Acute Coronary SyndromeNCT02775279
Association Between Telomere Length and Risk of Acute Coronary Syndrome
An observational study of Acute Coronary Syndrome, run by Air Force Military Medical University, China at 1 site in China.
Trial summary
Compelling epidemiological evidence indicates that alterations length of telomere, are associated with the initiation and development of ischemic heart disease. This study was undertaken to investigate whether mtDNA copy number in peripheral blood leukocyte could be used as a risk predictor for acute coronary syndrome. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to May 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 200 eligible ACS 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
- -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;
Who cannot join
- -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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short Telomere Length in Peripheral Blood Leukocyte Predicts the Risk of Acute Coronary Syndrome
Compelling epidemiological evidence indicates that alterations length of telomere, are associated with the initiation and development of ischemic heart disease. This study was undertaken to investigate whether mtDNA copy number in peripheral blood leukocyte could be used as a risk predictor for acute coronary syndrome.
- Conditions
- Acute Coronary Syndrome
- Keywords
- acute coronary syndrome, telomere length, predictive factor
- Medical subject headings
- Acute Coronary Syndrome
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 |
|---|---|---|
| Acute coronary syndrome group | 200 consecutive patients were recruited, who have diagnosed with acute coronary syndrom(ACS) by quantitative 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 telomere length
the ratio of telomere repeat copy number(T) to the hemoglobin(HGB) copy number (S) was determined for each sample using standard curves. The derived T/S ratio was proportional to the relative telomere length(RTL). In the second step, the T/S ratio of each sample was normalized to a calibrator DNA to standardize between different PCR runs. The calibrated T/S ratio was then used as the measurement of RTL in this study.
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 May 2016 (estimated)
- Study startJan 2016
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies 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
- Cross-sectional
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02775279
- Sponsor's protocol ID
- XJ20160520
- Status last verified
- May 2016
- First submitted
- 14 May 2016
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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
- Short Telomere Length in Peripheral Blood Leukocyte Predicts the Risk of Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT02775279
- Acronym / sponsor ID
- XJ20160520
- Conditions
- Acute Coronary Syndrome
- Keywords
- acute coronary syndrome, telomere length, predictive factor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 17 May 2016 (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 length of telomere, are associated with the initiation and development of ischemic heart disease. This study was undertaken to investigate whether mtDNA copy number in peripheral blood leukocyte could be used as a risk predictor for acute coronary syndrome.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute coronary syndrome group | – | –200 consecutive patients were recruited, who have diagnosed with acute coronary syndrom(ACS) by quantitative 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
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 200 eligible ACS 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 (1 listed)
- -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;
Key exclusion criteria (1 listed)
- -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
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 telomere length
Time frame: From date of percutaneous coronary intervention until the date of discharging from hospital, assessed up to 5 days
the ratio of telomere repeat copy number(T) to the hemoglobin(HGB) copy number (S) was determined for each sample using standard curves. The derived T/S ratio was proportional to the relative telomere length(RTL). In the second step, the T/S ratio of each sample was normalized to a calibrator DNA to standardize between different PCR runs. The calibrated T/S ratio was then used as the measurement of RTL in this study.
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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Acute Coronary Syndrome, 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 1 inclusion and 1 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 telomere length (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?
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.