NCT03462277

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 12, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

July 17, 2019

Status Verified

July 1, 2019

Enrollment Period

7 months

First QC Date

March 6, 2018

Last Update Submit

July 16, 2019

Conditions

Keywords

methylationhydroxymethylationatherosclerosiscoronary heart disease

Outcome Measures

Primary Outcomes (1)

  • DNA Methylation and Hydroxymethylation Levels

    Collection of blood samples and measuring the samples by PCR and ELISA

    1 month

Study Arms (2)

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.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Coronary Heart Disease and Patients without Coronary Heart Disease. All patients underwent carotid ultrasound and coronary angiograms.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

human blood samples, human aortic tissues

MeSH Terms

Conditions

Coronary DiseaseAtherosclerosis

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Dongying Zhang, doctor

    First Affiliated Hospital of Chongqing Medical University

    STUDY DIRECTOR
  • Dan Jiang

    First Affiliated Hospital of Chongqing Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

March 6, 2018

First Posted

March 12, 2018

Study Start

January 1, 2018

Primary Completion

August 1, 2018

Study Completion

October 1, 2018

Last Updated

July 17, 2019

Record last verified: 2019-07

Locations