High-risk Patients in Cardiac Surgery Procedures: HiriSCORE

NCT02560285 | Unknown DMC

• 2 other identifiers: USaoPauloGH10011.289.986
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

C.Surgical Procedure; Cardiac

Keywords

Risk assessment; Mortality; Morbidity; Risk factor

Outcome Measures

Primary Outcomes (1)

• Mortality analysis

  Patient´s mortality data collection following 30 days after the main procedure

  30 days

Secondary Outcomes (12)

• Stroke with neurological consequences (pareses or plegia)

  30 days

• ST-elevation Myocardial infarction

  30 days

• Non- ST- elevation Myocardial infarction

  30 days

• Deep sternal wound infection

  30 days

• Bleeding requiring reoperation

  30 days

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing cardiac surgery procedures

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Fabio B Jatene, MD, PhD

São Paulo, 05409011, Brazil

RECRUITING

Study Officials

• 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

• 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

Central Study Contacts

Omar AV Mejía, MD, PhD

CONTACT

55-11-26615000; omarvmejia@sbccv.org.br

Maxim D Goncharov, MD

CONTACT

55-11-976816107; goncharovmaxim86@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2015
• First Posted: September 25, 2015
• Study Start: January 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: February 1, 2020
• Last Updated: November 6, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)