Clinical trial NCT00928460: Efficacy of Preoperative Electrocardiography
Official title: The Efficacy of Routine Preoperative Electrocardiography in Patients Undergoing Non-cardiac Surgery
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Acute Coronary Syndrome
Myocardial Infarction
Cardiac Arrest
Keywords: Electrocardiogram
Electrocardiography
Perioperative care
Preoperative care
Preanesthesia Evaluation
Acute Coronary Syndrome
Postoperative Myocardial Infarction
Myocardial ischaemia
Postoperative Cardiac Death
Intraoperative complications
Postoperative complications
Cost-effectiveness analysis
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2009-06-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_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.

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cardiac death or perioperative myocardial infarction
timeFrame: 2 days postoperatively
Secondary outcomes:
measure: Other major cardiovascular complications
timeFrame: 2 days postoperatively
measure: Death from other causes
timeFrame: 2 days postoperatively
measure: Long term quality of life
timeFrame: One year
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: UMC Utrecht
name: Cor J Kalkman, MD PhD
role: STUDY_CHAIR
affiliation: UMC Utrecht
name: Wilton A van Klei, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UMC Utrecht
name: Jurgen C de Graaff, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.