Coronary DiseaseNCT02751060
Evaluation of Plasma Non-coding RNAs as Biomarkers in Coronary Heart Disease
An observational study of Coronary Disease, run by Tongji Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine whether the expression level of miR-320a are effective as biomarker in evaluating the diagnosis, prognosis and treatment effects of coronary heart disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease
- How many people
- 4,000 participants
- Where
- 1 siteChina
- Study dates
- Apr 2016to Dec 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 4000 outpatients or hospitalized patients with coronary heart diseasewill be enrolled in this study.
Who may be able to join
- 18 years of age or older;
- the most recent symptoms of coronary heart disease within 7 days;
- meet one of the following conditions: A. clinical history of typical ischemic chest pain (more than 5 minutes of persistent chest pain); B. serum cardiac biomarkers positive (TnT/I or creatine kinase peak greater than 99% of URL); C. Electrocardiogram changes of myocardial ischemia.
Who cannot join
- pregnant women or plan to;
- participate in any drug clinical trials within 3 months;
- patients with life-threatening complications, or the researchers determined that the survival time of patients with no more than 1 years;
- serious neurological disease (Alzheimer's disease, Parkinson syndrome, progressive lower limbs or deaf patients);
- previous history of cancer or tumor, or pathological examination confirmed precancerous lesions (such as breast ductal carcinoma in situ, or atypical hyperplasia of the cervix);
- patients refused to comply with the requirements of this study to complete the research work;
- according to the researchers, patients can not complete the study or not to comply with the requirements of this study (because of the reasons for the management or other reasons).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Plasma Non-coding RNAs (miRNA-320a) as Biomarkers of Diagnosis, Prognosis and Treatment Effects in Coronary Heart Disease
The purpose of this study is to determine whether the expression level of miR-320a are effective as biomarker in evaluating the diagnosis, prognosis and treatment effects of coronary heart disease.
- Conditions
- Coronary Disease
- Being tested
- No intervention
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| patients with coronary heart disease symptoms | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
the plasma expression of miR-320a in coronary heart disease patients compared to control patients
Measured: up to 24 months
Secondary outcomes (5)
number of participants with cardiovascular causes of death
Measured: up to 24 months
number of participants with non fatal myocardial infarction or stroke
Measured: up to 24 months
number of participants with re-hospitalization due to cardiovascular causes
Measured: up to 24 months
number of participants with all causes of mortality
Measured: up to 24 months
number of participants with myocardial infarction re-exacerbation or re-hospitalization
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dao Wen Wang, Tongji Hospital
- Investigators
- Dao Wen Wang, Doctor, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02751060
- Sponsor's protocol ID
- TJ-IRB20160305
- Status last verified
- Apr 2024
- First submitted
- 20 Apr 2016
- Last updated
- 10 Apr 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Plasma Non-coding RNAs (miRNA-320a) as Biomarkers of Diagnosis, Prognosis and Treatment Effects in Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT02751060
- Acronym / sponsor ID
- TJ-IRB20160305
- Conditions
- Coronary Disease
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Apr 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.
The purpose of this study is to determine whether the expression level of miR-320a are effective as biomarker in evaluating the diagnosis, prognosis and treatment effects of coronary heart disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with coronary heart disease symptoms | – | Other: No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 4000 outpatients or hospitalized patients with coronary heart diseasewill be enrolled in this study.
Key inclusion criteria (3 listed)
- 18 years of age or older;
- the most recent symptoms of coronary heart disease within 7 days;
- meet one of the following conditions: A. clinical history of typical ischemic chest pain (more than 5 minutes of persistent chest pain); B. serum cardiac biomarkers positive (TnT/I or creatine kinase peak greater than 99% of URL); C. Electrocardiogram changes of myocardial ischemia.
Key exclusion criteria (7 listed)
- pregnant women or plan to;
- participate in any drug clinical trials within 3 months;
- patients with life-threatening complications, or the researchers determined that the survival time of patients with no more than 1 years;
- serious neurological disease (Alzheimer's disease, Parkinson syndrome, progressive lower limbs or deaf patients);
- previous history of cancer or tumor, or pathological examination confirmed precancerous lesions (such as breast ductal carcinoma in situ, or atypical hyperplasia of the cervix);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention | Other | patients with coronary heart disease symptoms |
Primary outcome
the plasma expression of miR-320a in coronary heart disease patients compared to control patients
Time frame: up to 24 months
5 secondary outcomes
number of participants with cardiovascular causes of death
Time frame: up to 24 months
number of participants with non fatal myocardial infarction or stroke
Time frame: up to 24 months
number of participants with re-hospitalization due to cardiovascular causes
Time frame: up to 24 months
number of participants with all causes of mortality
Time frame: up to 24 months
number of participants with myocardial infarction re-exacerbation or re-hospitalization
Time frame: up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
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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.
Dao Wen Wang, Doctor principal investigator
Tongji 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 Disease, run by Tongji Hospital 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 7 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: enrolling by invitation, as of the sponsor's last update on 10 Apr 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
the plasma expression of miR-320a in coronary heart disease patients compared to control patients (time frame: up to 24 months). 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 10 Apr 2024.