Efficacy of Preoperative Electrocardiography
Recruitment status was Not yet recruiting
|First Received Date ICMJE||June 25, 2009|
|Last Updated Date||November 22, 2010|
|Start Date ICMJE||Not Provided|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Cardiac death or perioperative myocardial infarction [ Time Frame: 2 days postoperatively ] [ Designated as safety issue: No ]|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00928460 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Efficacy of Preoperative Electrocardiography|
|Official Title ICMJE||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.
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.
Prospective stepped wedge design multicenter trial including 40,000 patients.
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.
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.
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.
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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||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.
|Intervention ICMJE||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.
|Study Group/Cohort (s)||
|Publications *||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.
|Recruitment Status ICMJE||Not yet recruiting|
|Estimated Enrollment ICMJE||40000|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||Netherlands|
|NCT Number ICMJE||NCT00928460|
|Other Study ID Numbers ICMJE||ECGtrial|
|Has Data Monitoring Committee||Yes|
|Responsible Party||JC de Graaff MD PhD & WA van Klei MD PhD, University Medical Center Utrecht|
|Study Sponsor ICMJE||UMC Utrecht|
|Collaborators ICMJE||Not Provided|
|Information Provided By||UMC Utrecht|
|Verification Date||November 2010|
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