completed

Last Update Posted

Mar 17, 2021Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Cardiovascular Diseases

Interventions

no intervention

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 4, 2017Actual

Primary Completion Date

Mar 30, 2018Actual

Completion Date

Apr 30, 2018Actual

First Submitted Date

Nov 14, 2017

First Submission Date that Met QC Criteria

Nov 14, 2017

First Posted Date

Nov 17, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 15, 2021

Last Update Posted Date

Mar 17, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yunjun Xiao, Principal Investigator, Shenzhen Center for Disease Control and PreventionPrincipal Investigator

Lead Sponsor

Shenzhen Center for Disease Control and PreventionOTHER_GOV

Collaborators

Name	Class
Peking University Shenzhen Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
high cardiovascular risk group		no intervention	Other: no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	no intervention	high cardiovascular risk group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Endothelial function	measurement of flow-mediated dilation by B ultrasound	one month after enrollment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

patients with high cardiovascular risk, or diagnosed as coronary artery disease.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yuebin Ke, Dr.	Shenzhen CDC	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chun Wang		Shenzhen	Guangdong	518055	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30773021	Derived	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.