Myocardial Injury in Treatment of AAA (TREATROP)

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

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

Study Overview

• Status: Recruiting
• Conditions: Complication of Surgical Procedure; Aortic Aneurysm, Abdominal; Myocardium; Ischemic
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Ulf Nilsson, PhD; Phone Number: +46317860000; Email: ulf.nilsson@gu.se

Study Locations

• Sweden
  • Gothenburg, Sweden
    • Recruiting
    • Gothenburg university
    • Contact: Per Skoog, MD, PhD; Phone Number: +467860000; Email: per.skoog@vgregion.se
    • Principal Investigator: Per Skoog, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Consecutive individuals accepted for either open or endovascular aortic repair in two Swedish hospitals

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ischemic myocardial injury	Perioperative myocardial injury induced by the procedure	Perioperative

Collaborators and Investigators

• Sponsor: Göteborg University
• Collaborators: Örebro University, Sweden; Karlstad Central Hospital
• Investigators: Principal Investigator: Per Skoog, MD, PhD, Göteborg University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2007
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 28, 2020
• First Submitted That Met QC Criteria: February 28, 2020
• First Posted (Actual): March 3, 2020

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: AAA; Troponin; Myocardial ischemic injury; Holter-ECG; Vascular surgery
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Myocardial Ischemia; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: GoteborgU 01-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No