NCT02500823

Brief Summary

Compelling epidemiological evidence indicates that alterations of mitochondrial DNA, including mutations and abnormal content of mitochondrial DNA (mtDNA), are associated with the initiation and development of cardiovascular disease. This study was undertaken to investigate whether mtDNA copy number in peripheral blood cells could be used as a risk predictor for coronary heart disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

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

Study Start

First participant enrolled

April 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 17, 2015

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

May 17, 2016

Status Verified

May 1, 2016

Enrollment Period

4 months

First QC Date

July 15, 2015

Last Update Submit

May 14, 2016

Conditions

Coronary Heart Disease

Keywords

Mitochondrial DNA copy numberPeripheral blood cells

Outcome Measures

Primary Outcomes (1)

  • Relative copy number of mitochondrial DNA

    The ratio of mitochondrial DNA copy number to hemoglobin copy number was calculated for each sample from standard curves. After that, the ratio for each sample was normalized to a calibrator DNA in order to standardize between different runs, and then defined as the measurement of relative mtDNA copy number.Relative copy number of Mitochondrial DNA were measured in CHD patients in comparison to control group.

    From date of percutaneous coronary intervention until the date of discharging from hospital, assessed up to 5 days

Study Arms (2)

CHD group

200 consecutive patients were recruited, who have diagnosed with coronary heart disease(CHD) by coronary angiography.

Control group

The 200 healthy controls without previous CHD history were recruited from individuals who visited investigator's hospital for physical examination during the same time period as the case enrollment.

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

A total of 200 eligible CHD patients were anticipated to include in this study.Moreover, The 200 healthy controls without previous CHD history were also recruited from individuals who visited investigator's hospital for physical examination during the same time period.

You may qualify if:

  • History of documented myocardial infarction;
  • Prior coronary revascularization intervention (coronary artery bypass graft surgery or percutaneous coronary intervention);
  • The presence of ≥ 50% stenosis in one or more coronary arteries identified during cardiac catheterization;

You may not qualify if:

  • History of malignancy or end-stage renal disease;
  • Blood transfusion within one month or prior bone marrow transplantation
  • Patients who reluctant to sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

Related Publications (1)

  • Liu LP, Cheng K, Ning MA, Li HH, Wang HC, Li F, Chen SY, Qu FL, Guo WY. Association between peripheral blood cells mitochondrial DNA content and severity of coronary heart disease. Atherosclerosis. 2017 Jun;261:105-110. doi: 10.1016/j.atherosclerosis.2017.02.013. Epub 2017 Feb 20.

    PMID: 28242046DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Mitochondria are responsible for multiple cellular functions including regulation of energy production, modulation of oxidation-reduction status, generation of reactive oxygen species and apoptosis. Each mitochondrion possesses multiple copies of a mitochondrial genome comprised of independently replicating double stranded DNA (mtDNA).

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • WenYi Guo, Professor

    Xijing Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director of Department of Cardiovascular Medicine

Study Record Dates

First Submitted

July 15, 2015

First Posted

July 17, 2015

Study Start

April 1, 2015

Primary Completion

August 1, 2015

Study Completion

November 1, 2015

Last Updated

May 17, 2016

Record last verified: 2016-05

Locations

CN(1)