Milrinone on Cardiac Performance During Off-pump Coronary... | NCT04153383

Studies
Milrinone on Cardiac Performance During Off-pump Coronary Artery Bypass Surgery

NCT04153383

Sponsor

Konkuk University Medical Center

Status

Unknown status

Last Update Posted

Sep 28, 2023Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Ischemic Heart Disease

Interventions

Milrinone Injection

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2024Estimated

Primary Completion Date

Dec 2024Estimated

Completion Date

Dec 2024Estimated

First Submitted Date

Nov 4, 2019

First Submission Date that Met QC Criteria

Nov 4, 2019

First Posted Date

Nov 6, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 26, 2023

Last Update Posted Date

Sep 28, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tae-Yop Kim, MD PhD, Professor of Anesthesiology, Konkuk University Medical CenterPrincipal Investigator

Lead Sponsor

Konkuk University Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TMAD		Tissue motion annular displacement (TMAD) of tricuspid valve annulus transesophageal echocardiography	Drug: Milrinone Injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Milrinone Injection	Drug	giving IV milrinone: 50 mcg/kg loading dose by IV push over 10 minutes, then 0.375-0.75 mcg/kg/min IV	TMAD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
TMAD of ticuspid annulus during early relaxation		15 mini after milrinone administration

Secondary Outcomes

Measure	Description	Time Frame
global longitudinal strain of the right ventricle		15 mini after milrinone administration
left ventricular ejection fraction		15 min after milline administration

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

valvular heart disease

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D017202	Myocardial Ischemia

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020105	Milrinone

Ancestor Terms

ID	Term
D000676	Amrinone
D000631	Aminopyridines
D000588	Amines
D009930	Organic Chemicals
D011725

Browse Leaves

Not provided

Browse Branches

Not provided