Ischemic Heart DiseaseNCT06077721
Milrinone on Right Ventricular Strain in Cardiac Surgery
An observational study of Ischemic Heart Disease and Valvular Heart Disease, run by Konkuk University Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to analyze the changes in right ventricular strain before and after milrinone administration in order to find out whether milrinone improves RV systolic performance in patients undergoing cardiac surgery. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Ischemic Heart Disease, Valvular Heart Disease
- What is being tested?
- Milrinone
- Type of treatment
- Injection or infusion
- How many people
- 41 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Nov 2023to 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, coronary heart disease
Who may be able to join
- patient agree and provide written informed consent.
- patient undergoing elective cardiac surgery
- preoperative LV EF>50% (TTE)
Who cannot join
- preoperative cardiac dysrhythmia
- preoperative IABP
- use of other inotropic agents
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Konkuk University Medical Center
Seoul, 143-729
Tae-Yop Kim, MD PhD
About this study
Official title: Effect of Milrinone on the Right Ventricular Strain in Cardiac Surgery
The purpose of this study is to analyze the changes in right ventricular strain before and after milrinone administration in order to find out whether milrinone improves RV systolic performance in patients undergoing cardiac surgery.
- Conditions
- Ischemic Heart Disease, Valvular Heart Disease
- Being tested
- Milrinone
- Keywords
- Milrinone, strain, systolic function
- Medical subject headings
- Myocardial Ischemia, Heart Valve Diseases, Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MilrinoneDrug
Also called Milrinone intravenous administration
giving intravenous milrinone: 50 mcg/kg loading dose by IV push over 10 minutes, then 0.375-0.75 mcg/kg/ min infusion
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Right ventricular strain
Measured: 15 min after milrinone administration
Secondary outcomes (2)
Left ventricular strain
Measured: 15 min after milrinone administration
Left ventricular ejection fraction
Measured: 15 min after milrinone administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start3 Nov 2023
- 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
- 41 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
- Investigators
- Soi Lee, Study director, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077721
- Sponsor's protocol ID
- KUH 2023-09-060
- Status last verified
- Jan 2024
- First submitted
- 5 Oct 2023
- Last updated
- 19 Jan 2024
- 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 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Milrinone on the Right Ventricular Strain in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06077721
- Acronym / sponsor ID
- KUH 2023-09-060
- Conditions
- Ischemic Heart Disease, Valvular Heart Disease
- Keywords
- Milrinone, strain, systolic function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- 3 Nov 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 11 Oct 2023 (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 right ventricular strain before and after milrinone administration in order to find out whether milrinone improves RV systolic performance in patients undergoing cardiac surgery.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- valvular heart disease, coronary heart disease
Key inclusion criteria (3 listed)
- patient agree and provide written informed consent.
- patient undergoing elective cardiac 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 |
|---|---|---|
| MilrinoneAlso: Milrinone intravenous administrationgiving intravenous milrinone: 50 mcg/kg loading dose by IV push over 10 minutes, then 0.375-0.75 mcg/kg/ min infusion | Drug | – |
Primary outcome
1. Right ventricular strain
Time frame: 15 min after milrinone administration
2 secondary outcomes
Left ventricular strain
Time frame: 15 min after milrinone administration
Left ventricular ejection fraction
Time frame: 15 min after milrinone administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- 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.
Soi Lee study director
Konkuk University Medical Center
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 Ischemic Heart Disease and Valvular Heart Disease, run by Konkuk University Medical Center at 1 site in South Korea.
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 19 Jan 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 South Korea. 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 Tae-Yop Kim, MD PhD (82-2-2030-5457, taeyop@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Right ventricular strain (time frame: 15 min 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 19 Jan 2024.