NCT04153383

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2019

Completed
4.8 years until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

3 months

First QC Date

November 4, 2019

Last Update Submit

September 26, 2023

Conditions

Ischemic Heart Disease

Keywords

Milrinonediastolic function

Outcome Measures

Primary Outcomes (1)

  • TMAD of ticuspid annulus during early relaxation

    15 mini after milrinone administration

Secondary Outcomes (3)

  • global longitudinal strain of the right ventricle

    15 mini after milrinone administration

  • left ventricular ejection fraction

    15 min after milline administration

  • global longitudinal strain of the left ventricle

    15 min after milline administration

Study Arms (1)

TMAD

Tissue motion annular displacement (TMAD) of tricuspid valve annulus transesophageal echocardiography

Drug: Milrinone Injection

Interventions

Milrinone InjectionDRUG

giving IV milrinone: 50 mcg/kg loading dose by IV push over 10 minutes, then 0.375-0.75 mcg/kg/min IV

Also known as: Milrinone
TMAD

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

valvular heart disease

You may qualify if:

  • patient agree and provide written informed consent.
  • patient undergoing elective coronary artery bypass graft surgery
  • preoperative LV EF\>50% (TTE)

You may not qualify if:

  • preoperative cardiac dysrhythmia
  • preoperative IABP
  • use of other inotropic agents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Milrinone

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

AmrinoneAminopyridinesAminesOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology

Study Record Dates

First Submitted

November 4, 2019

First Posted

November 6, 2019

Study Start

September 1, 2024

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

September 28, 2023

Record last verified: 2023-09