Clinical trial NCT04292652: Myocardial Injury in Treatment of AAA
Official title: Treatment With Endovascular or Open Repair for AAA - Comparison of Perioperative Myocardial Injury Detected With Holter-ECG and Troponin
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Aneurysm, Abdominal
Complication of Surgical Procedure
Myocardium; Ischemic
Keywords: AAA
Myocardial ischemic injury
Troponin
Holter-ECG
Vascular surgery
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Örebro University, Sweden
name: Karlstad Central Hospital
First posted: 2020-03-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive individuals accepted for either open or endovascular aortic repair in two Swedish hospitals

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.

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

Primary outcomes:
measure: Ischemic myocardial injury
timeFrame: Perioperative
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Gothenburg university
Study officials:
affiliation: Göteborg University
name: Per Skoog, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: