Analysis of miRNAs Expression in Vasoplegic Syndrome After On-pump Coronary Artery Bypass Surgery (PREVENT)

Analysis of microRNAs Expression in Patients Who Evolved to Vasoplegic Syndrome After On-pump Coronary Artery Bypass Surgery

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

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Surgery; Vasoplegia; Cardiovascular Morbidity; Surgery-Complications; Vasoplegic Syndrome
• Intervention / Treatment: Other: vasoplegic syndrome

Detailed Description

Cardiovascular diseases (CVD) are among the main causes of morbidity and mortality in the world, and in Brazil they account for approximately 31% of all causes of death and 42% of deaths due to noncommunicable diseases. In 2014 were carried out a total number of 92,000 heart surgeries in Brazil and these are usually performed using Cardiopulmonary Bypass (CPB), which is made by the diversion of blood circulation of the lungs and heart to a heart-lung machine, which keeps cardio circulatory functions and oxygenates the blood. Despite enable various types of major cardiac surgery, the use of CPB can cause serious side effects such as post perfusion vasoplegic syndrome (VS). This is characterized by increased cardiac output, hypotension, systemic inflammatory response and decreased vascular resistance, affecting 9-44% of patients in the postoperative period of cardiac surgery, with a mortality of 27%. Treatment to VS are limited and the drugs are often ineffective, including noradrenaline, vasopressin, and methylene blue. Another difficulty encountered by the surgeon is to establish a predictive factor for VS. Systems risk predictors that use score and are well validated as EuroSCORE (European System for Cardiac Operative Risk Evaluation) have not been tested for VS. Much has been studied on the use of biomarkers as predictors and for prognosis as well as to improve predictive power of the rating systems available. MicroRNAs (miRNAs) are noncoding RNA molecules that control gene expression in the intracellular environment and are present circulating in various body fluids including peripheral blood. These molecules can be used as biomarkers of various pathologies including CVD. Despite the existence of numerous studies that demonstrate the importance of miRNAs in the development of CVDs. There are no studies that address the issue in VS. Therefore, the objective of the project is to identify the presence of blood miRNAs that are altered in patients with pre and intra-operative cardiovascular surgery and assess whether these miRNAs can be used as predictors and biomarkers of mortality for VS.

• Study Type: Observational
• Enrollment (Actual): 320

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05409011
    • Omar Asdrubal Vilca Mejia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
vasoplegic syndrome; Patients undergoing on-pump coronary artery bypass graft who develops vasoplegic syndrome 24 - 48 hours after surgery.	Other: vasoplegic syndrome; 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
control; Patients undergoing on-pump coronary artery bypass graft who does not develop vasoplegic syndrome.	Other: vasoplegic syndrome; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Profile of miRNA	Find out if it is possible to use mirna as a predictor of vasoplegic syndrome	6 months

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo; InCor Heart Institute
• Investigators: Principal Investigator: Omar Mejía, InCor Heart Institute; Principal Investigator: Renato Cesar de Souza, InCor Heart Institute; Principal Investigator: Edecio Cunha-Neto, InCor Heart Institute; Study Chair: Fábio Jatene, InCor Heart Institute; Principal Investigator: Ludmila Ferreira, Federal University of Minas Gerais; Principal Investigator: Bianca Meneguini, InCor Heart Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2017
• Primary Completion (Actual): December 28, 2019
• Study Completion (Actual): December 28, 2019

Study Registration Dates

• First Submitted: January 10, 2018
• First Submitted That Met QC Criteria: April 25, 2022
• First Posted (Actual): April 29, 2022

Study Record Updates

• Last Update Posted (Actual): May 10, 2022
• Last Update Submitted That Met QC Criteria: May 4, 2022
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: microRNAs; surgery; cardiovascular; miRNAs; vasoplegic syndrome; vasoplegic
• Additional Relevant MeSH Terms: Pathologic Processes; Vascular Diseases; Postoperative Complications; Disease; Cardiovascular Diseases; Syndrome; Vasoplegia
• Other Study ID Numbers: 4435/16/101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No