Myocardial InfarctionNCT05532917
Cardiology Consultation in Noncardiac Surgery
An observational study of Myocardial Infarction and Surgery-Complications, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Myocardial Infarction, Surgery-Complications
- What is being tested?
- Gupta score
- How many people
- 898 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2022to 12 Apr 2023
- How long will I take part?
- 1 Month
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients undergoing non-cardiovascular surgery
- Patients evaluated routinely preoperatively in the anesthesiologist preoperative outpatient clinic
Who cannot join
- Emergency surgeries
- ASA Physical Status V
- Patients undergoing cardiovascular surgery
- Minor surgeries
- Patients who did not want to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Medical Science, Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey
Altındağ, Ankara, 06000
About this study
Official title: Impact of 2014 ACC/AHA Perioperative Guidelines on Cardiological Resource Use in Noncardiac Surgery Patients
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.
Read the detailed 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.
- Conditions
- Myocardial Infarction, Surgery-Complications
- Being tested
- Gupta score
- Keywords
- ACC/AHA guidelines, Perioperative cardiac risk, Cardiology consultation
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gupta scoreOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Gupta group | Cardiology consultation requested using Gupta score Receives: Other: Gupta score | |
| Non-Gupta group | Number of cardiology consultations requested without using Gupta score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gupta score
The frequency of cardiology consultation requests will be compared according to the use of the Gupta score.
Measured: perioperative period
Secondary outcomes (1)
Perioperative clinical results
Perioperative clinical results (coronary angiography, ECHO, acute coronary syndrome, arrhythmia, 30-day mortality, etc.) will be evaluated.
Measured: perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start15 Jan 2022
- Primary completion31 Mar 2023
- Study completion12 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Time perspective
- Prospective
- Enrolment
- 898 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Funda Atar, Diskapi Yildirim Beyazit Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05532917
- Sponsor's protocol ID
- 10.1.2022 128/21
- Status last verified
- Apr 2023
- First submitted
- 5 Sep 2022
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17906472Glance 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.
PubMed 30001221Madi-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.
PubMed 19879104
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of 2014 ACC/AHA Perioperative Guidelines on Cardiological Resource Use in Noncardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT05532917
- Acronym / sponsor ID
- 10.1.2022 128/21
- Conditions
- Myocardial Infarction, Surgery-Complications
- Keywords
- ACC/AHA guidelines, Perioperative cardiac risk, Cardiology consultation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 898 participants (actual)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 12 Apr 2023 (actual)
- First posted
- 8 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gupta group | – | Other: Gupta scoreCardiology consultation requested using Gupta score |
| Non-Gupta group | – | –Number of cardiology consultations requested without using Gupta score |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients undergoing non-cardiovascular surgery
- Patients evaluated routinely preoperatively in the anesthesiologist preoperative outpatient clinic
Key exclusion criteria (5 listed)
- Emergency surgeries
- ASA Physical Status V
- Patients undergoing cardiovascular surgery
- Minor surgeries
- Patients who did not want to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gupta scoreThe 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. | Other | Gupta group |
Primary outcome
Gupta score
Time frame: perioperative period
The frequency of cardiology consultation requests will be compared according to the use of the Gupta score.
1 secondary outcome
Perioperative clinical results
Time frame: perioperative period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Background: PubMed 17906472Cinello 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.
- Background: PubMed 30001221Glance 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.
- Background: PubMed 19879104Madi-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction and Surgery-Complications, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
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 5 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: finished, as of the sponsor's last update on 13 Apr 2023. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gupta score (time frame: perioperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05532917, which also lists 3 linked publications.
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 13 Apr 2023.