Silent Myocardial Ischemia in Patients Undergoing Non-oncological Abdominal Surgeries

NCT ID: NCT06536686

Last Updated: 2024-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-01

Study Completion Date

2025-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Silent Myocardial Ischemia Acute Myocardial Infarction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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The first group- silent myocardial ischemia

Silent myocardial ischemia, STEMI

Intervention Type GENETIC

Silent myocardial ischemia association with genetic polymorphisms, miRNA and EVs

The second group -STEMI undergoing primary coronary angiography.

Silent myocardial ischemia, STEMI

Intervention Type GENETIC

Silent myocardial ischemia association with genetic polymorphisms, miRNA and EVs

Interventions

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Silent myocardial ischemia, STEMI

Silent myocardial ischemia association with genetic polymorphisms, miRNA and EVs

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Ljubljana

OTHER

Sponsor Role collaborator

University Medical Centre Ljubljana

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jasna Klen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Centre Ljubljana

Locations

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UMC Ljubljana

Ljubljana, , Slovenia

Site Status RECRUITING

Countries

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Slovenia

Central Contacts

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Jasna Klen, MD, PhD

Role: CONTACT

0038631510916

Vita Dolzan, MD, PhD

Role: CONTACT

0038651625455

Facility Contacts

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Jasna Klen, MD, PhD

Role: primary

0038631510916

Vita Dolzan, MD,PhD

Role: backup

0038651625455

Other Identifiers

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7/2024

Identifier Type: -

Identifier Source: org_study_id

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