Ignite Creation Date:
2024-05-06 @ 2:21 PM
Last Modification Date:
2024-10-26 @ 1:29 PM
Study NCT ID:
NCT04292652
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2020-02-28
Brief Title:
Myocardial Injury in Treatment of AAA
Sponsor:
Göteborg University
Organization:
Göteborg University
Study Overview
Official Title:
Treatment With Endovascular or Open Repair for AAA - Comparison of Perioperative Myocardial Injury Detected With Holter-ECG and Troponin
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TREATROP
Brief Summary:
Comparison of elective infrarenal aneurysm surgery with open and endovascular technique respectively for subclinical ischemic myocardial injury detectable with troponin T andor 3-channel Holter ECG with ST analysis
Detailed Description:
Background Traditional open surgery for abdominal aortic aneurysm AAA is burdened with complication risk from several organ systems and also mortality figures of 35 - 55 Over 50 of early mortality can be attributed to cardiovascular complications Myocardial infarction is the dominant organ-specific cause of both early and late mortality in patients operated on for AAA Endovascular surgery EndoVascular Aortic Repair EVAR was developed during the 90s as an alternative method that is considered less invasive and more well-tolerated from a cardiovascular perspective
Troponin T is a very sensitive and specific marker that predicts mortality in patients with acute symptoms of unstable angina andor heart attack Previous studies have also shown a high incidence of elevated troponin levels in patients who underwent major surgical procedures especially vascular surgery even in the absence of corresponding clinical or ECG-related symptoms of cardiac muscle injury Several studies have also demonstrated that elevated troponin levels after surgery predict increased morbidity and mortality both short-term and long-term
Objective To prospectively compare elective open and endovascular surgery of AAA with respect to myocardial injury detectable with troponin T Furthermore to compare open and endovascular AAA surgery for the total number of periods of oxygen deficiency in cardiac muscle during and at early stages after surgery using a special ECG method 48-hour 3-channel Holter ECG with ST analysis
Main aim of the study To assess whether EVAR induce less myocardial injury compared with open repair for AAA
Significance Myocardial infarction is the predominant cause of mortality in open surgical procedure for AAA In several previous studies troponin T rise has been associated with impaired both short-term and long-term prognosis in elderly patients undergoing major elective surgery This study may provide information on whether the endovascular technique provides a reduction in myocardial injury measured as elevated troponin T or myocardial ischemia with 3-channel Holter ECG In this way our study can provide improved decision support in the choice of the most appropriate treatment method in the individual case
Troponin T is a very sensitive and specific marker that predicts mortality in patients with acute symptoms of unstable angina andor heart attack Previous studies have also shown a high incidence of elevated troponin levels in patients who underwent major surgical procedures especially vascular surgery even in the absence of corresponding clinical or ECG-related symptoms of cardiac muscle injury Several studies have also demonstrated that elevated troponin levels after surgery predict increased morbidity and mortality both short-term and long-term
Objective To prospectively compare elective open and endovascular surgery of AAA with respect to myocardial injury detectable with troponin T Furthermore to compare open and endovascular AAA surgery for the total number of periods of oxygen deficiency in cardiac muscle during and at early stages after surgery using a special ECG method 48-hour 3-channel Holter ECG with ST analysis
Main aim of the study To assess whether EVAR induce less myocardial injury compared with open repair for AAA
Significance Myocardial infarction is the predominant cause of mortality in open surgical procedure for AAA In several previous studies troponin T rise has been associated with impaired both short-term and long-term prognosis in elderly patients undergoing major elective surgery This study may provide information on whether the endovascular technique provides a reduction in myocardial injury measured as elevated troponin T or myocardial ischemia with 3-channel Holter ECG In this way our study can provide improved decision support in the choice of the most appropriate treatment method in the individual case
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None