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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Maxim D Goncharov, MD contact

55-11-976816107

goncharovmaxim86@gmail.com

Brazil1 site, 1 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

    Recruiting

Other trials in Brazil

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.

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 groups in NCT02560285
Study groupRoleWhat 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.

  1. Mortality analysis

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

    Measured: 30 days

Secondary outcomes (12)
  1. Stroke with neurological consequences (pareses or plegia)

    Stroke with neurological consequences (pareses or plegia) following 30 days after the main procedure

    Measured: 30 days

  2. ST-elevation Myocardial infarction

    ST- elevation Myocardial infarction following 30 days after the main procedure

    Measured: 30 days

  3. Non- ST- elevation Myocardial infarction

    Non- ST- elevation Myocardial infarction following 30 days after the main procedure

    Measured: 30 days

  4. Deep sternal wound infection

    Deep sternal wound infection following 30 days after the main procedure

    Measured: 30 days

  5. Bleeding requiring reoperation

    Bleeding requiring reoperation following 30 days after the main procedure

    Measured: 30 days

  6. Sepsis

    Sepsis following 30 days after the main procedure

    Measured: 30 days

  7. Endocarditis

    Endocarditis following 30 days after the main procedure

    Measured: 30 days

  8. Respiratory failure

    Respiratory failure following 30 days after the main procedure

    Measured: 30 days

  9. Renal replacement therapy

    Renal replacement therapy following 30 days after the main procedure

    Measured: 30 days

  10. Hepatic failure

    Hepatic failure following 30 days after the main procedure

    Measured: 30 days

  11. Unplanned cardiac reoperation

    Unplanned cardiac reoperation following 30 days after the main procedure

    Measured: 30 days

  12. 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.

  1. First posted25 Sep 2015 (estimated)
  2. Study startJan 2016
  3. Primary completionSep 2017
  4. Study completionFeb 2020 (estimated)

Resources

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
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.

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.

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