C.Surgical Procedure; CardiacHiriSCORENCT02560285
High-risk Patients in Cardiac Surgery Procedures: HiriSCORE
An observational study of C.Surgical Procedure; Cardiac, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Over time there is a need to improve old and develop new risk models. Overall the assessment of mortality risk in cardiac surgery is performed with the use of preoperative risk models. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- C.Surgical Procedure; Cardiac
- How many people
- 3,000 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2016to Feb 2020
- How long will I take part?
- 30 Days
- 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: Patients undergoing cardiac surgery procedures
Who may be able to join
- Patients undergoing cardiac surgery procedures, such as coronary artery bypass grafting, heart valve surgeries, co-operations on aorta and valve or CABG and variations of this procedures, regardless of the operation or treatment outcomes
- Mortality risk with STS score>5 or EuroSCORE II>5
Who cannot join
- Isolated surgery on ascending aorta, aortic arch or descending aorta
- Heart transplantation
- Impossibility to include patient´s data in research
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Fabio B Jatene, MD, PhD
São Paulo, 05409011
Omar AV Mejia, MD PhD, 11-996862043, omarvmejia@gmail.com
Maxim Dmitrievich Goncharov, MD, 11-976816107, goncharovmaxim86@gmail.com
About this study
Official title: An International Multicenter Prospective Study for Identify High-risk Patients in Cardiac Surgery Procedures: HiriSCORE
Over time there is a need to improve old and develop new risk models. Overall the assessment of mortality risk in cardiac surgery is performed with the use of preoperative risk models. The use of improved risk models and increased accuracy in the technique of preparing these mathematical systems does not have a positive impact on the level of prediction, which is still inaccurate, especially in the considered group of high risk. New models need to be built not only for a better prediction of mortality risk, if not also to predict morbidity in the group of patients at higher risk of complications after cardiac surgery procedures.
The aim of this study is:
- To construct the HiriSCORE to identify patients at higher risk of complications after cardiac surgery procedures
- Assessing the impact of pre-, intra- and postoperative period to the prognosis of morbidity and mortality in high-risk patients undergoing cardiac surgery procedures.
Read the detailed description
The risk predicts models are the mathematical tools for identification of the patients with complications risk after cardiac surgery procedures.
Over time, however, due to technical progress (the development of hybrid surgery, new valves and prostheses), the development of new drugs, changes in the environment and social conditions in which do patients live, there is a need to improve old and develop new models. Based on the statement that high risk patients have similar characteristics (clinical and laboratory) regardless of the procedure to which they were submitted, creating a new risk score to this group of patients must be sought. Improving the model quality was achieved by using more accurate risk assessments. In general, the assessment of mortality risk in cardiac surgery is performed with the use of preoperative risk models (EuroSCORE II, STS-score). However, the use of improved risk models and increased accuracy in the technique of preparing these mathematical systems, unfortunately, does not have a positive impact on the level of prediction, which is still inaccurate, especially in the considered group of high risk. New models need to be built not only for a better prediction of mortality risk, if not also to predict morbidity in the group of patients at higher risk of complications after cardiac surgery procedures.
The aim of this study is:
- To construct the HiriSCORE to identify patients at higher risk of complications after cardiac surgery procedures (the investigators have proposed a high-risk evaluation criteria: EuroSCORE II> 5 or STS-score> 5);
- Assessing the impact of pre-, intra- and postoperative period to the prognosis of subsequent morbidity and mortality in high-risk patients who have passed cardiac surgery procedures.
It was decided to conduct this research in two phases. The developmental phase is carried out for 30 months and includes an analysis of at least 2,000 patients who will pass cardiac surgery procedures in institutions and hospitals involved in the study. After this analysis, including outcomes, will be constructed the HiriSCORE, a new test-model for high-risk patients. In the validation phase of the study, which will involve a further 1,000 patients it is planned preparation and verification of effectiveness of the HiriSCORE model where it will be compared to the STS Score and the EuroSCORE II.
The study will include the patients of 18 years old or older who have undergone cardiac surgery procedures, such as coronary artery bypass grafting (isolated or combined with any heart valve intervention), heart valve surgery, and surgery on the ascending aorta (only combined with operations on the aortic valve or CABG).
Totally, it is proposed assessment of 170 variables (factors perceived risk) for each patient (preoperative, intraoperative, and up to 12 hours after surgery).
The study of mortality and postoperative complications such as renal replacement therapy, stroke, reoperation for bleeding, respiratory failure, cardiogenic shock, will be carried out within 30 days after cardiac surgery procedures.
- Conditions
- C.Surgical Procedure; Cardiac
- Keywords
- Risk assessment, Mortality, Morbidity, Risk factor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Development / 2000 participants | * Age >18 years; * Patients undergoing cardiac surgery procedures (elective, urgent or emergency) for CABG; heart valve surgery; CABG + heart valve surgery; ascending aorta surgery + heart valve surgery or CABG, who have mortality risk with STS score>5 or EuroSCORE II>5. | |
| Validation / 1000 participants | * Age >18 years; * Patients undergoing cardiac surgery procedures (elective, urgent or emergency) for CABG; heart valve surgery; CABG + heart valve surgery; ascending aorta surgery + heart valve surgery or CABG, who have mortality risk with STS score>5 or EuroSCORE II>5. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality analysis
Patient´s mortality data collection following 30 days after the main procedure
Measured: 30 days
Secondary outcomes (12)
Stroke with neurological consequences (pareses or plegia)
Stroke with neurological consequences (pareses or plegia) following 30 days after the main procedure
Measured: 30 days
ST-elevation Myocardial infarction
ST- elevation Myocardial infarction following 30 days after the main procedure
Measured: 30 days
Non- ST- elevation Myocardial infarction
Non- ST- elevation Myocardial infarction following 30 days after the main procedure
Measured: 30 days
Deep sternal wound infection
Deep sternal wound infection following 30 days after the main procedure
Measured: 30 days
Bleeding requiring reoperation
Bleeding requiring reoperation following 30 days after the main procedure
Measured: 30 days
Sepsis
Sepsis following 30 days after the main procedure
Measured: 30 days
Endocarditis
Endocarditis following 30 days after the main procedure
Measured: 30 days
Respiratory failure
Respiratory failure following 30 days after the main procedure
Measured: 30 days
Renal replacement therapy
Renal replacement therapy following 30 days after the main procedure
Measured: 30 days
Hepatic failure
Hepatic failure following 30 days after the main procedure
Measured: 30 days
Unplanned cardiac reoperation
Unplanned cardiac reoperation following 30 days after the main procedure
Measured: 30 days
Unplanned cardiac percutaneous intervention
Unplanned cardiac percutaneous intervention following 30 days after the main procedure
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study startJan 2016
- Primary completionSep 2017
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for C.Surgical Procedure; CardiacStudies 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
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- InCor Heart Institute, Cardiology Institute of the Distrito Federal, Brazil, Clinical Hospital Samuel Libânio of Pouso Alegre, Brazil, Beneficência Portuguesa de São Paulo, National Institute of Cardiology, Laranjeiras, Brazil, Russian Cardiology Research and Production Center, Chinese Academy of Medical Sciences, Fuwai Hospital, TotalCor Hospital, Brazil, Dante Pazzanese Institute of Cardiology, Brazil, Santa Casa de Misericórdia of Marília, Brazil, Hospital de Base, Novosibirsk Cardiology Recearch and Production Center, Russia
- Responsible party
- Sponsor
- Investigators
- Fábio B Jatene, MD, PhD, Study chair, Heart Institute of São Paulo Medical SchoolOmar AV Mejía, MD, PhD, Study director, Heart Institute of São Paulo Medical SchoolMaxim D Goncharov, MD, Principal investigator, Heart Institute of São Paulo Medical SchoolCamila PS Arthur, MD, Principal investigator, Heart Institute of São Paulo Medical SchoolRicardo R Dias, MD, PhD, Principal investigator, Heart Institute of São Paulo Medical SchoolCarlos MA Brandão, MD, PhD, Principal investigator, Heart Institute of São Paulo Medical SchoolRodrigo C Segalote, MD, Principal investigator, National Cardiology InstituteDiego M Ferreira, MD, Principal investigator, National Cardiology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02560285
- Sponsor's protocol ID
- USaoPauloGH1001
- Other IDs
- 1.289.986
- Acronym
- HiriSCORE
- Status last verified
- Oct 2017
- First submitted
- 30 Jun 2015
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: All data can be used by centers coparticipants after approval by the HiriSCORE group.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International Multicenter Prospective Study for Identify High-risk Patients in Cardiac Surgery Procedures: HiriSCORE
- ClinicalTrials.gov ID
- NCT02560285
- Acronym / sponsor ID
- HiriSCORE / USaoPauloGH1001
- Conditions
- C.Surgical Procedure; Cardiac
- Keywords
- Risk assessment, Mortality, Morbidity, Risk factor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- InCor Heart Institute, Cardiology Institute of the Distrito Federal, Brazil, Clinical Hospital Samuel Libânio of Pouso Alegre, Brazil, Beneficência Portuguesa de São Paulo, National Institute of Cardiology, Laranjeiras, Brazil, Russian Cardiology Research and Production Center, Chinese Academy of Medical Sciences, Fuwai Hospital, TotalCor Hospital, Brazil, Dante Pazzanese Institute of Cardiology, Brazil, Santa Casa de Misericórdia of Marília, Brazil, Hospital de Base, Novosibirsk Cardiology Recearch and Production Center, Russia
- Study start
- Jan 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Feb 2020 (estimated)
- First posted
- 25 Sep 2015 (estimated)
- 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.
Over time there is a need to improve old and develop new risk models. Overall the assessment of mortality risk in cardiac surgery is performed with the use of preoperative risk models. The use of improved risk models and increased accuracy in the technique of preparing these mathematical systems does not have a positive impact on the level of prediction, which is still inaccurate, especially in the considered group of high risk. New models need to be built not only for a better prediction of mortality risk, if not also to predict morbidity in the group of patients at higher risk of complications after cardiac surgery procedures.
The aim of this study is:
- To construct the HiriSCORE to identify patients at higher risk of complications after cardiac surgery procedures
- Assessing the impact of pre-, intra- and postoperative period to the prognosis of morbidity and mortality in high-risk patients undergoing cardiac surgery procedures.
Detailed description
The risk predicts models are the mathematical tools for identification of the patients with complications risk after cardiac surgery procedures.
Over time, however, due to technical progress (the development of hybrid surgery, new valves and prostheses), the development of new drugs, changes in the environment and social conditions in which do patients live, there is a need to improve old and develop new models. Based on the statement that high risk patients have similar characteristics (clinical and laboratory) regardless of the procedure to which they were submitted, creating a new risk score to this group of patients must be sought. Improving the model quality was achieved by using more accurate risk assessments. In general, the assessment of mortality risk in cardiac surgery is performed with the use of preoperative risk models (EuroSCORE II, STS-score). However, the use of improved risk models and increased accuracy in the technique of preparing these mathematical systems, unfortunately, does not have a positive impact on the level of prediction, which is still inaccurate, especially in the considered group of high risk. New models need to be built not only for a better prediction of mortality risk, if not also to predict morbidity in the group of patients at higher risk of complications after cardiac surgery procedures.
The aim of this study is:
- To construct the HiriSCORE to identify patients at higher risk of complications after cardiac surgery procedures (the investigators have proposed a high-risk evaluation criteria: EuroSCORE II> 5 or STS-score> 5);
- Assessing the impact of pre-, intra- and postoperative period to the prognosis of subsequent morbidity and mortality in high-risk patients who have passed cardiac surgery procedures.
It was decided to conduct this research in two phases. The developmental phase is carried out for 30 months and includes an analysis of at least 2,000 patients who will pass cardiac surgery procedures in institutions and hospitals involved in the study. After this analysis, including outcomes, will be constructed the HiriSCORE, a new test-model for high-risk patients. In the validation phase of the study, which will involve a further 1,000 patients it is planned preparation and verification of effectiveness of the HiriSCORE model where it will be compared to the STS Score and the EuroSCORE II.
The study will include the patients of 18 years old or older who have undergone cardiac surgery procedures, such as coronary artery bypass grafting (isolated or combined with any heart valve intervention), heart valve surgery, and surgery on the ascending aorta (only combined with operations on the aortic valve or CABG).
Totally, it is proposed assessment of 170 variables (factors perceived risk) for each patient (preoperative, intraoperative, and up to 12 hours after surgery).
The study of mortality and postoperative complications such as renal replacement therapy, stroke, reoperation for bleeding, respiratory failure, cardiogenic shock, will be carried out within 30 days after cardiac surgery procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Development / 2000 participants | – | –* Age >18 years; * Patients undergoing cardiac surgery procedures (elective, urgent or emergency) for CABG; heart valve surgery; CABG + heart valve surgery; ascending aorta surgery + heart valve surgery or CABG, who have mortality risk with STS score>5 or EuroSCORE II>5. |
| Validation / 1000 participants | – | –* Age >18 years; * Patients undergoing cardiac surgery procedures (elective, urgent or emergency) for CABG; heart valve surgery; CABG + heart valve surgery; ascending aorta surgery + heart valve surgery or CABG, who have mortality risk with STS score>5 or EuroSCORE II>5. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing cardiac surgery procedures
Key inclusion criteria (2 listed)
- Patients undergoing cardiac surgery procedures, such as coronary artery bypass grafting, heart valve surgeries, co-operations on aorta and valve or CABG and variations of this procedures, regardless of the operation or treatment outcomes
- Mortality risk with STS score>5 or EuroSCORE II>5
Key exclusion criteria (3 listed)
- Isolated surgery on ascending aorta, aortic arch or descending aorta
- Heart transplantation
- Impossibility to include patient´s data in research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality analysis
Time frame: 30 days
Patient´s mortality data collection following 30 days after the main procedure
12 secondary outcomes
Stroke with neurological consequences (pareses or plegia)
Time frame: 30 days
ST-elevation Myocardial infarction
Time frame: 30 days
Non- ST- elevation Myocardial infarction
Time frame: 30 days
Deep sternal wound infection
Time frame: 30 days
Bleeding requiring reoperation
Time frame: 30 days
Sepsis
Time frame: 30 days
Endocarditis
Time frame: 30 days
Respiratory failure
Time frame: 30 days
Renal replacement therapy
Time frame: 30 days
Hepatic failure
Time frame: 30 days
Unplanned cardiac reoperation
Time frame: 30 days
Unplanned cardiac percutaneous intervention
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Individual participant dataSharing planned: Yes. All data can be used by centers coparticipants after approval by the HiriSCORE group.
Related trials for C.Surgical Procedure; Cardiac
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Acute Normovolemic Hemodilution in High Risk Cardiac Surgery Patients.
C.Surgical Procedure; Cardiac
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.
Fábio B Jatene, MD, PhD study chair
Heart Institute of São Paulo Medical School
Omar AV Mejía, MD, PhD study director
Heart Institute of São Paulo Medical School
Maxim D Goncharov, MD principal investigator
Heart Institute of São Paulo Medical School
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 C.Surgical Procedure; Cardiac, 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 6 Nov 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Omar AV Mejía, MD, PhD (55-11-26615000 ext. 5014, omarvmejia@sbccv.org.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality analysis (time frame: 30 days). 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 6 Nov 2017.