Silent Myocardial Ischemia in Patients Undergoing Non-oncological Abdominal Surgeries

July 30, 2024 updated by: University Medical Centre Ljubljana
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
The first group- silent myocardial ischemia
Genetic: Silent myocardial ischemia, STEMI
Silent myocardial ischemia association with genetic polymorphisms, miRNA and EVs
The second group -STEMI undergoing primary coronary angiography.
Genetic: Silent myocardial ischemia, STEMI
Silent myocardial ischemia association with genetic polymorphisms, miRNA and EVs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
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
12 months
Association with genetic polymorphisms
Time Frame: 1 month
To investigate the association of folate pathway genetic polymorphisms with silent ischemia
1 month
Association with miRNA
Time Frame: 1 month
To investigate the role of miRNAs as biomarkers in silent ischemia
1 month
Association with EVs
Time Frame: 1 month
To investigate the role of EVs as biological markers in silent ischemia
1 month
STEMI and biomarkers
Time Frame: 1 month
To validate the presence of the candidate biomarkers in STEMI
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Collaborators

University of Ljubljana

Investigators

  • Principal Investigator: Jasna Klen, MD, PhD, University Medical Centre Ljubljana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

July 24, 2024

First Submitted That Met QC Criteria

July 30, 2024

First Posted (Estimated)

August 5, 2024

Study Record Updates

Last Update Posted (Estimated)

August 5, 2024

Last Update Submitted That Met QC Criteria

July 30, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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