Aortic Aneurysm, AbdominalTREATROPNCT04292652
Myocardial Injury in Treatment of AAA
An observational study of Aortic Aneurysm, Abdominal and Complication of Surgical Procedure, run by Göteborg University at 1 site in Sweden.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm, Abdominal, Complication of Surgical Procedure, Myocardium; Ischemic
- What is being tested?
- AAA surgery
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2007to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive individuals accepted for either open or endovascular aortic repair in two Swedish hospitals
Who may be able to join
- Accepted for AAA surgery of either one of the operative techniques
Who cannot join
- High anesthesiological risk
- Preoperative cardiac condition with EF < 25 or ischemic signs on preoperative evaluation
- Severe renal insufficiency with s-creatinine >200
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Gothenburg university
Gothenburg
Per Skoog, MD, PhD, +467860000, per.skoog@vgregion.se
Per Skoog, MD, PhD
About this study
Official title: 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
Read the 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.
- Being tested
- AAA surgery
- Keywords
- AAA, Myocardial ischemic injury, Troponin, Holter-ECG, Vascular surgery
- Medical subject headings
- Aortic Aneurysm, Abdominal, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AAA surgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| EVAR group | Individuals undergoing endovascular aortic repair. n=40 Receives: Procedure: AAA surgery | |
| OR group | Individuals undergoing open repair. n=40 Receives: Procedure: AAA surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ischemic myocardial injury
Perioperative myocardial injury induced by the procedure
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start1 Jan 2007
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Aneurysm, AbdominalStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Örebro University, Sweden, Karlstad Central Hospital
- Responsible party
- Sponsor
- Investigators
- Per Skoog, MD, PhD, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292652
- Sponsor's protocol ID
- GoteborgU 01-20
- Acronym
- TREATROP
- Status last verified
- Feb 2024
- First submitted
- 28 Feb 2020
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment With Endovascular or Open Repair for AAA - Comparison of Perioperative Myocardial Injury Detected With Holter-ECG and Troponin
- ClinicalTrials.gov ID
- NCT04292652
- Acronym / sponsor ID
- TREATROP / GoteborgU 01-20
- Keywords
- AAA, Myocardial ischemic injury, Troponin, Holter-ECG, Vascular surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Örebro University, Sweden, Karlstad Central Hospital
- Study start
- 1 Jan 2007 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 3 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EVAR group | – | Procedure: AAA surgeryIndividuals undergoing endovascular aortic repair. n=40 |
| OR group | – | Procedure: AAA surgeryIndividuals undergoing open repair. n=40 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive individuals accepted for either open or endovascular aortic repair in two Swedish hospitals
Key inclusion criteria (1 listed)
- Accepted for AAA surgery of either one of the operative techniques
Key exclusion criteria (3 listed)
- High anesthesiological risk
- Preoperative cardiac condition with EF < 25 or ischemic signs on preoperative evaluation
- Severe renal insufficiency with s-creatinine >200
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AAA surgeryEVAR 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. | Procedure or surgery | EVAR group, OR group |
Primary outcome
Ischemic myocardial injury
Time frame: Perioperative
Perioperative myocardial injury induced by the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Skoog, MD, PhD principal investigator
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Aneurysm, Abdominal and Complication of Surgical Procedure, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ulf Nilsson, PhD (+46317860000, ulf.nilsson@gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ischemic myocardial injury (time frame: Perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.