Cardiac IschemiaNCT05453097
Prognostic Value of the Selvester QRS Score for Perioperative Myocardial Injury Following Non-cardiac Surgery
An observational study of Cardiac Ischemia and Cardiac Arrhythmia, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study to determine the prognostic value of the Selvester QRS score for perioperative myocardial injury following elective non-cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cardiac Ischemia, Cardiac Arrhythmia, Perioperative Injury
- What is being tested?
- Selvester QRS Score with Preoperative ECG
- How many people
- 400 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Aug 2022to 30 Nov 2023
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will be conducted on patients aged 18-90 years who have had elective surgery (besides cardiac operations) performed by a surgeon in the operating rooms of a tertiary university hospital, whose ECG before the operation is interpretable, and whose troponin value is measured before and after the operation.
Who may be able to join
- Patients who undergoing elective non-cardiac surgery in the operating room
- ≥18 years old
- Interpretable preoperative ECG of the patient
- Preoperative negative high sensitive Cardiac Troponin T
- ASA I-III class
- Patients who give the informed consent
Who cannot join
- A history of myocardial infarction, coronary artery disease, PCI and revascularization
- A history of chronic renal disease, cerebrovascular incident, stroke
- ASA class IV
- Patients who do not give the informed consent
- Patients who undergoing emergency surgery
- Patients whose preoperative ECG is not interpretable
- Minor procedures to be performed outside or inside the operating room
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa
Istanbul, Fatih, 34098
About this study
The purpose of this study to determine the prognostic value of the Selvester QRS score for perioperative myocardial injury following elective non-cardiac surgery.
Read the detailed description
This study was designed as an investigator-directed, non-commercial, observational, prospective, national, single-center study. The effect of preoperative complex ECG changes on the formation of cardiac damage will be studied. The data of the people participating in the study will be kept entirely confidential. After being informed about the study, all patients giving written informed consent will undergo preoperative evaluation. An ECG and cardiac troponin analysis will be performed to the patients who meet the eligibility. After the surgery will be completed control cardiac troponin and extensive physical examination will be performed.
- Being tested
- Selvester QRS Score with Preoperative ECG
- Keywords
- myocardial injury, Perioperative injury
- Medical subject headings
- Coronary Artery Disease, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selvester QRS Score with Preoperative ECGDiagnostic test
Selvester QRS score will be calculated with the preoperative ECG of the patients.
| Study group | Role | What they receive |
|---|---|---|
| Perioperative Myocardial Injury Occured | Patients with troponin elevation from the preoperative basal level do not meet the criteria for myocardial infarction according to the fourth universal myocardial infarction guideline, do not describe active anginal complaints, and underwent surgery in the operating room. Receives: Diagnostic Test: Selvester QRS Score with Preoperative ECG | |
| Perioperative Myocardial Injury Not Occured | Patients without troponin elevation from the preoperative basal level, do not describe active anginal complaints, and underwent surgery in the operating room. Receives: Diagnostic Test: Selvester QRS Score with Preoperative ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prediction of perioperative cardiac injury with preoperative Selvester ECG Score
Selvester ECG score is a validated technique for predicting myocardial scar and injury level in patients who undergone PCI. It is aimed to predict and demonstrate perioperative myocardial damage using this algorithm.
Measured: Change from Baseline cardiac troponin levels at postoperative 1st hour in PACU
Secondary outcomes (3)
The prediction of preoperative high-sensitivity troponin and ECG abnormalities on arrhythmia susceptibility.
The prediction of preoperative high-sensitivity troponin and ECG abnormalities on arrhythmia susceptibility by monitoring the cardiac rhythm
Measured: Arrhythmia surveillance during peroperative and postoperative 1st hour in PACU
Effect of preoperative cardiac assessment on postoperative cardiac adverse event
Effect of preoperative cardiac assessment on postoperative cardiac adverse event
Measured: Cardiac adverse event surveillance during peroperative and postoperative 24 hours
Determination of postoperative intensive care hospitalizations for cardiac reasons
Determination of the reasons of the postoperative intensive care unit hospitalizations for cardiac reasons.
Measured: postoperative intensive care hospitalizations for cardiac reasons until postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start11 Aug 2022
- Primary completion26 Sep 2023
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiac IschemiaStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deniz Mutlu, Istanbul University - Cerrahpasa
- Investigators
- Kivanc Yalin, MD, Study chair, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05453097
- Sponsor's protocol ID
- 2022/172
- Status last verified
- Sep 2023
- First submitted
- 26 Jun 2022
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Loring Z, Chelliah S, Selvester RH, Wagner G, Strauss DG. A detailed guide for quantification of myocardial scar with the Selvester QRS score in the presence of electrocardiogram confounders. J Electrocardiol. 2011 Sep-Oct;44(5):544-54. doi: 10.1016/j.jelectrocard.2011.06.008.
PubMed 21872001Sapra R, Hallqvist L, Schlegel TT, Ugander M, Bell M, Maanja M. Predicting peri-operative troponin elevation by advanced electrocardiography. J Electrocardiol. 2021 Sep-Oct;68:1-5. doi: 10.1016/j.jelectrocard.2021.06.008. Epub 2021 Jul 2.
PubMed 34246860
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of the Selvester QRS Score for Perioperative Myocardial Injury Following Non-cardiac Surgery
- ClinicalTrials.gov ID
- NCT05453097
- Acronym / sponsor ID
- 2022/172
- Keywords
- myocardial injury, Perioperative injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 11 Aug 2022 (actual)
- Primary completion
- 26 Sep 2023 (actual)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 12 Jul 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.
The purpose of this study to determine the prognostic value of the Selvester QRS score for perioperative myocardial injury following elective non-cardiac surgery.
Detailed description
This study was designed as an investigator-directed, non-commercial, observational, prospective, national, single-center study. The effect of preoperative complex ECG changes on the formation of cardiac damage will be studied. The data of the people participating in the study will be kept entirely confidential. After being informed about the study, all patients giving written informed consent will undergo preoperative evaluation. An ECG and cardiac troponin analysis will be performed to the patients who meet the eligibility. After the surgery will be completed control cardiac troponin and extensive physical examination will be performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perioperative Myocardial Injury Occured | – | Diagnostic Test: Selvester QRS Score with Preoperative ECGPatients with troponin elevation from the preoperative basal level do not meet the criteria for myocardial infarction according to the fourth universal myocardial infarction guideline, do not describe active anginal complaints, and underwent surgery in the operating room. |
| Perioperative Myocardial Injury Not Occured | – | Diagnostic Test: Selvester QRS Score with Preoperative ECGPatients without troponin elevation from the preoperative basal level, do not describe active anginal complaints, and underwent surgery in the operating room. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will be conducted on patients aged 18-90 years who have had elective surgery (besides cardiac operations) performed by a surgeon in the operating rooms of a tertiary university hospital, whose ECG before the operation is interpretable, and whose troponin value is measured before and after the operation.
Key inclusion criteria (6 listed)
- Patients who undergoing elective non-cardiac surgery in the operating room
- ≥18 years old
- Interpretable preoperative ECG of the patient
- Preoperative negative high sensitive Cardiac Troponin T
- ASA I-III class
Key exclusion criteria (7 listed)
- A history of myocardial infarction, coronary artery disease, PCI and revascularization
- A history of chronic renal disease, cerebrovascular incident, stroke
- ASA class IV
- Patients who do not give the informed consent
- Patients who undergoing emergency surgery
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 |
|---|---|---|
| Selvester QRS Score with Preoperative ECGSelvester QRS score will be calculated with the preoperative ECG of the patients. | Diagnostic test | Perioperative Myocardial Injury Not Occured, Perioperative Myocardial Injury Occured |
Primary outcome
The prediction of perioperative cardiac injury with preoperative Selvester ECG Score
Time frame: Change from Baseline cardiac troponin levels at postoperative 1st hour in PACU
Selvester ECG score is a validated technique for predicting myocardial scar and injury level in patients who undergone PCI. It is aimed to predict and demonstrate perioperative myocardial damage using this algorithm.
3 secondary outcomes
The prediction of preoperative high-sensitivity troponin and ECG abnormalities on arrhythmia susceptibility.
Time frame: Arrhythmia surveillance during peroperative and postoperative 1st hour in PACU
Effect of preoperative cardiac assessment on postoperative cardiac adverse event
Time frame: Cardiac adverse event surveillance during peroperative and postoperative 24 hours
Determination of postoperative intensive care hospitalizations for cardiac reasons
Time frame: postoperative intensive care hospitalizations for cardiac reasons until postoperative 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Results publication: PubMed 21872001Loring Z, Chelliah S, Selvester RH, Wagner G, Strauss DG. A detailed guide for quantification of myocardial scar with the Selvester QRS score in the presence of electrocardiogram confounders. J Electrocardiol. 2011 Sep-Oct;44(5):544-54. doi: 10.1016/j.jelectrocard.2011.06.008.
- Results publication: PubMed 34246860Sapra R, Hallqvist L, Schlegel TT, Ugander M, Bell M, Maanja M. Predicting peri-operative troponin elevation by advanced electrocardiography. J Electrocardiol. 2021 Sep-Oct;68:1-5. doi: 10.1016/j.jelectrocard.2021.06.008. Epub 2021 Jul 2.
- 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.
Kivanc Yalin, MD study chair
Istanbul University - Cerrahpasa
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 Cardiac Ischemia and Cardiac Arrhythmia, run by Istanbul University - Cerrahpasa 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 6 inclusion and 7 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 28 Sep 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?
Results are not available in the source record.
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?
The prediction of perioperative cardiac injury with preoperative Selvester ECG Score (time frame: Change from Baseline cardiac troponin levels at postoperative 1st hour in PACU). 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 NCT05453097, which also lists 2 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 28 Sep 2023.