Coronary DiseaseNCT03213743
Expression Profiling of microRNA Following Administration of Dexmedetomidine
A study testing Dexmedetomidine Injection in people with Coronary Disease, run by First Affiliated Hospital of Kunming Medical University at 1 site in China.
Trial summary
The purpose of the study is to find out the differential expression profiling of microRNA before and after adiministration of dexmedetomidine in patients undergoing procedures, and then investigators will do some in vitro studies to validate the functions of the microRNA. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Disease
- What is being tested?
- Dexmedetomidine Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteChina
- Study dates
- 19 Jun 2017to 21 Jun 2017
- Phase
- Interventional
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patients without arrithmia will undergo procedure.
Who cannot join
- The patients have bradycardia (hear rate is less than 60 beats per minute) or conduction block.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Expression Profiling of microRNA Following Administration of Dexmedetomidine in Patients Undergoing Procedures
The purpose of the study is to find out the differential expression profiling of microRNA before and after adiministration of dexmedetomidine in patients undergoing procedures, and then investigators will do some in vitro studies to validate the functions of the microRNA.
Read the detailed description
Background and objective: The use of dexmedetomidine may have benefits on the clinical outcomes of cardiac surgery. MicroRNAs are non-coding RNA sequences that act as regulators of gene expression. Investigators conduct a study to determine the role of microRNAs in cardioprotection mediated by dexmedetomidine.
Methods: In this study 3 patients were selected. The blood sample were taken before administration of dexmedetomidine.Investigators infused loading dose of dexmedetomidine for 10 minutes and maintaining dese of dexmedetomidine for 20 minutes.Thirty minutes after the administration, another blood samples were taken and stored in the liquid nitrogen and both the samples were marked. Those sample were analyzed for differentially expressed microRNA with Exiqon miRNA Array.
- Conditions
- Coronary Disease
- Being tested
- Dexmedetomidine Injection
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine InjectionDrug
Also called Dex group
Investigators gave the patients loading dose of dexmedetomidine for 10 minutes and maintaining dose of dexmedetomidine for 20 minutes. Investigators took blood samples before and after the administration of dexmedetomidine.
| Study group | Role | What they receive |
|---|---|---|
| before dexmedetomidine | Other | We took blood samples before the administration of dexmedetomidine to determine exression level of microRNA in the subjects. Receives: Drug: Dexmedetomidine Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
microRNA differential expression
microRNA differential expression exerts cardioprotection effect on patients undergoing procedures.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start19 Jun 2017
- Primary completion21 Jun 2017
- Study completion21 Jun 2017
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Kunming Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinqiao Qian, First Affiliated Hospital of Kunming Medical University
- Investigators
- Jinqiao Qian, Ph.D, Principal investigator, First Affiliated Hospital of Kunming Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03213743
- Sponsor's protocol ID
- 1stKunmingMCQJQ
- Status last verified
- Jul 2017
- First submitted
- 7 Jul 2017
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression Profiling of microRNA Following Administration of Dexmedetomidine in Patients Undergoing Procedures
- ClinicalTrials.gov ID
- NCT03213743
- Acronym / sponsor ID
- 1stKunmingMCQJQ
- Conditions
- Coronary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Kunming Medical UniversityUniversity, hospital or other
- Study start
- 19 Jun 2017 (actual)
- Primary completion
- 21 Jun 2017 (actual)
- Study completion
- 21 Jun 2017 (actual)
- First posted
- 11 Jul 2017 (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 purpose of the study is to find out the differential expression profiling of microRNA before and after adiministration of dexmedetomidine in patients undergoing procedures, and then investigators will do some in vitro studies to validate the functions of the microRNA.
Detailed description
Background and objective: The use of dexmedetomidine may have benefits on the clinical outcomes of cardiac surgery. MicroRNAs are non-coding RNA sequences that act as regulators of gene expression. Investigators conduct a study to determine the role of microRNAs in cardioprotection mediated by dexmedetomidine.
Methods: In this study 3 patients were selected. The blood sample were taken before administration of dexmedetomidine.Investigators infused loading dose of dexmedetomidine for 10 minutes and maintaining dese of dexmedetomidine for 20 minutes.Thirty minutes after the administration, another blood samples were taken and stored in the liquid nitrogen and both the samples were marked. Those sample were analyzed for differentially expressed microRNA with Exiqon miRNA Array.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| before dexmedetomidine | Other | Drug: Dexmedetomidine InjectionWe took blood samples before the administration of dexmedetomidine to determine exression level of microRNA in the subjects. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The patients without arrithmia will undergo procedure.
Key exclusion criteria (1 listed)
- The patients have bradycardia (hear rate is less than 60 beats per minute) or conduction block.
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 |
|---|---|---|
| Dexmedetomidine InjectionAlso: Dex groupInvestigators gave the patients loading dose of dexmedetomidine for 10 minutes and maintaining dose of dexmedetomidine for 20 minutes. Investigators took blood samples before and after the administration of dexmedetomidine. | Drug | before dexmedetomidine |
Primary outcome
microRNA differential expression
Time frame: 30 minutes
microRNA differential expression exerts cardioprotection effect on patients undergoing procedures.
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 11 Jul 2017.
- Individual participant dataSharing planned: No
Related trials for Coronary Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
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.
Jinqiao Qian, Ph.D principal investigator
First Affiliated Hospital of Kunming Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine Injection in people with Coronary Disease, run by First Affiliated Hospital of Kunming Medical University 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 11 Jul 2017. 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?
microRNA differential expression (time frame: 30 minutes). 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 11 Jul 2017.