Trial record 2 of 2388 for:    electrocardiogram

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This study has been withdrawn prior to enrollment.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
  Purpose

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.


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

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Efficacy of Routine Preoperative Electrocardiography in Patients Undergoing Non-cardiac Surgery

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Cardiac death or perioperative myocardial infarction [ Time Frame: 2 days postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 0
Groups/Cohorts Assigned Interventions
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
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00928460

Locations
Netherlands
University Medical Center Utrecht
Utrecht, Netherlands, 3508 GA
Sponsors and Collaborators
UMC Utrecht
Investigators
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
  More Information

Publications:
Responsible Party: Wilton A van Klei, MD PhD, UMC Utrecht
ClinicalTrials.gov Identifier: NCT00928460     History of Changes
Other Study ID Numbers: ECGtrial
Study First Received: June 25, 2009
Last Updated: July 30, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by UMC Utrecht:
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

Additional relevant MeSH terms:
Infarction
Syndrome
Myocardial Infarction
Acute Coronary Syndrome
Heart Arrest
Ischemia
Pathologic Processes
Necrosis
Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014