NCT04292652

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
13.2 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 3, 2020

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

17.3 years

First QC Date

February 28, 2020

Last Update Submit

February 26, 2024

Conditions

Aortic Aneurysm, AbdominalComplication of Surgical ProcedureMyocardium; Ischemic

Keywords

AAAMyocardial ischemic injuryTroponinHolter-ECGVascular surgery

Outcome Measures

Primary Outcomes (1)

  • Ischemic myocardial injury

    Perioperative myocardial injury induced by the procedure

    Perioperative

Study Arms (2)

EVAR group

Individuals undergoing endovascular aortic repair. n=40

Procedure: AAA surgery

OR group

Individuals undergoing open repair. n=40

Procedure: AAA surgery

Interventions

AAA surgeryPROCEDURE

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.

EVAR groupOR group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • High anesthesiological risk
  • Preoperative cardiac condition with EF \< 25 or ischemic signs on preoperative evaluation
  • Severe renal insufficiency with s-creatinine \>200

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gothenburg university

Gothenburg, Sweden

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm, AbdominalCoronary Artery Disease

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Per Skoog, MD, PhD

    Göteborg University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ulf Nilsson, PhD

CONTACT

+46317860000ulf.nilsson@gu.se

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2020

First Posted

March 3, 2020

Study Start

January 1, 2007

Primary Completion

April 1, 2024

Study Completion

December 1, 2025

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)