NCT05354193

Brief Summary

This study looks for a correlation between microRNAs (miRNAs) and vasoplegic syndrome after on-pump coronary artery bypass surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
320

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2017

Typical duration for all trials

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

August 28, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2019

Completed
2.3 years until next milestone

First Posted

Study publicly available on registry

April 29, 2022

Completed
Last Updated

May 10, 2022

Status Verified

January 1, 2018

Enrollment Period

2.3 years

First QC Date

January 10, 2018

Last Update Submit

May 4, 2022

Conditions

Vasoplegic SyndromeVasoplegiaSurgery-ComplicationsSurgeryCardiovascular DiseasesCardiovascular Morbidity

Keywords

vasoplegic syndromevasoplegicsurgerycardiovascularmicroRNAsmiRNAs

Outcome Measures

Primary Outcomes (1)

  • Profile of miRNA

    Find out if it is possible to use mirna as a predictor of vasoplegic syndrome

    6 months

Study Arms (2)

vasoplegic syndrome

Patients undergoing on-pump coronary artery bypass graft who develops vasoplegic syndrome 24 - 48 hours after surgery.

Other: vasoplegic syndrome

control

Patients undergoing on-pump coronary artery bypass graft who does not develop vasoplegic syndrome.

Other: vasoplegic syndrome

Interventions

vasoplegic syndromeOTHER

In all included patients, 3 milliliters of venous blood will be collected before cardiopulmonary bypass, 3 milliliters of venous blood 15 minutes after the reversal of heparin with protamine and a small fragment of aortic tissue. Samples of biological material will be compared between the control and vasoplegic groups for the difference in amount and type of miRNA present. For the diagnosis of vasospastic syndrome, the following criteria were adopted: mean arterial pressure \< 65 mmHg, cardiac index \< 2.2 L / min / m2, refractory to replacement of at least 1000 milliliters of crystalloid, excluding other causes such as tamponade, bleeding and cardiogenic shock

controlvasoplegic syndrome

Eligibility Criteria

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

Our population is build whith both sexy, bigger than 18 years old, who has indication of coronary artery surgery. that was selected.

You may qualify if:

  • Patients who go to coronary artery by-pass , on-pump surgery
  • Patients who sign an informed consent
  • Only elective or urgency surgery

You may not qualify if:

  • off-pump surgery
  • emergency surgery
  • previous use of vasoactive drugs or Intra aortic balloon
  • Patients with active acute coronary syndrome
  • Acute mesenteric ischemia, Reynaud disease, neoplasia and Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Omar Asdrubal Vilca Mejia

São Paulo, 05409011, Brazil

Location

Biospecimen

Retention: SAMPLES WITH DNA

3 milliliters of venous blood will be collected before CPB, 3 milliliters of venous blood 15 minutes after the reversal of heparin with protamine and a small fragment of aortic tissue.

MeSH Terms

Conditions

VasoplegiaCardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Omar Mejía

    InCor Heart Institute

    PRINCIPAL INVESTIGATOR

  • Renato Cesar de Souza

    InCor Heart Institute

    PRINCIPAL INVESTIGATOR

  • Edecio Cunha-Neto

    InCor Heart Institute

    PRINCIPAL INVESTIGATOR

  • Fábio Jatene

    InCor Heart Institute

    STUDY CHAIR

  • Ludmila Ferreira

    Federal University of Minas Gerais

    PRINCIPAL INVESTIGATOR

  • Bianca Meneguini

    InCor Heart Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2018

First Posted

April 29, 2022

Study Start

August 28, 2017

Primary Completion

December 28, 2019

Study Completion

December 28, 2019

Last Updated

May 10, 2022

Record last verified: 2018-01

Locations

BR(1)