Silent Myocardial IschemiaNCT06536686
Silent Myocardial Ischemia in Patients Undergoing Non-oncological Abdominal Surgeries
An observational study of Silent Myocardial Ischemia and Acute Myocardial Infarction, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
Perioperative mortality in non-cardiac surgical procedures is 1-2 % with half of these cases attributed to cardiovascular events. Silent myocardial ischemia, which typically occurs within 72 hours to 30 days after surgery is the most common. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Silent Myocardial Ischemia, Acute Myocardial Infarction
- What is being tested?
- Silent myocardial ischemia, STEMI
- How many people
- 200 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Jul 2024to 1 Dec 2025
- How long will I take part?
- 12 Months
- 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: In the first group we will enroll 100 patients aged 18 and older without cardiovascular disease, which will undergo treatment for non-oncological abdominal procedures. Upon admission, they will complete a questionnaire regarding folate intake from food. We will follow all patients for 72 hours post-surgery and then for an additional 12 months , with telephone follow-ups every 3 months. We will record data on whether they experienced MACE during this period. Blood samples, such as troponin T and NT-proBNP, hsCRP, lipid profile, homocysteine, folic acid, and samples for biological markers, will be collected immediately upon admission. On the third day, blood will be collected for troponin T and NT-proBNP and biomarkers. In second group, we will recruit 100 patients with STEMI for PCI.
Who may be able to join
- Patients with non-oncological abdominal disease and without cardiovascular disease
- Patients with STEMI
Who cannot join
- Patients with active cancer
- Pregnant women
- Psychiatric patients
- Patient with dementia
- Patients who do not understand basic instructions
- Alcohol and illegal drug addicts
Trial locations and contacts
1 site in 1 country.
Slovenia1 site, 1 recruiting
- Recruiting
UMC Ljubljana
Ljubljana, 1000
Jasna Klen, MD, PhD, 0038631510916, jasna.klen@gmail.com
Vita Dolzan, MD,PhD, 0038651625455, vita.dolzan@mf.uni-lj.si
About this study
Perioperative mortality in non-cardiac surgical procedures is 1-2 % with half of these cases attributed to cardiovascular events. Silent myocardial ischemia, which typically occurs within 72 hours to 30 days after surgery is the most common. The only diagnostic criterion is troponin T, which should ideally be measured before the operation. In addition to troponin, blood samples can be taken for N terminal-pro BNP. Genetic factors can also contribute to the development of myocardial infarction. Methylenetetrahydrofolate reductase (MTHFR) is an important enzyme in homocysteine metabolism. The two most investigated variants of the MTHFR gene are C677T and A1298C single nucleotide polymorphisms (SNPs). As new biomarkers of cardiovascular diseases, non-coding RNAs, especially microRNAs (miRNAs) and circulating extracellular vesicles (EVs) are of interest. On the other hand, EVs were shown to reduce myocardial autophagy, leading to death during MI or ischemic-reperfusion injury. Methods: The investigators will enroll approximately 200 patients aged 18 and older. The first study of silent myocardial ischemia, will include patients without cardiovascular disease undergoing urgent or elective surgery for benign abdominal diseases. The second group will include patients with STEMI undergoing primary coronary angiography. Patients will also complete a questionnaire on folate intake. Subsequently, the investigators will collect blood for standard laboratory tests as well as troponin T, N terminal-pro BNP, homocysteine, and folic acid. Blood will be also collected for biomarker analysis. On the third day of hospitalization, blood will be collected again for troponin T, NT-proBNP and biomarkers. After that, the investigators will follow up the patients for another year every three months for the possible occurrence of major adverse cardiovascular events (MACE). Peripheral blood and blood from the coronary sinus will be collected in patients from the second study group for biomarker research. Expected results and significance for science and medicine: the investigators anticipate that the study will improve the understanding of clinical, biochemical, and biological markers of silent ischemia and cardiovascular complications following non-oncological abdominal surgeries. Knowledge of these factors would enable early identification of patients at higher risk of such complications, leading to more targeted preoperative preparation for non-oncological abdominal surgeries.
- Being tested
- Silent myocardial ischemia, STEMI
- Keywords
- acute coronary syndrome, silent myocardial ischemia, troponin T, NT-pro BNP, genetic polymorphisms, miRNA, extracellular vesicles
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silent myocardial ischemia, STEMIGenetic
Silent myocardial ischemia association with genetic polymorphisms, miRNA and EVs
| Study group | Role | What they receive |
|---|---|---|
| The first group- silent myocardial ischemia | Not described Receives: Genetic: Silent myocardial ischemia, STEMI | |
| The second group -STEMI undergoing primary coronary angiography. | Not described Receives: Genetic: Silent myocardial ischemia, STEMI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of silent ischemia
To investigate the incidence of silent ischemia in a group of patients hospitalized because of acute and chronic non-oncological abdominal surgery.
Measured: 12 months
Incidence of MACE
To investigate the incidence of major adverse cardiovascular events (MACE) within a one year from the discharge from the hospital
Measured: 12 months
Association with genetic polymorphisms
To investigate the association of folate pathway genetic polymorphisms with silent ischemia
Measured: 1 month
Association with miRNA
To investigate the role of miRNAs as biomarkers in silent ischemia
Measured: 1 month
Association with EVs
To investigate the role of EVs as biological markers in silent ischemia
Measured: 1 month
STEMI and biomarkers
To validate the presence of the candidate biomarkers in STEMI
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start1 Jul 2024
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Silent Myocardial IschemiaStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe 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
- 200 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ljubljana
- Responsible party
- Sponsor
- Investigators
- Jasna Klen, MD, PhD, Principal investigator, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06536686
- Sponsor's protocol ID
- 7/2024
- Status last verified
- Jul 2024
- First submitted
- 24 Jul 2024
- Last updated
- 5 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Silent Myocardial Ischemia in Patients Undergoing Non-oncological Abdominal Surgeries
- ClinicalTrials.gov ID
- NCT06536686
- Acronym / sponsor ID
- 7/2024
- Keywords
- acute coronary syndrome, silent myocardial ischemia, troponin T, NT-pro BNP, genetic polymorphisms, miRNA, extracellular vesicles
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Collaborators
- University of Ljubljana
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 5 Aug 2024 (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.
Perioperative mortality in non-cardiac surgical procedures is 1-2 % with half of these cases attributed to cardiovascular events. Silent myocardial ischemia, which typically occurs within 72 hours to 30 days after surgery is the most common. The only diagnostic criterion is troponin T, which should ideally be measured before the operation. In addition to troponin, blood samples can be taken for N terminal-pro BNP. Genetic factors can also contribute to the development of myocardial infarction. Methylenetetrahydrofolate reductase (MTHFR) is an important enzyme in homocysteine metabolism. The two most investigated variants of the MTHFR gene are C677T and A1298C single nucleotide polymorphisms (SNPs). As new biomarkers of cardiovascular diseases, non-coding RNAs, especially microRNAs (miRNAs) and circulating extracellular vesicles (EVs) are of interest. On the other hand, EVs were shown to reduce myocardial autophagy, leading to death during MI or ischemic-reperfusion injury. Methods: The investigators will enroll approximately 200 patients aged 18 and older. The first study of silent myocardial ischemia, will include patients without cardiovascular disease undergoing urgent or elective surgery for benign abdominal diseases. The second group will include patients with STEMI undergoing primary coronary angiography. Patients will also complete a questionnaire on folate intake. Subsequently, the investigators will collect blood for standard laboratory tests as well as troponin T, N terminal-pro BNP, homocysteine, and folic acid. Blood will be also collected for biomarker analysis. On the third day of hospitalization, blood will be collected again for troponin T, NT-proBNP and biomarkers. After that, the investigators will follow up the patients for another year every three months for the possible occurrence of major adverse cardiovascular events (MACE). Peripheral blood and blood from the coronary sinus will be collected in patients from the second study group for biomarker research. Expected results and significance for science and medicine: the investigators anticipate that the study will improve the understanding of clinical, biochemical, and biological markers of silent ischemia and cardiovascular complications following non-oncological abdominal surgeries. Knowledge of these factors would enable early identification of patients at higher risk of such complications, leading to more targeted preoperative preparation for non-oncological abdominal surgeries.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The first group- silent myocardial ischemia | – | Genetic: Silent myocardial ischemia, STEMI |
| The second group -STEMI undergoing primary coronary angiography. | – | Genetic: Silent myocardial ischemia, STEMI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In the first group we will enroll 100 patients aged 18 and older without cardiovascular disease, which will undergo treatment for non-oncological abdominal procedures. Upon admission, they will complete a questionnaire regarding folate intake from food. We will follow all patients for 72 hours post-surgery and then for an additional 12 months , with telephone follow-ups every 3 months. We will record data on whether they experienced MACE during this period. Blood samples, such as troponin T and NT-proBNP, hsCRP, lipid profile, homocysteine, folic acid, and samples for biological markers, will be collected immediately upon admission. On the third day, blood will be collected for troponin T and NT-proBNP and biomarkers. In second group, we will recruit 100 patients with STEMI for PCI.
Key inclusion criteria (2 listed)
- Patients with non-oncological abdominal disease and without cardiovascular disease
- Patients with STEMI
Key exclusion criteria (6 listed)
- Patients with active cancer
- Pregnant women
- Psychiatric patients
- Patient with dementia
- Patients who do not understand basic instructions
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 |
|---|---|---|
| Silent myocardial ischemia, STEMISilent myocardial ischemia association with genetic polymorphisms, miRNA and EVs | Genetic | The first group- silent myocardial ischemia, The second group -STEMI undergoing primary coronary angiography. |
Primary outcome
Incidence of silent ischemia
Time frame: 12 months
To investigate the incidence of silent ischemia in a group of patients hospitalized because of acute and chronic non-oncological abdominal surgery.
Incidence of MACE
Time frame: 12 months
To investigate the incidence of major adverse cardiovascular events (MACE) within a one year from the discharge from the hospital
Association with genetic polymorphisms
Time frame: 1 month
To investigate the association of folate pathway genetic polymorphisms with silent ischemia
Association with miRNA
Time frame: 1 month
To investigate the role of miRNAs as biomarkers in silent ischemia
Association with EVs
Time frame: 1 month
To investigate the role of EVs as biological markers in silent ischemia
STEMI and biomarkers
Time frame: 1 month
To validate the presence of the candidate biomarkers in STEMI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- 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.
Jasna Klen, MD, PhD principal investigator
University Medical Centre Ljubljana
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 Silent Myocardial Ischemia and Acute Myocardial Infarction, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 6 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 5 Aug 2024. 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 Slovenia. 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 Jasna Klen, MD, PhD (0038631510916, jasna.klen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of silent ischemia (time frame: 12 months). The study lists 6 primary outcomes in all. 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 5 Aug 2024.