Actively Recruiting
Silent Myocardial Ischemia in Patients Undergoing Non-oncological Abdominal Surgeries
Led by University Medical Centre Ljubljana · Updated on 2024-08-05
200
Participants Needed
1
Research Sites
74 weeks
Total Duration
On this page
Sponsors
U
University Medical Centre Ljubljana
Lead Sponsor
U
University of Ljubljana
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Silent Myocardial Ischemia in Patients Undergoing Non-oncological Abdominal Surgeries
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with non-oncological abdominal disease and without cardiovascular disease
- Patients with STEMI
You will not qualify if you...
- Patients with active cancer
- Pregnant women
- Psychiatric patients
- Patients with dementia
- Patients who do not understand basic instructions
- Alcohol and illegal drug addicts
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UMC Ljubljana
Ljubljana, Slovenia, 1000
Actively Recruiting
Research Team
J
Jasna Klen, MD, PhD
CONTACT
V
Vita Dolzan, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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