Myocardial Injury in Treatment of AAA

NCT ID: NCT04292652

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-01-01
• Study Completion Date: 2025-12-01

Brief 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

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 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.

Conditions

Aortic Aneurysm, Abdominal; Complication of Surgical Procedure; Myocardium; Ischemic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

EVAR group

Individuals undergoing endovascular aortic repair. n=40

AAA surgery

Intervention Type: PROCEDURE

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.

OR group

Individuals undergoing open repair. n=40

AAA surgery

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Örebro University, Sweden

OTHER

Sponsor Role: collaborator

Karlstad Central Hospital

OTHER

Sponsor Role: collaborator

Göteborg University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Per Skoog, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Göteborg University

Locations

Gothenburg university

Gothenburg, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Ulf Nilsson, PhD

Role: CONTACT

ulf.nilsson@gu.se

+46317860000

Facility Contacts

Per Skoog, MD, PhD

Role: primary

per.skoog@vgregion.se

+467860000

Other Identifiers

GoteborgU 01-20

Identifier Type: -

Identifier Source: org_study_id