NCT05532917

Brief Summary

Recently, a predictive model has been developed to assess the risk of myocardial infarction or cardiac arrest (MICA) during and after surgery using the American Society of Surgeons' National Surgical Quality Improvement Program (NSQIP) database. In this MICA model, 180 hospital databases were used in 2007 and 2008 and included more than 200 000 patients. The Gupta score developed with this MICA model identified five predictors of perioperative myocardial infarction and cardiac arrest: type of surgery, functional status, creatinine increase (\>130 mmol/L or \>1.5 mg/dL), age, and American Association of Anesthesiologists (ASA) class. The Gupta score is presented as an interactive risk calculation program in the 2014 guideline of the ACC/AHA. The risk can be calculated simply and accurately at the bedside or clinic. The Gupta score is in spreadsheet format and can be downloaded online at http://www.surgicalriskcalculator.com/miorcardiacarrest. Unlike the previously used indexes, a scoring system has not been established. An estimate of the probability of myocardial infarction/cardiac arrest is provided for individual patients. In this study, the primary aim was to compare the frequency of cardiology consultation requests according to the use of the Gupta score. The secondary aim is to evaluate the perioperative clinical results (coronary angiography, ECHO, acute coronary syndrome, arrhythmia, 30-day mortality, etc.).SPSS 21.0 (Version 22.0, SPSS, Inc, Chicago, IL, USA) program will be used for statistical analysis. After applying the Shapiro-Wilk test for normality, the student's t-test will be used if the distribution is normal, and the Mann-Whitey U test will be used if the distribution is not normal. Fisher's exact test or chi-square test will be used for categorical variables. Results p\<0.05 will be considered significant.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
898

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 8, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2023

Completed
Last Updated

April 13, 2023

Status Verified

April 1, 2023

Enrollment Period

1.2 years

First QC Date

September 5, 2022

Last Update Submit

April 12, 2023

Conditions

Keywords

ACC/AHA guidelinesPerioperative cardiac riskCardiology consultation

Outcome Measures

Primary Outcomes (1)

  • Gupta score

    The frequency of cardiology consultation requests will be compared according to the use of the Gupta score.

    perioperative period

Secondary Outcomes (1)

  • Perioperative clinical results

    perioperative period

Study Arms (2)

Gupta group

Cardiology consultation requested using Gupta score

Other: Gupta score

Non-Gupta group

Number of cardiology consultations requested without using Gupta score

Interventions

The Gupta score is presented as an interactive risk calculation program in the 2014 guideline of the ACC/AHA. The Gupta score developed with this MICA model identified five predictors of perioperative myocardial infarction and cardiac arrest: type of surgery, functional status, creatinine increase (\>130 mmol/L or \>1.5 mg/dL), age, and American Association of Anesthesiologists (ASA) class. The frequency of cardiology consultation requests will be investigated according to the use of the Gupta score.

Gupta group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients over the age of 18 who will be referred to the anesthesia polyclinic and will undergo non-cardiac surgery will be included in the study. Cardiology consultation will be requested from these patients according to the Gupta score. Additional tests or examinations may be requested if the cardiologist deems it necessary.

You may qualify if:

  • Patients undergoing non-cardiovascular surgery
  • Patients evaluated routinely preoperatively in the anesthesiologist preoperative outpatient clinic

You may not qualify if:

  • Emergency surgeries
  • ASA Physical Status V
  • Patients undergoing cardiovascular surgery
  • Minor surgeries
  • Patients who did not want to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Medical Science, Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey

Altındağ, Ankara, 06000, Turkey (Türkiye)

Location

Related Publications (3)

  • Cinello M, Nucifora G, Bertolissi M, Badano LP, Fresco C, Gonano N, Fioretti PM. American College of Cardiology/American Heart Association perioperative assessment guidelines for noncardiac surgery reduces cardiologic resource utilization preserving a favourable clinical outcome. J Cardiovasc Med (Hagerstown). 2007 Nov;8(11):882-8. doi: 10.2459/JCM.0b013e3280122d63.

    PMID: 17906472BACKGROUND
  • Glance LG, Faden E, Dutton RP, Lustik SJ, Li Y, Eaton MP, Dick AW. Impact of the Choice of Risk Model for Identifying Low-risk Patients Using the 2014 American College of Cardiology/American Heart Association Perioperative Guidelines. Anesthesiology. 2018 Nov;129(5):889-900. doi: 10.1097/ALN.0000000000002341.

    PMID: 30001221BACKGROUND
  • Madi-Jebara S, Chalhoub V, Jabbour K, Yazigi A, Haddad F, Richa F, El-Hage C, Yazbeck P. [Audit on preoperative cardiac evaluation before non-cardiac surgery: the importance of a pocket guide to improve the anaesthesist's adhesion to ACC/AHA guidelines]. Ann Fr Anesth Reanim. 2009 Oct;28(10):850-4. doi: 10.1016/j.annfar.2009.08.007. Epub 2009 Oct 29. French.

    PMID: 19879104BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 5, 2022

First Posted

September 8, 2022

Study Start

January 15, 2022

Primary Completion

March 31, 2023

Study Completion

April 12, 2023

Last Updated

April 13, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations