Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06536686
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
Silent Myocardial Ischemia in Patients Undergoing Non-oncological Abdominal Surgeries
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Silent Myocardial Ischemia in Patients Undergoing Non-oncological Abdominal Surgeries
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None