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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05532917
Other study ID # 10.1.2022 128/21
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 15, 2022
Est. completion date April 12, 2023

Study information

Verified date April 2023
Source Diskapi Yildirim Beyazit Education and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Description:

All patients undergoing non-cardiac surgery are at risk of major perioperative cardiovascular events. Cardiac complications account for 42% of the overall complications of these surgeries. Therefore, cardiologists are the most frequently consulted specialists in preoperative evaluation. Unnecessary cardiology consultations may cause comments that will not affect the practice of anesthesia, inappropriate tests and interventions, and delay in the surgical procedure. 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.


Recruitment information / eligibility

Status Completed
Enrollment 898
Est. completion date April 12, 2023
Est. primary completion date March 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Patients undergoing non-cardiovascular surgery - Patients evaluated routinely preoperatively in the anesthesiologist preoperative outpatient clinic Exclusion Criteria: - Emergency surgeries - ASA Physical Status V - Patients undergoing cardiovascular surgery - Minor surgeries - Patients who did not want to participate in the study

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Gupta score
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.

Locations

Country Name City State
Turkey University of Medical Science, Yildirim Beyazit Training and Research Hospital, Ankara, Turkey Altindag Ankara

Sponsors (1)

Lead Sponsor Collaborator
Diskapi Yildirim Beyazit Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Gupta score The frequency of cardiology consultation requests will be compared according to the use of the Gupta score. perioperative period
Secondary Perioperative clinical results Perioperative clinical results (coronary angiography, ECHO, acute coronary syndrome, arrhythmia, 30-day mortality, etc.) will be evaluated. perioperative period
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