Association Between Mitochondrial DNA Content and Risk of Coronary Heart Disease

Coronary Heart Disease Clinical Trial

Official title:

Association Between Mitochondrial DNA Copy Number in Peripheral Blood Cells and Risk of Developing Coronary Heart Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02500823
• Other study ID #: KY20140813-2
• Status: Recruiting
• Phase: N/A
• First received: July 15, 2015
• Last updated: July 16, 2015
• Start date: April 2015
• Est. completion date: December 2015

Study information

• Verified date: July 2015
• Source: Fourth Military Medical University
• Contact: LiPeng Liu, Doctor
• Phone: +8629-84771170
• Email: lipeng88859[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. History of documented myocardial infarction;

2. Prior coronary revascularization intervention (coronary artery bypass graft surgery or percutaneous coronary intervention);

3. The presence of = 50% stenosis in one or more coronary arteries identified during cardiac catheterization;

Exclusion Criteria:

1. History of malignancy or end-stage renal disease;

2. Blood transfusion within one month or prior bone marrow transplantation

3. Patients who reluctant to sign informed consent

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No