AzTrials
AzTrials

Mortality After Major Non Cardiac SurgeryISTMONCT03365726

Intraoperative Dobutamine Stress Test With Speckle Tracking to Decrease Postoperative Mortality (ISTMO)

A study testing Dobutamine stress test with trans-esophageal echocardiography in people with Mortality After Major Non Cardiac Surgery, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Perioperative adverse cardiovascular events are the leading cause of morbidity and mortality after noncardiac surgery. The implications of perioperative cardiac complications on morbidity and mortality, in-hospital and long-term care, and resource utilization are enormous. Read more about this study

Who is it for?
Ages 50 to 80 yearsHealthy volunteers can take part
What is being tested?
Dobutamine stress test with trans-esophageal echocardiography
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteCanada
Study dates
19 Jan 2016to 19 Jan 2021
Phase
Interventional
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 50 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Any laparotomy
  • Any thoracotomy
  • Any hip surgery
  • Any complex oncologic surgery o Any thoracoscopy

Who cannot join

  • Females older than 80 year old
  • Patients on chronic systemic corticosteroid therapy
  • Diagnosed pharyngeal or gastro-esophageal pathologies (such as esophageal varices, stricture, diverticula, tumor, esophagitis, Mallory- Weiss tear, or previous surgery for any of these)
  • Signs and symptoms of severe pharyngeal or gastro-esophageal pathologies (including odynophagia, dysphagia)
  • Emergency surgery
  • Age less than 50 year old

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • MUHC

    Montreal, Quebec

Other trials in Canada

About this study

Official title: Intraoperative Stress Test With Dobutamine and Speckle Tracking to Decrease Postoperative Mortality

Perioperative adverse cardiovascular events are the leading cause of morbidity and mortality after noncardiac surgery. The implications of perioperative cardiac complications on morbidity and mortality, in-hospital and long-term care, and resource utilization are enormous. The continuously increasing proportion of elderly patients presenting for noncardiac surgery raises serious concerns regarding adverse cardiac events in the perioperative period. The responsibility for early diagnosis and prompt treatment of cardiac complications during surgery rests squarely with the anesthesiologist. Reliable intraoperative identification of patients at high risk for postoperative AMI and/or death is currently inadequate, but may confer substantial benefits to patients as preventive measures could be instituted. A reliable and reproducible quantitative measure of regional and global myocardial function could improve preoperative risk stratification and guide anesthetic management when acute changes in myocardial function occur.

In the present study is hypothesized that intraoperative dobutamine stress echocardiography by 2-dimensional speckle tracking echocardiography can identify patients at higher risk of perioperative adverse cardiac events.

Read the detailed description

Due to changes in study execution, analyses focused on prospectively collected physiological data examining myocardial contractile reserve and its association with postoperative myocardial injury

Being tested
Dobutamine stress test with trans-esophageal echocardiography

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dobutamine stress test with trans-esophageal echocardiographyDiagnostic test

    Dobutamine stress echocardiography will be performed: before skin incision and at the end of surgery.

    After a TEE evaluation at rest to assess myocardial structure, function and potential regional wall motion abnormalities, dobutamine infusion will be started

    • If no regional wall motion abnormalities will be detected, a dobutamine stress echocardiography will be started at the range infusion of 50 γ/kg/min (ADST: Accelerated Dobutamine Stress Test). The Test will be continued up to the 85% of maximum heart rate adjusted for the patient age and echo images will be stored.
    • If regional wall motion abnormalities are present, a gradual dobutamine stress test will be started at the initial dose of 10 mcg/kg/min (GDST: Gradual Dobutamine Stress Test) and it will be increased every 3 minutes until the 85% of maximum heart rate, adjusted for patient's age (maximal dose: 40 mcg/kg/min) and echo images will be stored.
Study groups in NCT03365726
Study groupRoleWhat they receive
DST (dobutamine-stress-test)Experimentaldobutamine stress echocardiography performed to patients undergoing major surgery
Receives: Diagnostic Test: Dobutamine stress test with trans-esophageal echocardiography
NDST (no-dobutamine-stress-test)No interventionpatients refused the dobutamine stress test and transesophageal echocardiography measured the troponin level in first 24 hours after surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. mortality

    mortality

    Measured: 30 days

Secondary outcomes (1)
  1. myocardial infarction

    new ECG changes with troponin increase

    Measured: within 30 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2017
  2. Study start19 Jan 2016
  3. Primary completion19 Jan 2018
  4. Study completion19 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03365726
Sponsor's protocol ID
15-228-MUHC
Acronym
ISTMO
Status last verified
May 2026
First submitted
22 Nov 2017
Last updated
11 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Vascular Events In Noncardiac Surgery Patients Cohort Evaluation (VISION) Study Investigators; Devereaux PJ, Chan MT, Alonso-Coello P, Walsh M, Berwanger O, Villar JC, Wang CY, Garutti RI, Jacka MJ, Sigamani A, Srinathan S, Biccard BM, Chow CK, Abraham V, Tiboni M, Pettit S, Szczeklik W, Lurati Buse G, Botto F, Guyatt G, Heels-Ansdell D, Sessler DI, Thorlund K, Garg AX, Mrkobrada M, Thomas S, Rodseth RN, Pearse RM, Thabane L, McQueen MJ, VanHelder T, Bhandari M, Bosch J, Kurz A, Polanczyk C, Malaga G, Nagele P, Le Manach Y, Leuwer M, Yusuf S. Association between postoperative troponin levels and 30-day mortality among patients undergoing noncardiac surgery. JAMA. 2012 Jun 6;307(21):2295-304. doi: 10.1001/jama.2012.5502.

    PubMed 22706835
  • Devereaux PJ, Xavier D, Pogue J, Guyatt G, Sigamani A, Garutti I, Leslie K, Rao-Melacini P, Chrolavicius S, Yang H, Macdonald C, Avezum A, Lanthier L, Hu W, Yusuf S; POISE (PeriOperative ISchemic Evaluation) Investigators. Characteristics and short-term prognosis of perioperative myocardial infarction in patients undergoing noncardiac surgery: a cohort study. Ann Intern Med. 2011 Apr 19;154(8):523-8. doi: 10.7326/0003-4819-154-8-201104190-00003.

    PubMed 21502650
  • Landesberg G, Beattie WS, Mosseri M, Jaffe AS, Alpert JS. Perioperative myocardial infarction. Circulation. 2009 Jun 9;119(22):2936-44. doi: 10.1161/CIRCULATIONAHA.108.828228. No abstract available.

    PubMed 19506125
  • Pearse RM, Moreno RP, Bauer P, Pelosi P, Metnitz P, Spies C, Vallet B, Vincent JL, Hoeft A, Rhodes A; European Surgical Outcomes Study (EuSOS) group for the Trials groups of the European Society of Intensive Care Medicine and the European Society of Anaesthesiology. Mortality after surgery in Europe: a 7 day cohort study. Lancet. 2012 Sep 22;380(9847):1059-65. doi: 10.1016/S0140-6736(12)61148-9.

    PubMed 22998715
  • Rose J, Weiser TG, Hider P, Wilson L, Gruen RL, Bickler SW. Estimated need for surgery worldwide based on prevalence of diseases: a modelling strategy for the WHO Global Health Estimate. Lancet Glob Health. 2015 Apr 27;3 Suppl 2(Suppl 2):S13-20. doi: 10.1016/S2214-109X(15)70087-2.

    PubMed 25926315
  • Weiser TG, Regenbogen SE, Thompson KD, Haynes AB, Lipsitz SR, Berry WR, Gawande AA. An estimation of the global volume of surgery: a modelling strategy based on available data. Lancet. 2008 Jul 12;372(9633):139-144. doi: 10.1016/S0140-6736(08)60878-8. Epub 2008 Jun 24.

    PubMed 18582931
  • Garutti I, Paniagua P, Cruz P, Maestre ML, Fernandez-Riveira C, Alonso-Coello P; Spanish VISION Investigators. Analytic comments of the initial results of the VISION (Vascular events In noncardiac Surgery patIents cOhort evaluatioN): Association between troponin T and mortality at 30 days in noncardiac surgery patients. Rev Esp Anestesiol Reanim. 2013 Jun-Jul;60(6):304-7. doi: 10.1016/j.redar.2012.10.015. Epub 2012 Dec 20. No abstract available.

    PubMed 23261223
  • Hoffmann R, Marwick TH, Poldermans D, Lethen H, Ciani R, van der Meer P, Tries HP, Gianfagna P, Fioretti P, Bax JJ, Katz MA, Erbel R, Hanrath P. Refinements in stress echocardiographic techniques improve inter-institutional agreement in interpretation of dobutamine stress echocardiograms. Eur Heart J. 2002 May;23(10):821-9. doi: 10.1053/euhj.2001.2968.

    PubMed 12009723
  • Moonen M, Lancellotti P, Zacharakis D, Pierard L. The value of 2D strain imaging during stress testing. Echocardiography. 2009 Mar;26(3):307-14. doi: 10.1111/j.1540-8175.2008.00864.x.

    PubMed 19291016
  • Amundsen BH, Helle-Valle T, Edvardsen T, Torp H, Crosby J, Lyseggen E, Stoylen A, Ihlen H, Lima JA, Smiseth OA, Slordahl SA. Noninvasive myocardial strain measurement by speckle tracking echocardiography: validation against sonomicrometry and tagged magnetic resonance imaging. J Am Coll Cardiol. 2006 Feb 21;47(4):789-93. doi: 10.1016/j.jacc.2005.10.040. Epub 2006 Jan 26.

    PubMed 16487846
  • Cho GY, Chan J, Leano R, Strudwick M, Marwick TH. Comparison of two-dimensional speckle and tissue velocity based strain and validation with harmonic phase magnetic resonance imaging. Am J Cardiol. 2006 Jun 1;97(11):1661-6. doi: 10.1016/j.amjcard.2005.12.063. Epub 2006 Apr 19.

    PubMed 16728234
  • Aggeli C, Lagoudakou S, Felekos I, Panagopoulou V, Kastellanos S, Toutouzas K, Roussakis G, Tousoulis D. Two-dimensional speckle tracking for the assessment of coronary artery disease during dobutamine stress echo: clinical tool or merely research method. Cardiovasc Ultrasound. 2015 Oct 24;13:43. doi: 10.1186/s12947-015-0038-z.

    PubMed 26498476
  • Reant P, Labrousse L, Lafitte S, Bordachar P, Pillois X, Tariosse L, Bonoron-Adele S, Padois P, Deville C, Roudaut R, Dos Santos P. Experimental validation of circumferential, longitudinal, and radial 2-dimensional strain during dobutamine stress echocardiography in ischemic conditions. J Am Coll Cardiol. 2008 Jan 15;51(2):149-57. doi: 10.1016/j.jacc.2007.07.088.

    PubMed 18191740
  • Yu Y, Villarraga HR, Saleh HK, Cha SS, Pellikka PA. Can ischemia and dyssynchrony be detected during early stages of dobutamine stress echocardiography by 2-dimensional speckle tracking echocardiography? Int J Cardiovasc Imaging. 2013 Jan;29(1):95-102. doi: 10.1007/s10554-012-0074-9. Epub 2012 May 25.

    PubMed 22628053
  • Pellikka PA, Nagueh SF, Elhendy AA, Kuehl CA, Sawada SG; American Society of Echocardiography. American Society of Echocardiography recommendations for performance, interpretation, and application of stress echocardiography. J Am Soc Echocardiogr. 2007 Sep;20(9):1021-41. doi: 10.1016/j.echo.2007.07.003. No abstract available.

    PubMed 17765820

Questions about this trial

What is this clinical trial studying?

A study testing Dobutamine stress test with trans-esophageal echocardiography in people with Mortality After Major Non Cardiac Surgery, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

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 4 inclusion and 6 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 11 May 2026. 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 Canada. 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?

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?

mortality (time frame: 30 days). 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 NCT03365726, which also lists 17 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 11 May 2026.

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