Left-Sided Heart FailureNCT04836702
Echocardiography as Risk-Assessment for Major Adverse Cardiac Events in Major Vascular Surgery Patients
An observational study of Left-Sided Heart Failure and Right-Sided Heart Failure, run by University of Virginia.
Trial summary
Patient with coronary artery disease (CAD), heart failure and abnormal heart function undergoing major vascular surgery have a high associated high morbidity and mortality with myocardial infarction accounting for 33-50% of perioperative deaths. The prevalence of CAD in vascular surgery patients approaches 50%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left-Sided Heart Failure, Right-Sided Heart Failure, Heart Valve Diseases
- How many people
- 813 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2011to 21 Mar 2022
- 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
- Adult, Older adult
Study population: Patients who underwent major vascular surgery operations at the University of Virginia
Who may be able to join
- Major vascular surgery operation (e.g. CEA, open aortic repair, suprainguinal and infrainguinal bypasses, EVAR, TEVAR) captured in the UVA Vascular Quality Initiative database
- Echocardiography within two years of index operation
Who cannot join
- If patient had additional qualifying vascular procedure within 30 days of the index operation, this procedure was excluded
About this study
Official title: Vascular Surgery Outcomes: Echocardiography as Risk-Assessment for Major Adverse Cardiac Events in Major Vascular Surgery Patients
Patient with coronary artery disease (CAD), heart failure and abnormal heart function undergoing major vascular surgery have a high associated high morbidity and mortality with myocardial infarction accounting for 33-50% of perioperative deaths. The prevalence of CAD in vascular surgery patients approaches 50%. Proper pre-procedure protocols to accurately assess patients and determine who may require further medical optimization prior to undergoing surgery help mitigate risk and improve outcomes. The investigators designed this study as a single center, retrospective cohort analysis to explore the association between ventricular (LV and RV function) and valvular (Aortic / Mitral / Tricuspid) function and expanded major adverse cardiac events (X-MACE).
- Keywords
- major vascular surgery, major adverse cardiac events
- Medical subject headings
- Heart Failure, Heart Valve Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Left ventricular function | * Depressed LV function 1. LV ejection fraction < 50% 2. LV systolic function; defined as mild / mod / sev decreased 3. LV diastolic function; defined as mild (g1 ) / mod (g2) / sev ( g3) decreased * Normal LV function | |
| Right ventricular function | * Depressed RV function a. RV systolic function defined as mild / mod / sev decreased * Normal RV function | |
| Valvular lesions | * Moderate or severe valvular lesions 1. Aortic stenosis 2. Aortic regurgitation 3. Mitral stenosis 4. Mitral regurgitation 5. Tricuspid regurgitation * Clinically normal valvular lesions 1. No valvular lesion 2. Mild stenosis / regurgitation of above mentioned lesions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expanded Major Adverse Cardiac Events
Composite outcome defined as any cardiovascular death, non-fatal MI, non-fatal stroke, post-operative CHF, or new dysrhythmias, all within the index hospital admission.
Measured: In-hospital admission (within 120 days of index surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 Jan 2011
- Primary completion23 Jun 2020
- Study completion21 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Left-Sided Heart FailureStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Retrospective
- Enrolment
- 813 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margaret Clarke Tracci, University of Virginia
- Investigators
- Matthew Meyer, MD, Study director, Assistant Professor of Anesthesiology at University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04836702
- Sponsor's protocol ID
- 20906
- Status last verified
- Jun 2024
- First submitted
- 1 Apr 2021
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Will be made on an individual basis in accordance with guidance from the IRB and VQI panel
Publications
Reis PV, Lopes AI, Leite D, Moreira J, Mendes L, Ferraz S, Amaral T, Mourao J, Abelha F. Major Cardiac Events in Patients Admitted to Intensive Care After Vascular Noncardiac Surgery: A Retrospective Cohort. Semin Cardiothorac Vasc Anesth. 2019 Sep;23(3):293-299. doi: 10.1177/1089253218825442. Epub 2019 Jan 25.
PubMed 30678531Golubovic M, Peric V, Stanojevic D, Lazarevic M, Jovanovic N, Ilic N, Djordjevic M, Kostic T, Milic D. Potential New Approaches in Predicting Adverse Cardiac Events One Month after Major Vascular Surgery. Med Princ Pract. 2019;28(1):63-69. doi: 10.1159/000495079. Epub 2018 Nov 4.
PubMed 30391950Ouriel K, Green RM, DeWeese JA, Varon ME. Outpatient echocardiography as a predictor of perioperative cardiac morbidity after peripheral vascular surgical procedures. J Vasc Surg. 1995 Dec;22(6):671-7; discussion 678-9. doi: 10.1016/s0741-5214(95)70057-9.
PubMed 8523601Flu WJ, van Kuijk JP, Hoeks SE, Kuiper R, Schouten O, Goei D, Elhendy A, Verhagen HJ, Thomson IR, Bax JJ, Fleisher LA, Poldermans D. Prognostic implications of asymptomatic left ventricular dysfunction in patients undergoing vascular surgery. Anesthesiology. 2010 Jun;112(6):1316-24. doi: 10.1097/ALN.0b013e3181da89ca.
PubMed 20502115Lerman BJ, Popat RA, Assimes TL, Heidenreich PA, Wren SM. Association of Left Ventricular Ejection Fraction and Symptoms With Mortality After Elective Noncardiac Surgery Among Patients With Heart Failure. JAMA. 2019 Feb 12;321(6):572-579. doi: 10.1001/jama.2019.0156.
PubMed 30747965Matyal R, Hess PE, Subramaniam B, Mitchell J, Panzica PJ, Pomposelli F, Mahmood F. Perioperative diastolic dysfunction during vascular surgery and its association with postoperative outcome. J Vasc Surg. 2009 Jul;50(1):70-6. doi: 10.1016/j.jvs.2008.12.032.
PubMed 19563954Meyer MJ, Jameson SA, Gillig EJ, Aggarwal A, Ratcliffe SJ, Baldwin M, Singh KE, Clouse WD, Blank RS. Clinical implications of preoperative echocardiographic findings on cardiovascular outcomes following vascular surgery: An observational trial. PLoS One. 2023 Jan 19;18(1):e0280531. doi: 10.1371/journal.pone.0280531. eCollection 2023.
PubMed 36656845
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Surgery Outcomes: Echocardiography as Risk-Assessment for Major Adverse Cardiac Events in Major Vascular Surgery Patients
- ClinicalTrials.gov ID
- NCT04836702
- Acronym / sponsor ID
- 20906
- Keywords
- major vascular surgery, major adverse cardiac events
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 813 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 23 Jun 2020 (actual)
- Study completion
- 21 Mar 2022 (actual)
- First posted
- 8 Apr 2021 (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.
Patient with coronary artery disease (CAD), heart failure and abnormal heart function undergoing major vascular surgery have a high associated high morbidity and mortality with myocardial infarction accounting for 33-50% of perioperative deaths. The prevalence of CAD in vascular surgery patients approaches 50%. Proper pre-procedure protocols to accurately assess patients and determine who may require further medical optimization prior to undergoing surgery help mitigate risk and improve outcomes. The investigators designed this study as a single center, retrospective cohort analysis to explore the association between ventricular (LV and RV function) and valvular (Aortic / Mitral / Tricuspid) function and expanded major adverse cardiac events (X-MACE).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Left ventricular function | – | –* Depressed LV function 1. LV ejection fraction < 50% 2. LV systolic function; defined as mild / mod / sev decreased 3. LV diastolic function; defined as mild (g1 ) / mod (g2) / sev ( g3) decreased * Normal LV function |
| Right ventricular function | – | –* Depressed RV function a. RV systolic function defined as mild / mod / sev decreased * Normal RV function |
| Valvular lesions | – | –* Moderate or severe valvular lesions 1. Aortic stenosis 2. Aortic regurgitation 3. Mitral stenosis 4. Mitral regurgitation 5. Tricuspid regurgitation * Clinically normal valvular lesions 1. No valvular lesion 2. Mild stenosis / regurgitation of above mentioned lesions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent major vascular surgery operations at the University of Virginia
Key inclusion criteria (2 listed)
- Major vascular surgery operation (e.g. CEA, open aortic repair, suprainguinal and infrainguinal bypasses, EVAR, TEVAR) captured in the UVA Vascular Quality Initiative database
- Echocardiography within two years of index operation
Key exclusion criteria (1 listed)
- If patient had additional qualifying vascular procedure within 30 days of the index operation, this procedure was excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Expanded Major Adverse Cardiac Events
Time frame: In-hospital admission (within 120 days of index surgery)
Composite outcome defined as any cardiovascular death, non-fatal MI, non-fatal stroke, post-operative CHF, or new dysrhythmias, all within the index hospital admission.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Background: PubMed 30678531Reis PV, Lopes AI, Leite D, Moreira J, Mendes L, Ferraz S, Amaral T, Mourao J, Abelha F. Major Cardiac Events in Patients Admitted to Intensive Care After Vascular Noncardiac Surgery: A Retrospective Cohort. Semin Cardiothorac Vasc Anesth. 2019 Sep;23(3):293-299. doi: 10.1177/1089253218825442. Epub 2019 Jan 25.
- Background: PubMed 30391950Golubovic M, Peric V, Stanojevic D, Lazarevic M, Jovanovic N, Ilic N, Djordjevic M, Kostic T, Milic D. Potential New Approaches in Predicting Adverse Cardiac Events One Month after Major Vascular Surgery. Med Princ Pract. 2019;28(1):63-69. doi: 10.1159/000495079. Epub 2018 Nov 4.
- Background: PubMed 8523601Ouriel K, Green RM, DeWeese JA, Varon ME. Outpatient echocardiography as a predictor of perioperative cardiac morbidity after peripheral vascular surgical procedures. J Vasc Surg. 1995 Dec;22(6):671-7; discussion 678-9. doi: 10.1016/s0741-5214(95)70057-9.
- Background: PubMed 20502115Flu WJ, van Kuijk JP, Hoeks SE, Kuiper R, Schouten O, Goei D, Elhendy A, Verhagen HJ, Thomson IR, Bax JJ, Fleisher LA, Poldermans D. Prognostic implications of asymptomatic left ventricular dysfunction in patients undergoing vascular surgery. Anesthesiology. 2010 Jun;112(6):1316-24. doi: 10.1097/ALN.0b013e3181da89ca.
- Background: PubMed 30747965Lerman BJ, Popat RA, Assimes TL, Heidenreich PA, Wren SM. Association of Left Ventricular Ejection Fraction and Symptoms With Mortality After Elective Noncardiac Surgery Among Patients With Heart Failure. JAMA. 2019 Feb 12;321(6):572-579. doi: 10.1001/jama.2019.0156.
- Background: PubMed 19563954Matyal R, Hess PE, Subramaniam B, Mitchell J, Panzica PJ, Pomposelli F, Mahmood F. Perioperative diastolic dysfunction during vascular surgery and its association with postoperative outcome. J Vasc Surg. 2009 Jul;50(1):70-6. doi: 10.1016/j.jvs.2008.12.032.
- Derived from this study: PubMed 36656845Meyer MJ, Jameson SA, Gillig EJ, Aggarwal A, Ratcliffe SJ, Baldwin M, Singh KE, Clouse WD, Blank RS. Clinical implications of preoperative echocardiographic findings on cardiovascular outcomes following vascular surgery: An observational trial. PLoS One. 2023 Jan 19;18(1):e0280531. doi: 10.1371/journal.pone.0280531. eCollection 2023.
- Individual participant dataSharing planned: Undecided. Will be made on an individual basis in accordance with guidance from the IRB and VQI panel
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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.
Matthew Meyer, MD study director
Assistant Professor of Anesthesiology at University of Virginia
Questions about this trial
What is this clinical trial studying?
An observational study of Left-Sided Heart Failure and Right-Sided Heart Failure, run by University of Virginia.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expanded Major Adverse Cardiac Events (time frame: In-hospital admission (within 120 days of index surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04836702, which also lists 7 linked publications.
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 14 Jun 2024.