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NCT Number: NCT06536686

Silent Myocardial Ischemia in Patients Undergoing Non-oncological Abdominal Surgeries

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.

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Key information

Conditions

Silent Myocardial Ischemia Acute Coronary Syndrome Acute Myocardial Infarction Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with non-oncological abdominal disease and without cardiovascular disease
  • Patients with STEMI

Exclusion criteria

  • Patients with active cancer
  • Pregnant women
  • Psychiatric patients
  • Patient with dementia
  • Patients who do not understand basic instructions
  • Alcohol and illegal drug addicts

Treatment and study plan

Silent myocardial ischemia, STEMI

Genetic

Silent myocardial ischemia association with genetic polymorphisms, miRNA and EVs

Primary outcomes

  1. 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.

  2. 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

  3. Association with genetic polymorphisms

    Time frame: 1 month

    To investigate the association of folate pathway genetic polymorphisms with silent ischemia

  4. Association with miRNA

    Time frame: 1 month

    To investigate the role of miRNAs as biomarkers in silent ischemia

  5. Association with EVs

    Time frame: 1 month

    To investigate the role of EVs as biological markers in silent ischemia

  6. STEMI and biomarkers

    Time frame: 1 month

    To validate the presence of the candidate biomarkers in STEMI

Study contacts

Contact information is provided by the study sponsor or research team.

Jasna Klen, MD, PhD

CONTACT

[email protected]

0038631510916

Vita Dolzan, MD, PhD

CONTACT

[email protected]

0038651625455

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Collaborators

  • University of Ljubljana

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 5, 2024
Registry last updated
Aug 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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