NCT03345927

Brief 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 metabolites, such as SAH, SAM, and analyze the association.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
17 days until next milestone

Study Start

First participant enrolled

December 4, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

4 months

First QC Date

November 14, 2017

Last Update Submit

March 15, 2021

Conditions

Cardiovascular Diseases

Keywords

S-adenosylhomocysteineEndothelial function

Outcome Measures

Primary Outcomes (1)

  • Endothelial function

    measurement of flow-mediated dilation by B ultrasound

    one month after enrollment

Study Arms (1)

high cardiovascular risk group

no intervention

Other: no intervention

Interventions

no interventionOTHER

no intervention

high cardiovascular risk group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chun Wang

Shenzhen, Guangdong, 518055, China

Location

Related Publications (1)

  • 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.

    PMID: 30773021DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

10mL plasma

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Yuebin Ke, Dr.

    Shenzhen CDC

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 14, 2017

First Posted

November 17, 2017

Study Start

December 4, 2017

Primary Completion

March 30, 2018

Study Completion

April 30, 2018

Last Updated

March 17, 2021

Record last verified: 2021-03

Locations

CN(1)