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Efficacy of Preoperative Electrocardiography

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Wilton A van Klei, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00928460
First received: June 25, 2009
Last updated: July 30, 2013
Last verified: July 2013

June 25, 2009
July 30, 2013
Not Provided
Not Provided
Cardiac death or perioperative myocardial infarction [ Time Frame: 2 days postoperatively ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00928460 on ClinicalTrials.gov Archive Site
  • Other major cardiovascular complications [ Time Frame: 2 days postoperatively ] [ Designated as safety issue: No ]
  • Death from other causes [ Time Frame: 2 days postoperatively ] [ Designated as safety issue: No ]
  • Long term quality of life [ Time Frame: One year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy of Preoperative Electrocardiography
The Efficacy of Routine Preoperative Electrocardiography in Patients Undergoing Non-cardiac Surgery

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.

Objective:

A routine ECG is performed as part of the standard diagnostic workup before non-cardiac surgery. However, the added value of this test beyond patient history and physical examination is questionable. The proposed study therefore aims to determine whether preoperative assessment without ECG is more cost-effective.

Study design:

Prospective stepped wedge design multicenter trial including 40,000 patients.

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 stay of at least 2 days.

Intervention:

A new preoperative assessment 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.

Outcome measures:

The primary outcome measure is cardiac death or perioperative myocardial infarction. The latter will be verified by Troponin values at postoperative day 1 and 2. If the Troponin levels are elevated the presence of myocardial infarction will be evaluated by a consulting cardiologist. Secondary outcomes are other major cardiovascular complications, death from other causes within 2 days of surgery, and long term quality of life. To determine cost-effectiveness of the strategy without ECG all pre- and postoperative referrals and interventions are taken into account.

Sample size calculation:

We expect no increase in the primary outcome in the intervention group. To rule out an 0.5% increase (from 3% to 3.5%) in the intervention group, the inclusion of 36,504 patients is required (level of confidence: 0.95; power: 0.80). To compensate for expected 10% loss-to-follow up, 40,000 patients will be randomized.

Economic evaluation:

A cost-effectiveness analysis will be conducted when the increase in primary outcome is between 0.0 and 0.5%. If the intervention results in a lower prevalence of the primary outcome, no cost-effectiveness analysis is performed as the health and cost outcomes point in the same, advantageous, direction. An increase of more than 0.5% is not considered acceptable from a clinical point of view.

Observational
Time Perspective: Prospective
Not Provided
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Probability Sample

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.

  • Acute Coronary Syndrome
  • Myocardial Infarction
  • Cardiac Arrest
Procedure: Removal of preoperative electrocardiogram
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.
  • 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.
    Intervention: Procedure: Removal of preoperative electrocardiogram
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
Not Provided

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00928460
ECGtrial
Yes
Wilton A van Klei, UMC Utrecht
UMC Utrecht
Not Provided
Study Chair: Cor J Kalkman, MD PhD UMC Utrecht
Principal Investigator: Wilton A van Klei, MD PhD UMC Utrecht
Principal Investigator: Jurgen C de Graaff, MD PhD UMC Utrecht
UMC Utrecht
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP