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临床试验/NCT06536686
NCT06536686招募中不适用

Silent Myocardial Ischemia in Patients Undergoing Non-oncological Abdominal Surgeries

University Medical Centre Ljubljana1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Association with miRNA

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Association with miRNA

时间窗: 1 month

To investigate the role of miRNAs as biomarkers in silent ischemia

Incidence of MACE

时间窗: 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

时间窗: 1 month

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

Association with EVs

时间窗: 1 month

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

Incidence of silent ischemia

时间窗: 12 months

To investigate the incidence of silent ischemia in a group of patients hospitalized because of acute and chronic non-oncological abdominal surgery.

STEMI and biomarkers

时间窗: 1 month

To validate the presence of the candidate biomarkers in STEMI

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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