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High-risk Patients in Cardiac Surgery Procedures: HiriSCORE

An International Multicenter Prospective Study for Identify High-risk Patients in Cardiac Surgery Procedures: HiriSCORE

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02560285
Acronym
HiriSCORE
Enrollment
3000
Registered
2015-09-25
Start date
2016-01-31
Completion date
2020-02-29
Last updated
2017-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C.Surgical Procedure; Cardiac

Keywords

Risk assessment, Mortality, Morbidity, Risk factor

Brief 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. 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.

Interventions

None listed

Sponsors

InCor Heart Institute
CollaboratorOTHER
Cardiology Institute of the Distrito Federal, Brazil
CollaboratorUNKNOWN
Clinical Hospital Samuel Libânio of Pouso Alegre, Brazil
CollaboratorUNKNOWN
Beneficência Portuguesa de São Paulo
CollaboratorOTHER
National Institute of Cardiology, Laranjeiras, Brazil
CollaboratorOTHER_GOV
Russian Cardiology Research and Production Center, Russia
CollaboratorUNKNOWN
Chinese Academy of Medical Sciences, Fuwai Hospital
CollaboratorOTHER
TotalCor Hospital, Brazil
CollaboratorUNKNOWN
Dante Pazzanese Institute of Cardiology, Brazil
CollaboratorUNKNOWN
Santa Casa de Misericórdia of Marília, Brazil
CollaboratorUNKNOWN
Hospital de Base
CollaboratorOTHER
Novosibirsk Cardiology Recearch and Production Center, Russia
CollaboratorUNKNOWN
University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Isolated surgery on ascending aorta, aortic arch or descending aorta * Heart transplantation * Impossibility to include patient´s data in research

Design outcomes

Primary

MeasureTime frameDescription
Mortality analysis30 daysPatient´s mortality data collection following 30 days after the main procedure

Secondary

MeasureTime frameDescription
ST-elevation Myocardial infarction30 daysST- elevation Myocardial infarction following 30 days after the main procedure
Non- ST- elevation Myocardial infarction30 daysNon- ST- elevation Myocardial infarction following 30 days after the main procedure
Deep sternal wound infection30 daysDeep sternal wound infection following 30 days after the main procedure
Bleeding requiring reoperation30 daysBleeding requiring reoperation following 30 days after the main procedure
Sepsis30 daysSepsis following 30 days after the main procedure
Stroke with neurological consequences (pareses or plegia)30 daysStroke with neurological consequences (pareses or plegia) following 30 days after the main procedure
Respiratory failure30 daysRespiratory failure following 30 days after the main procedure
Renal replacement therapy30 daysRenal replacement therapy following 30 days after the main procedure
Hepatic failure30 daysHepatic failure following 30 days after the main procedure
Unplanned cardiac reoperation30 daysUnplanned cardiac reoperation following 30 days after the main procedure
Unplanned cardiac percutaneous intervention30 daysUnplanned cardiac percutaneous intervention following 30 days after the main procedure
Endocarditis30 daysEndocarditis following 30 days after the main procedure

Countries

Brazil

Contacts

Primary ContactOmar AV Mejía, MD, PhD
omarvmejia@sbccv.org.br55-11-26615000
Backup ContactMaxim D Goncharov, MD
goncharovmaxim86@gmail.com55-11-976816107

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026