Vasoplegic SyndromePREVENTNCT05354193
Analysis of miRNAs Expression in Vasoplegic Syndrome After On-pump Coronary Artery Bypass Surgery
An observational study of Vasoplegic Syndrome and Vasoplegia, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
This study looks for a correlation between microRNAs (miRNAs) and vasoplegic syndrome after on-pump coronary artery bypass surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vasoplegic Syndrome, Vasoplegia, Surgery-Complications
- What is being tested?
- vasoplegic syndrome
- How many people
- 320 participants
- Where
- 1 siteBrazil
- Study dates
- 28 Aug 2017to 28 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Our population is build whith both sexy, bigger than 18 years old, who has indication of coronary artery surgery. that was selected.
Who may be able to join
- Patients who go to coronary artery by-pass , on-pump surgery
- Patients who sign an informed consent
- Only elective or urgency surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Vasoplegic Syndrome, Vasoplegia, Surgery-Complications, Surgery, Cardiovascular Diseases, Cardiovascular Morbidity
- Being tested
- vasoplegic syndrome
- Keywords
- vasoplegic syndrome, vasoplegic, surgery, cardiovascular, microRNAs, miRNAs
- Medical subject headings
- Vasoplegia, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| vasoplegic syndrome | Patients undergoing on-pump coronary artery bypass graft who develops vasoplegic syndrome 24 - 48 hours after surgery. Receives: Other: vasoplegic syndrome | |
| control | Patients undergoing on-pump coronary artery bypass graft who does not develop vasoplegic syndrome. Receives: Other: vasoplegic syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Profile of miRNA
Find out if it is possible to use mirna as a predictor of vasoplegic syndrome
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start28 Aug 2017
- Primary completion28 Dec 2019
- Study completion28 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasoplegic SyndromeStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, InCor Heart Institute
- Responsible party
- Sponsor
- Investigators
- Omar Mejía, Principal investigator, InCor Heart InstituteRenato Cesar de Souza, Principal investigator, InCor Heart InstituteEdecio Cunha-Neto, Principal investigator, InCor Heart InstituteFábio Jatene, Study chair, InCor Heart InstituteLudmila Ferreira, Principal investigator, Federal University of Minas GeraisBianca Meneguini, Principal investigator, InCor Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05354193
- Sponsor's protocol ID
- 4435/16/101
- Acronym
- PREVENT
- Status last verified
- Jan 2018
- First submitted
- 10 Jan 2018
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of microRNAs Expression in Patients Who Evolved to Vasoplegic Syndrome After On-pump Coronary Artery Bypass Surgery
- ClinicalTrials.gov ID
- NCT05354193
- Acronym / sponsor ID
- PREVENT / 4435/16/101
- Conditions
- Vasoplegic Syndrome, Vasoplegia, Surgery-Complications, Surgery, Cardiovascular Diseases, Cardiovascular Morbidity
- Keywords
- vasoplegic syndrome, vasoplegic, surgery, cardiovascular, microRNAs, miRNAs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, InCor Heart Institute
- Study start
- 28 Aug 2017 (actual)
- Primary completion
- 28 Dec 2019 (actual)
- Study completion
- 28 Dec 2019 (actual)
- First posted
- 29 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study looks for a correlation between microRNAs (miRNAs) and vasoplegic syndrome after on-pump coronary artery bypass surgery.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vasoplegic syndrome | – | Other: vasoplegic syndromePatients undergoing on-pump coronary artery bypass graft who develops vasoplegic syndrome 24 - 48 hours after surgery. |
| control | – | Other: vasoplegic syndromePatients undergoing on-pump coronary artery bypass graft who does not develop vasoplegic syndrome. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Our population is build whith both sexy, bigger than 18 years old, who has indication of coronary artery surgery. that was selected.
Key inclusion criteria (3 listed)
- Patients who go to coronary artery by-pass , on-pump surgery
- Patients who sign an informed consent
- Only elective or urgency surgery
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vasoplegic syndromeIn 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 | Other | control, vasoplegic syndrome |
Primary outcome
Profile of miRNA
Time frame: 6 months
Find out if it is possible to use mirna as a predictor of vasoplegic syndrome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omar Mejía principal investigator
InCor Heart Institute
Renato Cesar de Souza principal investigator
InCor Heart Institute
Edecio Cunha-Neto principal investigator
InCor Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vasoplegic Syndrome and Vasoplegia, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Profile of miRNA (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022.