Myocardial Injury in Treatment of AAA

Aortic Aneurysm, Abdominal Clinical Trial

— TREATROP  

Official title:

Treatment With Endovascular or Open Repair for AAA - Comparison of Perioperative Myocardial Injury Detected With Holter-ECG and Troponin

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04292652
• Other study ID #: GoteborgU 01-20
• Status: Recruiting
• Start date: January 1, 2007
• Est. completion date: December 1, 2025

Study information

• Verified date: February 2024
• Source: Göteborg University
• Contact: Ulf Nilsson, PhD
• Phone: +46317860000
• Email: ulf.nilsson[@]gu.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Comparison of elective infrarenal aneurysm surgery with open and endovascular technique, respectively, for subclinical ischemic myocardial injury detectable with troponin T and/or 3-channel Holter ECG with ST analysis

Description:

Background: Traditional open surgery for abdominal aortic aneurysm (AAA) is burdened with complication risk from several organ systems, and also mortality figures of 3.5 - 5.5%. 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 90's 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 and/or 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 1, 2025
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Accepted for AAA surgery of either one of the operative techniques

Exclusion Criteria:

• High anesthesiological risk

• Preoperative cardiac condition with EF < 25 or ischemic signs on preoperative evaluation

• Severe renal insufficiency with s-creatinine >200

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Complication of Surgical Procedure
• Myocardial Ischemia
• Myocardium; Ischemic

Intervention

Procedure:
• AAA surgery
EVAR is a mini invasive procedure to exclude aortic aneurysms with the intention to prevent rupture. Open repair is the traditional open surgical procedure for the same condition.

Locations

Country	Name	City	State
Sweden	Gothenburg university	Gothenburg

Sponsors (3)

Lead Sponsor	Collaborator
Göteborg University	Karlstad Central Hospital, Örebro University, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ischemic myocardial injury	Perioperative myocardial injury induced by the procedure	Perioperative