Heart InjuriesEarly Phase 1EODOPWCHDNCT03095469
Effects of Dexmedetomidine on Patients With Coronary Heart Disease After Percutaneous Coronary Intervention
A Early Phase 1 study testing Dexmedetomidine and 0.9%NaCl solution in people with Heart Injuries, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
Coronary heart disease has a high incidence and high death rate. Percutaneous coronary intervention (PCI) is an important method for the treatment of coronary heart disease (CHD). However, PCI may cause myocardial cell injury and myocardial infarction 4 Type(MI4a, Type 4 a myocardial infarction related to PCI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Injuries
- What is being tested?
- Dexmedetomidine and 0.9%NaCl solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2017to 31 Dec 2017
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the patients were coincided to CHD combined with depression and anxiety according to diagnostic standard of World Health Organization(WHO)who need receive selective PCI in the First Affiliated Hospital of Xi'an Jiaotong University;
- people aged over 18;
- patients who will undergo PCI with Hamilton Anxiety scale of 14 points or more.
Who cannot join
- severe comorbidity history;
- coronary stenosis less than 70%;
- severe cardiac dysfunction;
- central nervous system disease;
- troponin I levels have rised before entering the hospital;
- pregnant woman；
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- history of mental disorders;
- alcoholic and long-term use of sedatives and opioids history;
- drug allergy history.
Trial locations and contacts
1 site in 1 country.
China1 site
the 1st affiliated hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Dong Maijuan, MD, 0086-15991666714, dmjxiaomai@163.com
About this study
Official title: Effects of Dexmedetomidine on Patients With Coronary Heart Disease After Percutaneous Coronary Intervention:A Double-Blinded, Randomised Controlled Trial
Coronary heart disease has a high incidence and high death rate. Percutaneous coronary intervention (PCI) is an important method for the treatment of coronary heart disease (CHD). However, PCI may cause myocardial cell injury and myocardial infarction 4 Type(MI4a, Type 4 a myocardial infarction related to PCI). Dexmedetomidine(Dex) is the only anesthetic which has sedative and analgesic effects. Dex currently has been widely used in perioperative management of various surgical.This study intends to verify the effect of heart protection of Dex in perioperative.
Read the detailed description
Participants will be randomly assigned, in a 1:1 ratio, to receive Dexmedetomidine or control (0.9 %Sodium Chloride Solution,0.9%NaCl). The randomization sequence will be computer-generated, and randomization will be performed in blocks and will be stratified according to participating center. Dexmedetomidine and 0.9 % NaCl solution will be transfused when the operation began, ending 24 hours after the surgery. Troponin I level(but are not limited to these data) at pre-operation and 3h, 6h,12h, 24h, 48h after PCI will be recorded. At the same time, other dates will be recorded.The participation of each patient is scheduled for 12 months.
- Conditions
- Heart Injuries
- Being tested
- Dexmedetomidine, 0.9%NaCl solution
- Medical subject headings
- Heart Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Dexmedetomidine Injection
when the operation begin,dexmedetomidine will be pumped at 0.4μg/kg•h for 15 minutes ,then reduce the dose to 0.2μg/kg•h until 24h after PCI.
0.9%NaCl solutionDrug
Also called Other Name: normal saline
when the operation begin,0.9%NaCl solution will be pumped at 0.1ml/kg•h until 24h after PCI.
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | when the operation begin,dexmedetomidine will be pumped at 0.4μg/kg•h for 15 minutes ,then reduce the dose to 0.2μg/kg•h until 24 h after PCI. Receives: Drug: Dexmedetomidine |
| control group | Placebo comparator | 0.9%NaCl solution 0.1ml/kg•h when the operation begin and stopped until 24 h after PCI. Receives: Drug: 0.9%NaCl solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of myocardial infarction type 4a (MI4a)
serum troponin(TnI) values at 48h after PCI is an important indicator for diagnosis of acute myocardial injury myocardial damage when troponin I lever rise.
Measured: detect serum TnI level before and 3h、6h、12h、24h、48h after PCI
Secondary outcomes (3)
post-procedural cardiac function
Echocardiographic results can reflect cardiac function.Echocardiography index include left ventricular ejection fraction(LVEF),left ventricular end-diastolic diameter (LVEDD), left ventricular end-diastolic volume (LVEDV) and stroke volume (SV),doppler mitral flow E/A ratio(E/A).
Measured: once 3 months for 6 months after PCI
major adverse cardiac events(MACEs)
MACEs' incidence reflects the incidence of MI4a
Measured: once 3 months for 12 months after PCI
systemic inflammatory markers
systemic inflammatory markers can reflect the situation of cardiac injures,like tumor necrosis factor alpha(TNF-α),interleukin-6(IL-6),interleukin-8(IL-8),high-sensitivity C-reactive protein(hs-CRP).
Measured: before and 1 week after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start20 Aug 2017 (estimated)
- Primary completion30 Nov 2017 (estimated)
- Study completion31 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart InjuriesStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- coronary artery disease patients with anxiety who receive selective PCI
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qiang Wang, PHD, Study chair, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03095469
- Sponsor's protocol ID
- XJTU1AF-CRF-2016T-09
- Acronym
- EODOPWCHD
- Status last verified
- Jun 2017
- First submitted
- 26 Feb 2017
- Last updated
- 9 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- 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 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dexmedetomidine on Patients With Coronary Heart Disease After Percutaneous Coronary Intervention:A Double-Blinded, Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03095469
- Acronym / sponsor ID
- EODOPWCHD / XJTU1AF-CRF-2016T-09
- Conditions
- Heart Injuries
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 20 Aug 2017 (estimated)
- Primary completion
- 30 Nov 2017 (estimated)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 29 Mar 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.
Coronary heart disease has a high incidence and high death rate. Percutaneous coronary intervention (PCI) is an important method for the treatment of coronary heart disease (CHD). However, PCI may cause myocardial cell injury and myocardial infarction 4 Type(MI4a, Type 4 a myocardial infarction related to PCI). Dexmedetomidine(Dex) is the only anesthetic which has sedative and analgesic effects. Dex currently has been widely used in perioperative management of various surgical.This study intends to verify the effect of heart protection of Dex in perioperative.
Detailed description
Participants will be randomly assigned, in a 1:1 ratio, to receive Dexmedetomidine or control (0.9 %Sodium Chloride Solution,0.9%NaCl). The randomization sequence will be computer-generated, and randomization will be performed in blocks and will be stratified according to participating center. Dexmedetomidine and 0.9 % NaCl solution will be transfused when the operation began, ending 24 hours after the surgery. Troponin I level(but are not limited to these data) at pre-operation and 3h, 6h,12h, 24h, 48h after PCI will be recorded. At the same time, other dates will be recorded.The participation of each patient is scheduled for 12 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- coronary artery disease patients with anxiety who receive selective PCI
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Drug: Dexmedetomidinewhen the operation begin,dexmedetomidine will be pumped at 0.4μg/kg•h for 15 minutes ,then reduce the dose to 0.2μg/kg•h until 24 h after PCI. |
| control group | Placebo comparator | Drug: 0.9%NaCl solution0.9%NaCl solution 0.1ml/kg•h when the operation begin and stopped until 24 h after PCI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- the patients were coincided to CHD combined with depression and anxiety according to diagnostic standard of World Health Organization(WHO)who need receive selective PCI in the First Affiliated Hospital of Xi'an Jiaotong University;
- people aged over 18;
- patients who will undergo PCI with Hamilton Anxiety scale of 14 points or more.
Key exclusion criteria (9 listed)
- severe comorbidity history;
- coronary stenosis less than 70%;
- severe cardiac dysfunction;
- central nervous system disease;
- troponin I levels have rised before entering the hospital;
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 |
|---|---|---|
| DexmedetomidineAlso: Dexmedetomidine Injectionwhen the operation begin,dexmedetomidine will be pumped at 0.4μg/kg•h for 15 minutes ,then reduce the dose to 0.2μg/kg•h until 24h after PCI. | Drug | study group |
| 0.9%NaCl solutionAlso: Other Name: normal salinewhen the operation begin,0.9%NaCl solution will be pumped at 0.1ml/kg•h until 24h after PCI. | Drug | control group |
Primary outcome
the incidence of myocardial infarction type 4a (MI4a)
Time frame: detect serum TnI level before and 3h、6h、12h、24h、48h after PCI
serum troponin(TnI) values at 48h after PCI is an important indicator for diagnosis of acute myocardial injury myocardial damage when troponin I lever rise.
3 secondary outcomes
post-procedural cardiac function
Time frame: once 3 months for 6 months after PCI
major adverse cardiac events(MACEs)
Time frame: once 3 months for 12 months after PCI
systemic inflammatory markers
Time frame: before and 1 week after PCI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2017.
- Individual participant dataSharing planned: Undecided
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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.
Qiang Wang, PHD study chair
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Dexmedetomidine and 0.9%NaCl solution in people with Heart Injuries, run by First Affiliated Hospital Xi'an Jiaotong 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 3 inclusion and 9 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 9 Jun 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Maijuan Dong, MD (0086-15991666714, dmjxiaomai@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of myocardial infarction type 4a (MI4a) (time frame: detect serum TnI level before and 3h、6h、12h、24h、48h after PCI). 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 9 Jun 2017.