- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04153383
Milrinone on Cardiac Performance During Off-pump Coronary Artery Bypass Surgery
September 26, 2023 updated by: Tae-Yop Kim, MD PhD, Konkuk University Medical Center
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
20
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
valvular heart disease
Description
Inclusion Criteria:
- patient agree and provide written informed consent.
- patient undergoing elective coronary artery bypass graft surgery
- preoperative LV EF>50% (TTE)
Exclusion Criteria:
- preoperative cardiac dysrhythmia
- preoperative IABP
- use of other inotropic agents
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
TMAD
Tissue motion annular displacement (TMAD) of tricuspid valve annulus transesophageal echocardiography
|
giving IV milrinone: 50 mcg/kg loading dose by IV push over 10 minutes, then 0.375-0.75
mcg/kg/min IV
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
TMAD of ticuspid annulus during early relaxation
Time Frame: 15 mini after milrinone administration
|
15 mini after milrinone administration
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
global longitudinal strain of the right ventricle
Time Frame: 15 mini after milrinone administration
|
15 mini after milrinone administration
|
|
left ventricular ejection fraction
Time Frame: 15 min after milline administration
|
15 min after milline administration
|
|
global longitudinal strain of the left ventricle
Time Frame: 15 min after milline administration
|
15 min after milline administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 1, 2024
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
November 4, 2019
First Submitted That Met QC Criteria
November 4, 2019
First Posted (Actual)
November 6, 2019
Study Record Updates
Last Update Posted (Actual)
September 28, 2023
Last Update Submitted That Met QC Criteria
September 26, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Heart Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Enzyme Inhibitors
- Platelet Aggregation Inhibitors
- Protective Agents
- Cardiotonic Agents
- Phosphodiesterase Inhibitors
- Phosphodiesterase 3 Inhibitors
- Milrinone
Other Study ID Numbers
- KUH0000000123
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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