Ischemic Heart DiseaseNCT04153383
Milrinone on Cardiac Performance During Off-pump Coronary Artery Bypass Surgery
An observational study of Ischemic Heart Disease, run by Konkuk University Medical Center.
Trial summary
The purpose of this study is to analyze the changes in cardiac performance before and after milrinone administration in order to find out whether milrinone improves LV performance in patients undergoing coronary artery bypass surgery. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- Milrinone Injection
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Dec 2024
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: valvular heart disease
Who may be able to join
- patient agree and provide written informed consent.
- patient undergoing elective coronary artery bypass graft surgery
- preoperative LV EF>50% (TTE)
Who cannot join
- preoperative cardiac dysrhythmia
- preoperative IABP
- use of other inotropic agents
About this study
Official title: Milrinone on Cardiac Performance in Patients Undergoing Off-pump Coronary Artery Bypass Surgery
The purpose of this study is to analyze the changes in cardiac performance before and after milrinone administration in order to find out whether milrinone improves LV performance in patients undergoing coronary artery bypass surgery.
- Conditions
- Ischemic Heart Disease
- Being tested
- Milrinone Injection
- Keywords
- Milrinone, diastolic function
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milrinone InjectionDrug
Also called Milrinone
giving IV milrinone: 50 mcg/kg loading dose by IV push over 10 minutes, then 0.375-0.75 mcg/kg/min IV
| Study group | Role | What they receive |
|---|---|---|
| TMAD | Tissue motion annular displacement (TMAD) of tricuspid valve annulus transesophageal echocardiography Receives: Drug: Milrinone Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
TMAD of ticuspid annulus during early relaxation
Measured: 15 mini after milrinone administration
Secondary outcomes (3)
global longitudinal strain of the right ventricle
Measured: 15 mini after milrinone administration
left ventricular ejection fraction
Measured: 15 min after milline administration
global longitudinal strain of the left ventricle
Measured: 15 min after milline administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study startSep 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tae-Yop Kim, MD PhD, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04153383
- Sponsor's protocol ID
- KUH0000000123
- Status last verified
- Sep 2023
- First submitted
- 4 Nov 2019
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Milrinone on Cardiac Performance in Patients Undergoing Off-pump Coronary Artery Bypass Surgery
- ClinicalTrials.gov ID
- NCT04153383
- Acronym / sponsor ID
- KUH0000000123
- Conditions
- Ischemic Heart Disease
- Keywords
- Milrinone, diastolic function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 6 Nov 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 purpose of this study is to analyze the changes in cardiac performance before and after milrinone administration in order to find out whether milrinone improves LV performance in patients undergoing coronary artery bypass surgery.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TMAD | – | Drug: Milrinone InjectionTissue motion annular displacement (TMAD) of tricuspid valve annulus transesophageal echocardiography |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- valvular heart disease
Key inclusion criteria (3 listed)
- patient agree and provide written informed consent.
- patient undergoing elective coronary artery bypass graft surgery
- preoperative LV EF>50% (TTE)
Key exclusion criteria (3 listed)
- preoperative cardiac dysrhythmia
- preoperative IABP
- use of other inotropic agents
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 |
|---|---|---|
| Milrinone InjectionAlso: Milrinonegiving IV milrinone: 50 mcg/kg loading dose by IV push over 10 minutes, then 0.375-0.75 mcg/kg/min IV | Drug | TMAD |
Primary outcome
TMAD of ticuspid annulus during early relaxation
Time frame: 15 mini after milrinone administration
3 secondary outcomes
global longitudinal strain of the right ventricle
Time frame: 15 mini after milrinone administration
left ventricular ejection fraction
Time frame: 15 min after milline administration
global longitudinal strain of the left ventricle
Time frame: 15 min after milline administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Heart Disease, run by Konkuk University Medical Center.
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 3 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 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
TMAD of ticuspid annulus during early relaxation (time frame: 15 mini after milrinone administration). 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 28 Sep 2023.