High-risk Patients in Cardiac Surgery Procedures: HiriSCORE

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2020-02-29

Brief Summary

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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:

* 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

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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

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C.Surgical Procedure; Cardiac

Keywords

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Risk assessment Mortality Morbidity Risk factor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fábio B Jatene, MD, PhD

Role: STUDY_CHAIR

Heart Institute of São Paulo Medical School

Omar AV Mejía, MD, PhD

Role: STUDY_DIRECTOR

Heart Institute of São Paulo Medical School

Maxim D Goncharov, MD

Role: PRINCIPAL_INVESTIGATOR

Heart Institute of São Paulo Medical School

Camila PS Arthur, MD

Role: PRINCIPAL_INVESTIGATOR

Heart Institute of São Paulo Medical School

Ricardo R Dias, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Heart Institute of São Paulo Medical School

Carlos MA Brandão, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Heart Institute of São Paulo Medical School

Rodrigo C Segalote, MD

Role: PRINCIPAL_INVESTIGATOR

National Cardiology Institute

Diego M Ferreira, MD

Role: PRINCIPAL_INVESTIGATOR

National Cardiology Institute

Marcos G Tiveron, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Santa Casa de Misericórdia of Marília

Helton A Bomfim, N

Role: PRINCIPAL_INVESTIGATOR

Santa Casa de Misericórdia of Marília

Renat Suleimanovich Akchurin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Russian Cardiology Research and Production Center

Elina Evgenievna Vlasova, MD

Role: PRINCIPAL_INVESTIGATOR

Russian Cardiology Research and Production Center

Pedro Gabriel M de Barros e Silva, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

TotalCor Hospital

João Galantier, MD

Role: PRINCIPAL_INVESTIGATOR

TotalCor Hospital

Alexandre C Hueb, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Hospital Samuel Libânio of Pouso Alegre

Maurício LJ Guerrieri, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Hospital Samuel Libânio of Pouso Alegre

Marcelo A Nakazone, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Base of São José de Rio Preto

Mauricio N Machado, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Base of São José de Rio Preto

Fernando A Atik, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cardiology Institute of the Distrito Federal

Murilo T Macedo, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiology Institute of the Distrito Federal

Luís RP Dallan, MD

Role: PRINCIPAL_INVESTIGATOR

Heart Institute of São Paulo Medical School

José AD Santiago, MD

Role: PRINCIPAL_INVESTIGATOR

Heart Institute of São Paulo Medical School

Elinthon T Veronese, MD

Role: PRINCIPAL_INVESTIGATOR

Heart Institute of São Paulo Medical School

Pablo MA Pomerantzeff, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Heart Institute of São Paulo Medical School

Luiz Augusto F Lisboa, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Heart Institute of São Paulo Medical School

Luís Alberto O Dallan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Heart Institute of São Paulo Medical School

Shengshou Hu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fuwai Hospital and Cardiovascular Institute

Zhe Zheng, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fuwai Hospital and Cardiovascular Institute

Heng Zhang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fuwai Hospital and Cardiovascular Institute

Alexander Bogachev-Prokofiev, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Novosibirsk Cardiology Recearch and Production Complex

Magaly Arrais dos Santos, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto Dante Pazzanese de Cardiologia

Jenny Rivas de Oliveira, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Dante Pazzanese de Cardiologia

Luiz C Bento de Souza, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto Dante Pazzanese de Cardiologia

Jóse H Palma da Fonseca, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Heart Institute of São Paulo Medical School

Filomena Regina BG Galas, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Heart Institute of São Paulo Medical School

Ludhmila A Hajjar, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Heart Institute of São Paulo Medical School

Roberto Kalil Filho, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Heart Institute of São Paulo Medical School

Locations

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Fabio B Jatene, MD, PhD

São Paulo, , Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Omar AV Mejía, MD, PhD

Role: CONTACT

Phone: 55-11-26615000

Email: [email protected]

Maxim D Goncharov, MD

Role: CONTACT

Phone: 55-11-976816107

Email: [email protected]

Facility Contacts

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Omar AV Mejia, MD PhD

Role: primary

Maxim Dmitrievich Goncharov, MD

Role: backup

Other Identifiers

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1.289.986

Identifier Type: OTHER

Identifier Source: secondary_id

USaoPauloGH1001

Identifier Type: -

Identifier Source: org_study_id

High-risk Patients in Cardiac Surgery Procedures: HiriSCORE

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Development / 2000 participants

Validation / 1000 participants

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

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, Russia

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

University of Sao Paulo General Hospital

Responsible Party

Principal Investigators

Fábio B Jatene, MD, PhD

Omar AV Mejía, MD, PhD

Maxim D Goncharov, MD

Camila PS Arthur, MD

Ricardo R Dias, MD, PhD

Carlos MA Brandão, MD, PhD

Rodrigo C Segalote, MD

Diego M Ferreira, MD

Marcos G Tiveron, MD, PhD

Helton A Bomfim, N

Renat Suleimanovich Akchurin, MD, PhD

Elina Evgenievna Vlasova, MD

Pedro Gabriel M de Barros e Silva, MD, PhD

João Galantier, MD

Alexandre C Hueb, MD,PhD

Maurício LJ Guerrieri, MD

Marcelo A Nakazone, MD, PhD

Mauricio N Machado, MD, PhD

Fernando A Atik, MD, PhD

Murilo T Macedo, MD

Luís RP Dallan, MD

José AD Santiago, MD

Elinthon T Veronese, MD

Pablo MA Pomerantzeff, MD, PhD

Luiz Augusto F Lisboa, MD, PhD

Luís Alberto O Dallan, MD, PhD

Shengshou Hu, MD, PhD

Zhe Zheng, MD, PhD

Heng Zhang, MD, PhD

Alexander Bogachev-Prokofiev, MD, PhD

Magaly Arrais dos Santos, MD, PhD

Jenny Rivas de Oliveira, MD

Luiz C Bento de Souza, MD, PhD

Jóse H Palma da Fonseca, MD, PhD

Filomena Regina BG Galas, MD, PhD

Ludhmila A Hajjar, MD, PhD

Roberto Kalil Filho, MD, PhD

Locations

Fabio B Jatene, MD, PhD

Countries

Central Contacts

Omar AV Mejía, MD, PhD

Maxim D Goncharov, MD

Facility Contacts

Omar AV Mejia, MD PhD

Maxim Dmitrievich Goncharov, MD

Other Identifiers

1.289.986

USaoPauloGH1001