Myocardial InfarctionNCT04127591
Differential Expression and Analysis of Peripheral Plasma Exosome miRNA in Patients With Myocardial Infarction
An observational study of Myocardial Infarction, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The aim of this study is to determine the miRNA expression profile in peripheral blood exosomes of patients with myocardial infarction and to investigate its relationship with myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- exosome
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2019to 30 Dec 2021
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients of myocardial infarction
Who may be able to join
- Age > 18 years ST elevation by ECG diagnostic of STEMI Evidency of coronary occlusion in coronariography Signed informed consent
Who cannot join
- Patients who will undergo immediate PCI Pregnant and lactating women Patients with mental disorders Patients are using other experimental drugs; Refusal to provide informed.
Trial locations and contacts
1 site in 1 country.
China1 site
Ethics Committee of Xinhua Hospital
Shanghai, Shanghai Municipality, 200092
About this study
The aim of this study is to determine the miRNA expression profile in peripheral blood exosomes of patients with myocardial infarction and to investigate its relationship with myocardial infarction.
Read the detailed description
Collect exosomes in peripheral blood of patients with myocardial infarction, compare the expression of miRNA with healthy volunteers, find out the miRNAs with significant differences, and explore its relationship with the development of myocardial infarction.
- Conditions
- Myocardial Infarction
- Being tested
- exosome
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exosomeOther
Collect exosomes in peripheral blood of patients and extract miRNAs from them.
| Study group | Role | What they receive |
|---|---|---|
| myocardial infarction group | Patients admitted with the diagnosis of myocardial infarction. Receives: Other: exosome | |
| Blank control group | Patients admitted without the diagnosis of myocardial infarction. Receives: Other: exosome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of differential expression of miRNA by second-generation sequencing technology
Measured: Day 7
Secondary outcomes (1)
Diagnostic value of the differential microRNAs evaluate by qPCR in patients of myocardial infarction
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start20 Oct 2019 (estimated)
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bin He, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04127591
- Sponsor's protocol ID
- XH-19-010
- Status last verified
- Oct 2019
- First submitted
- 14 Oct 2019
- Last updated
- 15 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Expression and Analysis of Peripheral Plasma Exosome miRNA in Patients With Myocardial Infarction
- ClinicalTrials.gov ID
- NCT04127591
- Acronym / sponsor ID
- XH-19-010
- Conditions
- Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 20 Oct 2019 (estimated)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 15 Oct 2019 (actual)
- 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 aim of this study is to determine the miRNA expression profile in peripheral blood exosomes of patients with myocardial infarction and to investigate its relationship with myocardial infarction.
Detailed description
Collect exosomes in peripheral blood of patients with myocardial infarction, compare the expression of miRNA with healthy volunteers, find out the miRNAs with significant differences, and explore its relationship with the development of myocardial infarction.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| myocardial infarction group | – | Other: exosomePatients admitted with the diagnosis of myocardial infarction. |
| Blank control group | – | Other: exosomePatients admitted without the diagnosis of myocardial infarction. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of myocardial infarction
Key inclusion criteria (1 listed)
- Age > 18 years ST elevation by ECG diagnostic of STEMI Evidency of coronary occlusion in coronariography Signed informed consent
Key exclusion criteria (1 listed)
- Patients who will undergo immediate PCI Pregnant and lactating women Patients with mental disorders Patients are using other experimental drugs; Refusal to provide informed.
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 |
|---|---|---|
| exosomeCollect exosomes in peripheral blood of patients and extract miRNAs from them. | Other | Blank control group, myocardial infarction group |
Primary outcome
Determination of differential expression of miRNA by second-generation sequencing technology
Time frame: Day 7
1 secondary outcome
Diagnostic value of the differential microRNAs evaluate by qPCR in patients of myocardial infarction
Time frame: Day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Myocardial Infarction
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Enrolling by invitation
The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention
Coronary Atherosclerosis and Other Heart Disease, Cardiovascular Diseases
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Not yet recruitingObservational study
Elicit Drugs in Myocardial Infarction
Young Patients With Acute Myocardial Infarction
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.
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 Myocardial Infarction, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 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: status not confirmed, as of the sponsor's last update on 15 Oct 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bin He (021-25077828, hebinicu@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of differential expression of miRNA by second-generation sequencing technology (time frame: Day 7). 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 15 Oct 2019; AzTrials last refreshed its copy on 6 Nov 2026.