TREATROP: Myocardial Injury in Treatment of AAA

Sponsor

Göteborg University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04292652

Collaborator

Örebro University, Sweden (Other), Karlstad Central Hospital (Other)

Enrollment

Location

191

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Aortic Aneurysm, Abdominal Complication of Surgical Procedure Myocardium; Ischemic	Procedure: AAA surgery

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2007

Anticipated Primary Completion Date :

Apr 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
EVAR group Individuals undergoing endovascular aortic repair. n=40	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.
OR group Individuals undergoing open repair. n=40	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.

Arm

Intervention/Treatment

EVAR group

Individuals undergoing endovascular aortic repair. n=40

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.

OR group

Individuals undergoing open repair. n=40

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.

Outcome Measures

Primary Outcome Measures

Ischemic myocardial injury [Perioperative]
Perioperative myocardial injury induced by the procedure

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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