NCT02394405

Brief Summary

Assessment of the severity of oxidative stress caused by the on-pump and off-pump cardiac surgery using mtDNA, nDNA, carbonilated proteins, nitrotyrosine, oxy-LDL, S100b-protein.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

February 12, 2015

Completed
17 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 20, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

August 15, 2019

Status Verified

August 1, 2019

Enrollment Period

3 years

First QC Date

February 12, 2015

Last Update Submit

August 13, 2019

Conditions

Reperfusion Injury

Outcome Measures

Primary Outcomes (1)

  • Assay of mtDNA

    from baseline whithin 72 hours

Secondary Outcomes (5)

  • Assay of nDNA

    from baseline whithin 72 hours

  • Assay of carbonilated proteins

    from baseline whithin 72 hours

  • Assay of nitrotyrosine

    from baseline whithin 72 hours

  • Assay of oxy-LDL

    from baseline whithin 72 hours

  • Assay of S100b-protein

    from baseline whithin 72 hours

Study Arms (3)

valve surgery

valve plasty/replacement surgery

off-pump CABG

off-pump CABG

CPB-CABG

CABG with CardioPulmonal Bypass

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

primary care clinic

You may qualify if:

  • shedduled CABG

You may not qualify if:

  • stroke befor surgery
  • miocardial infarction 6 monthes befor surgery
  • dementia
  • liver cirrhosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy

Moscow, 129110, Russia

Location

MeSH Terms

Conditions

Reperfusion Injury

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
senior researcher

Study Record Dates

First Submitted

February 12, 2015

First Posted

March 20, 2015

Study Start

March 1, 2015

Primary Completion

March 1, 2018

Study Completion

December 1, 2018

Last Updated

August 15, 2019

Record last verified: 2019-08

Locations

RU(1)