Myocardial Injury and Postoperative Complications

NCT02150486 | Completed

• 1 other identifier: NL39172.100.11
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

To determine whether perioperative myocardial injury is associated with adverse outcome in patients scheduled for major abdominal surgery.

Conditions

Myocardial Injury

Outcome Measures

Primary Outcomes (1)

• Postoperative myocardial injury

  high sensitive troponin elevation at day 1, 3 or 7 after surgery

  7 days

Secondary Outcomes (1)

• Complication

  30-days

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for elective abdominal surgery at risk for coronary artery disease

You may qualify if:

• Patients \> 45 years of age with 1 or more major cardiovascular risk factors: Congestive heart failure, peripheral artery disease (intermittent claudication, history of vascular surgery etc), diabetes mellitus type I or II, coronary artery disease (history of myocardial infarction, stable angina pectoris, history of ischemia or coronary artery disease on cardiac tests (electrocardiogram, scintigraphy, echocardiogram, coronary angiogram etc), cerebrovascular accident, renal insufficiency (creatinine \> 150umol/l), aortic valve stenosis (valve area \< 1 cm2) OR 2 or more minor cardiovascular risk factors: Age \> 70, hypertension, high cholesterol, low functional capacity (4 metabolic equivalents or less), transient ischemic attack, chronic obstructive pulmonary disease AND undergoing abdominal surgery with an expected 30-day mortality rate \> 2-3%: colorectal, gastric, pancreatic and liver surgery.

You may not qualify if:

• Age \< 45 years of age, not scheduled for higher risk abdominal surgery, low cardiovascular risk profile.

Sponsors & Collaborators

• St. Antonius Hospital: lead

Study Sites (1)

St Antonius hospital

Nieuwegein, Utrecht, 3435 CM, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 22706835 BACKGROUND

• Noordzij PG, van Geffen O, Dijkstra IM, Boerma D, Meinders AJ, Rettig TC, Eefting FD, van Loon D, van de Garde EM, van Dongen EP. High-sensitive cardiac troponin T measurements in prediction of non-cardiac complications after major abdominal surgery. Br J Anaesth. 2015 Jun;114(6):909-18. doi: 10.1093/bja/aev027. Epub 2015 Mar 3.

  PMID: 25740400 DERIVED

Study Officials

• Peter Noordzij, MD

  St. Antonius Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: May 27, 2014
• First Posted: May 30, 2014
• Study Start: June 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: March 1, 2014
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

NL (1)