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| ID | Type | Description | Link |
|---|---|---|---|
| 1.289.986 | Other Identifier | Ethics Committee for the Analysis of Research Projects |
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| Name | Class |
|---|---|
| InCor Heart Institute | OTHER |
| Cardiology Institute of the Distrito Federal, Brazil | UNKNOWN |
| Clinical Hospital Samuel Libânio of Pouso Alegre, Brazil | UNKNOWN |
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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Development / 2000 participants |
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| Validation / 1000 participants |
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| Measure | Description | Time Frame |
|---|---|---|
| Mortality analysis | Patient´s mortality data collection following 30 days after the main procedure | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Stroke with neurological consequences (pareses or plegia) | Stroke with neurological consequences (pareses or plegia) following 30 days after the main procedure | 30 days |
| ST-elevation Myocardial infarction |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing cardiac surgery procedures
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Omar AV Mejía, MD, PhD | Contact | 55-11-26615000 | 5014 | omarvmejia@sbccv.org.br |
| Maxim D Goncharov, MD | Contact | 55-11-976816107 | goncharovmaxim86@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Fábio B Jatene, MD, PhD | Heart Institute of São Paulo Medical School | Study Chair |
| Omar AV Mejía, MD, PhD | Heart Institute of São Paulo Medical School | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fabio B Jatene, MD, PhD | Recruiting | São Paulo | 05409011 | Brazil |
All data can be used by centers coparticipants after approval by the HiriSCORE group.
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| Beneficência Portuguesa de São Paulo |
| OTHER |
| National Institute of Cardiology, Laranjeiras, Brazil | OTHER_GOV |
| Russian Cardiology Research and Production Center | OTHER |
| Chinese Academy of Medical Sciences, Fuwai Hospital | OTHER |
| TotalCor Hospital, Brazil | UNKNOWN |
| Dante Pazzanese Institute of Cardiology, Brazil | UNKNOWN |
| Santa Casa de Misericórdia of Marília, Brazil | UNKNOWN |
| Hospital de Base | OTHER |
| Novosibirsk Cardiology Recearch and Production Center, Russia | UNKNOWN |
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ST- elevation Myocardial infarction following 30 days after the main procedure
| 30 days |
| Non- ST- elevation Myocardial infarction | Non- ST- elevation Myocardial infarction following 30 days after the main procedure | 30 days |
| Deep sternal wound infection | Deep sternal wound infection following 30 days after the main procedure | 30 days |
| Bleeding requiring reoperation | Bleeding requiring reoperation following 30 days after the main procedure | 30 days |
| Sepsis | Sepsis following 30 days after the main procedure | 30 days |
| Endocarditis | Endocarditis following 30 days after the main procedure | 30 days |
| Respiratory failure | Respiratory failure following 30 days after the main procedure | 30 days |
| Renal replacement therapy | Renal replacement therapy following 30 days after the main procedure | 30 days |
| Hepatic failure | Hepatic failure following 30 days after the main procedure | 30 days |
| Unplanned cardiac reoperation | Unplanned cardiac reoperation following 30 days after the main procedure | 30 days |
| Unplanned cardiac percutaneous intervention | Unplanned cardiac percutaneous intervention following 30 days after the main procedure | 30 days |
| Maxim D Goncharov, MD |
| Heart Institute of São Paulo Medical School |
| Principal Investigator |
| Camila PS Arthur, MD | Heart Institute of São Paulo Medical School | Principal Investigator |
| Ricardo R Dias, MD, PhD | Heart Institute of São Paulo Medical School | Principal Investigator |
| Carlos MA Brandão, MD, PhD | Heart Institute of São Paulo Medical School | Principal Investigator |
| Rodrigo C Segalote, MD | National Cardiology Institute | Principal Investigator |
| Diego M Ferreira, MD | National Cardiology Institute | Principal Investigator |
| Marcos G Tiveron, MD, PhD | Santa Casa de Misericórdia of Marília | Principal Investigator |
| Helton A Bomfim, N | Santa Casa de Misericórdia of Marília | Principal Investigator |
| Renat Suleimanovich Akchurin, MD, PhD | Russian Cardiology Research and Production Center | Principal Investigator |
| Elina Evgenievna Vlasova, MD | Russian Cardiology Research and Production Center | Principal Investigator |
| Pedro Gabriel M de Barros e Silva, MD, PhD | TotalCor Hospital | Principal Investigator |
| João Galantier, MD | TotalCor Hospital | Principal Investigator |
| Alexandre C Hueb, MD,PhD | Clinical Hospital Samuel Libânio of Pouso Alegre | Principal Investigator |
| Maurício LJ Guerrieri, MD | Clinical Hospital Samuel Libânio of Pouso Alegre | Principal Investigator |
| Marcelo A Nakazone, MD, PhD | Hospital de Base of São José de Rio Preto | Principal Investigator |
| Mauricio N Machado, MD, PhD | Hospital de Base of São José de Rio Preto | Principal Investigator |
| Fernando A Atik, MD, PhD | Cardiology Institute of the Distrito Federal | Principal Investigator |
| Murilo T Macedo, MD | Cardiology Institute of the Distrito Federal | Principal Investigator |
| Luís RP Dallan, MD | Heart Institute of São Paulo Medical School | Principal Investigator |
| José AD Santiago, MD | Heart Institute of São Paulo Medical School | Principal Investigator |
| Elinthon T Veronese, MD | Heart Institute of São Paulo Medical School | Principal Investigator |
| Pablo MA Pomerantzeff, MD, PhD | Heart Institute of São Paulo Medical School | Principal Investigator |
| Luiz Augusto F Lisboa, MD, PhD | Heart Institute of São Paulo Medical School | Principal Investigator |
| Luís Alberto O Dallan, MD, PhD | Heart Institute of São Paulo Medical School | Principal Investigator |
| Shengshou Hu, MD, PhD | Fuwai Hospital and Cardiovascular Institute | Principal Investigator |
| Zhe Zheng, MD, PhD | Fuwai Hospital and Cardiovascular Institute | Principal Investigator |
| Heng Zhang, MD, PhD | Fuwai Hospital and Cardiovascular Institute | Principal Investigator |
| Alexander Bogachev-Prokofiev, MD, PhD | Novosibirsk Cardiology Recearch and Production Complex | Principal Investigator |
| Magaly Arrais dos Santos, MD, PhD | Instituto Dante Pazzanese de Cardiologia | Principal Investigator |
| Jenny Rivas de Oliveira, MD | Instituto Dante Pazzanese de Cardiologia | Principal Investigator |
| Luiz C Bento de Souza, MD, PhD | Instituto Dante Pazzanese de Cardiologia | Principal Investigator |
| Jóse H Palma da Fonseca, MD, PhD | Heart Institute of São Paulo Medical School | Principal Investigator |
| Filomena Regina BG Galas, MD, PhD | Heart Institute of São Paulo Medical School | Principal Investigator |
| Ludhmila A Hajjar, MD, PhD | Heart Institute of São Paulo Medical School | Principal Investigator |
| Roberto Kalil Filho, MD, PhD | Heart Institute of São Paulo Medical School | Principal Investigator |