NCT03540511

Brief Summary

Elevated level of troponin is frequently observed among patients with renal dysfunction. Increase in troponin after cardiac surgery may predict postoperative outcome in cardiac surgery patients. However, the relationship between the increased troponin and outcome after cardiac surgery has not been fully elucidated in patients with renal dysfunction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 1, 2018

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 30, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

1.5 years

First QC Date

May 15, 2018

Last Update Submit

March 3, 2020

Conditions

Renal Dysfunction

Keywords

cardiac surgerytroponinmortality

Outcome Measures

Primary Outcomes (1)

  • mortality

    mortality after cardiac surgery

    through study completion, average 3 years

Interventions

postoperative troponinDIAGNOSTIC_TEST

assess postoperative troponin levels after cardiac surgery in patients with renal dysfunction

Eligibility Criteria

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

Adult patients with renal dysfunction who underwent cardiac surgery between 2004 and 2015 at Seoul National University Hospital

You may qualify if:

  • Patients with renal dysfunction who underwent cardiac surgery between 2004 and 2015 at Seoul National University Hospital

You may not qualify if:

  • Patients without laboratory information on glomerular filtration rate or troponin levels

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Youn Joung Cho, MD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical assistant professor

Study Record Dates

First Submitted

May 15, 2018

First Posted

May 30, 2018

Study Start

May 1, 2018

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

March 4, 2020

Record last verified: 2020-03

Locations

KR(1)