Coronary Heart DiseaseNCT02500823
Association Between Mitochondrial DNA Content and Risk of Coronary Heart Disease
An observational study of Coronary Heart Disease, run by Air Force Military Medical University, China at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Heart Disease
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- Apr 2015to Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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;
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Mitochondrial DNA Copy Number in Peripheral Blood Cells and Risk of Developing Coronary Heart Disease
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.
- Conditions
- Coronary Heart Disease
- Keywords
- Mitochondrial DNA copy number, Peripheral blood cells
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From date of percutaneous coronary intervention until the date of discharging from hospital, assessed up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study startApr 2015
- Primary completionAug 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenyi Guo, Air Force Military Medical University, China
- Investigators
- WenYi Guo, Professor, Principal investigator, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02500823
- Sponsor's protocol ID
- KY20140813-2
- Status last verified
- May 2016
- First submitted
- 15 Jul 2015
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28242046
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Mitochondrial DNA Copy Number in Peripheral Blood Cells and Risk of Developing Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT02500823
- Acronym / sponsor ID
- KY20140813-2
- Conditions
- Coronary Heart Disease
- Keywords
- Mitochondrial DNA copy number, Peripheral blood cells
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 17 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Relative copy number of mitochondrial DNA
Time frame: From date of percutaneous coronary intervention until the date of discharging from hospital, assessed up to 5 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2016.
- Derived from this study: PubMed 28242046Liu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
WenYi Guo, Professor principal investigator
Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease, run by Air Force Military Medical University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative copy number of mitochondrial DNA (time frame: From date of percutaneous coronary intervention until the date of discharging from hospital, assessed up to 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02500823, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2016.