DNA Methylation and Hydroxymethylation Levels in Patients... | NCT03462277

Studies
DNA Methylation and Hydroxymethylation Levels in Patients With Coronary Heart Disease

NCT03462277

Sponsor

Chongqing Medical University

Status

Completed

Last Update Posted

Jul 17, 2019Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Coronary Heart Disease

Interventions

Not provided

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

Jul 2019

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

Jan 1, 2018Actual

Primary Completion Date

Aug 1, 2018Actual

Completion Date

Oct 1, 2018Actual

First Submitted Date

Mar 6, 2018

First Submission Date that Met QC Criteria

Mar 9, 2018

First Posted Date

Mar 12, 2018Actual

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

Jul 16, 2019

Last Update Posted Date

Jul 17, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The purpose of this trial is to investigate the relationship between DNA methylation and hydroxymethylation and the expression of DNMTs, TET family gene and the degree of coronary heart disease.

Detailed Description

To determine the levels of DNA methylation and hydroxymethylation with coronary heart disease.
To investigate the relationship between DNA methylation and hydroxymethylation and the degree of coronary atherosclerosis.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control group		Control group was defined as people with negative findings in coronary angiograms.
Coronary Heart Disease group		CHD patients was defined as at least one lesion in a coronary artery or branches in coronary angiograms.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
DNA Methylation and Hydroxymethylation Levels	Collection of blood samples and measuring the samples by PCR and ELISA	1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male and Female. Patients older than 65 years old who are willing to participate in the study. CHD patients was defined as at least one lesion in a coronary artery or branches in coronary angiograms. Control group was defined as people with negative findings in coronary angiograms.

Exclusion Criteria:

Patients with concurrent infection or any documented inflammatory illness, such as arthritis or connective tissue diseases, or any other malignancy. Patients with a history of cardiomyopathy. Pregnant women. Severe hepatic dysfunction or End-stage renal failure. Uncontrolled hypertension.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Patients with Coronary Heart Disease and Patients without Coronary Heart Disease.

All patients underwent carotid ultrasound and coronary angiograms.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dongying Zhang, doctor	First Affiliated Hospital of Chongqing Medical University	Study Director
Dan Jiang	First Affiliated Hospital of Chongqing Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital of Chongqing Medical University		Chongqing			China

Condition Browse Module

MeSH Terms

ID	Term
D003327	Coronary Disease
D050197	Atherosclerosis

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided