Acute Coronary SyndromeNCT00928460
Efficacy of Preoperative Electrocardiography
An observational study of Acute Coronary Syndrome and Myocardial Infarction, run by UMC Utrecht at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Myocardial Infarction, Cardiac Arrest
- What is being tested?
- Removal of preoperative electrocardiogram
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteNetherlands
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Removal of preoperative electrocardiogram
- 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
- Medical subject headings
- Acute Coronary Syndrome, Myocardial Infarction, Heart Arrest, Coronary Artery Disease, Intraoperative Complications, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Removal of preoperative electrocardiogramProcedure or surgery
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 | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Removal of preoperative electrocardiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac death or perioperative myocardial infarction
Measured: 2 days postoperatively
Secondary outcomes (3)
Other major cardiovascular complications
Measured: 2 days postoperatively
Death from other causes
Measured: 2 days postoperatively
Long term quality of life
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wilton A van Klei, UMC Utrecht
- Investigators
- Cor J Kalkman, MD PhD, Study chair, UMC UtrechtWilton A van Klei, MD PhD, Principal investigator, UMC UtrechtJurgen C de Graaff, MD PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00928460
- Sponsor's protocol ID
- ECGtrial
- Status last verified
- Jul 2013
- First submitted
- 25 Jun 2009
- Last updated
- 31 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1097/01.sla.0000261737.62514.63.
PubMed 17667491
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Routine Preoperative Electrocardiography in Patients Undergoing Non-cardiac Surgery
- ClinicalTrials.gov ID
- NCT00928460
- Acronym / sponsor ID
- ECGtrial
- Keywords
- Electrocardiogram, Electrocardiography, Perioperative care, Preoperative care, Preanesthesia Evaluation, Acute Coronary Syndrome, Postoperative Myocardial Infarction, Myocardial ischaemia
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- First posted
- 26 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular preanesthesia evaluation | – | –Patients are evaluated by the anesthesiologist according to current protocol, including routine preoperative ECG. |
| New preanesthesia evaluation | – | Procedure: Removal of preoperative electrocardiogramPatients are evaluated by the anesthesiologist according to a new protocol, in which a routine preoperative ECG is no longer provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Removal of preoperative electrocardiogramA 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. | Procedure or surgery | New preanesthesia evaluation |
Primary outcome
Cardiac death or perioperative myocardial infarction
Time frame: 2 days postoperatively
3 secondary outcomes
Other major cardiovascular complications
Time frame: 2 days postoperatively
Death from other causes
Time frame: 2 days postoperatively
Long term quality of life
Time frame: One year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2013.
- Background: PubMed 17667491van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cor J Kalkman, MD PhD study chair
UMC Utrecht
Wilton A van Klei, MD PhD principal investigator
UMC Utrecht
Jurgen C de Graaff, MD PhD principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome and Myocardial Infarction, run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac death or perioperative myocardial infarction (time frame: 2 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00928460, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2013.