NCT00928460

Brief Summary

A preoperative electrocardiogram (ECG) is nearly routinely performed by anesthesiologists in elderly non-cardiac surgery patients as part of pre-anesthesia evaluation. However, the added value of this routine ECG beyond patient history and physical examination is questionable. The ECGtrial will investigate the efficacy of routine preoperative electrocardiography in patients undergoing non-cardiac surgery.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 26, 2009

Completed
Last Updated

July 31, 2013

Status Verified

July 1, 2013

First QC Date

June 25, 2009

Last Update Submit

July 30, 2013

Conditions

Keywords

ElectrocardiogramElectrocardiographyPerioperative carePreoperative carePreanesthesia EvaluationAcute Coronary SyndromePostoperative Myocardial InfarctionMyocardial ischaemiaPostoperative Cardiac DeathIntraoperative complicationsPostoperative complicationsCost-effectiveness analysis

Outcome Measures

Primary Outcomes (1)

  • Cardiac death or perioperative myocardial infarction

    2 days postoperatively

Secondary Outcomes (3)

  • Other major cardiovascular complications

    2 days postoperatively

  • Death from other causes

    2 days postoperatively

  • Long term quality of life

    One year

Study Arms (2)

Regular preanesthesia evaluation

Patients are evaluated by the anesthesiologist according to current protocol, including routine preoperative ECG.

New preanesthesia evaluation

Patients are evaluated by the anesthesiologist according to a new protocol, in which a routine preoperative ECG is no longer provided.

Procedure: Removal of preoperative electrocardiogram

Interventions

A new preanesthesia evaluation strategy without routine ECG. Initially, all patients in the participating centers are assessed following the regular strategy (with routine ECG). The new strategy (without routine ECG) is rolled out to the participating hospitals sequentially. At the end of the trial all participating centers will use the new preoperative strategy.

New preanesthesia evaluation

Eligibility Criteria

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

All patients aged over 60 years, or younger patients with cardiovascular risk factors, scheduled for non-cardiac surgery with an expected postoperative hospital length of stay of at least 2 days.

You may qualify if:

  • All patients aged 60 years or older scheduled for noncardiac surgery with an expected hospital length of stay of at least 2 days
  • Patients aged under 60 years but with risk factors for cardiovascular disease scheduled for noncardiac surgery with an expected hospital length of stay of at least 2 days

You may not qualify if:

  • Patients refusing informed consent for obtaining blood samples (troponin measurement) at the first two days after surgery
  • Patients refusing participation in long-term clinical and Quality of Life measurements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Utrecht

Utrecht, 3508 GA, Netherlands

Location

Related Publications (1)

  • van Klei WA, Bryson GL, Yang H, Kalkman CJ, Wells GA, Beattie WS. The value of routine preoperative electrocardiography in predicting myocardial infarction after noncardiac surgery. Ann Surg. 2007 Aug;246(2):165-70. doi: 10.1097/01.sla.0000261737.62514.63.

    PMID: 17667491BACKGROUND

MeSH Terms

Conditions

Acute Coronary SyndromeMyocardial InfarctionHeart ArrestCoronary Artery DiseaseIntraoperative ComplicationsPostoperative Complications

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Cor J Kalkman, MD PhD

    UMC Utrecht

    STUDY CHAIR
  • Wilton A van Klei, MD PhD

    UMC Utrecht

    PRINCIPAL INVESTIGATOR
  • Jurgen C de Graaff, MD PhD

    UMC Utrecht

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

June 25, 2009

First Posted

June 26, 2009

Last Updated

July 31, 2013

Record last verified: 2013-07

Locations