Coronary Artery DiseasePhase 4NCT00286585
TEAM-Project: Trial on the Effect of Anesthetics on Morbidity and Mortality
A Phase 4 study testing Inhalational anesthetic and Intravenous anesthetic, propofol in people with Coronary Artery Disease, run by University Hospital, Basel, Switzerland at 3 sites in Switzerland.
Trial summary
Volatile anesthetics may provide some protection from myocardial ischemia, an effect called anesthetic preconditioning. In patients undergoing coronary artery bypass surgery, this preconditioning effect resulted in better cardiac performance, faster recovery and lower morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Inhalational anesthetic and Intravenous anesthetic, propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 385 participants
- Where
- 3 sitesSwitzerland
- Study dates
- Feb 2006to Nov 2011
- Phase
- Phase 4
- 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
Who may be able to join
- Patients scheduled for a non-cardiac surgical procedure of high or intermediate cardiac risk are eligible if they have documented coronary artery disease (CAD) or are at high risk of CAD.
Who cannot join
- Ongoing medication with sulfonylurea derivatives (unless stopped ≥ 2 days before surgery) or theophylline
- Emergency surgery
- Unstable angina pectoris
- Preoperative hemodynamic instability
- Severe hepatic disease
- Renal insufficiency (creatinine clearance < 30 ml/min)
- Severe chronic obstructive pulmonary disease (forced expiratory volume in 1 second [FEV1] < 1 litre)
- Absence of written patient consent
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
University Hospital
Basel, Basel, CH-4000
Kantonsspital
Liestal, Basel-Landschaft, CH-4410
Bürgerspital
Solothurn, Canton of Solothurn, CH-4500
About this study
Official title: Multi-Center Trial on the Effect of Anesthetics on Morbidity and Mortality in Patients Undergoing Major Non-cardiac Surgery
Volatile anesthetics may provide some protection from myocardial ischemia, an effect called anesthetic preconditioning. In patients undergoing coronary artery bypass surgery, this preconditioning effect resulted in better cardiac performance, faster recovery and lower morbidity and mortality.
The investigators will perform a prospective randomized multi-center study to compare volatile with total intravenous anesthesia in patients at a high cardiac risk who undergo major non-cardiac surgery.
Read the detailed description
Basic research and animal studies have detected that volatile anesthetics provide some protection from myocardial ischemia, an effect called anesthetic preconditioning. Recent clinical studies have found that this preconditioning effect is of clinical relevance in patients undergoing coronary artery bypass surgery, resulting in better cardiac function and faster recovery after surgery, and in lower one-year morbidity. In patients undergoing non cardiac surgery, cardiac complications also are the major cause of perioperative morbidity and mortality. Myocardial ischemia frequently occurs during and immediately after non cardiac surgery in patients with coronary artery disease, and is a strong predictor of subsequent cardiac complications and death. Whether or not volatile anesthetics also provide clinically relevant protection from perioperative ischemia and subsequent cardiac complications in patients undergoing non cardiac surgery is unknown. Therefore, we will perform a prospective, randomized multi-center study to compare volatile with total intravenous anesthesia in patients at high cardiac risk who undergo major non cardiac surgery. We hypothesize that the use of a volatile anesthetic will reduce the incidence of perioperative ischaemia and myocardial injury, as indicated primarily by less ST-segment changes in the Holter ECG and, if there will be an effect, secondarily by lower incidences of elevated troponin T and NT-pro-BNP levels. And we hypothesize that the use of a volatile anesthetic will reduce the one-year incidence of cardiac complications and all cause mortality after surgery. The results of this study may apply to a huge percentage of surgical patients because coronary artery disease is the clinically most relevant co-morbidity, and its prevalence is expected to increase with the steadily increasing number of surgical patients aged 65 yr and older.
- Conditions
- Coronary Artery Disease
- Being tested
- Inhalational anesthetic, Intravenous anesthetic, propofol
- Keywords
- preconditioning, cardiac protection, morbidity, mortality, major non-cardiac surgery, cardiac mortality and morbidity, high cardiac perioperative risk
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhalational anestheticDrug
Also called Ultane,, Sevorane
Sevoflurane, dosage according to the physician in charge
Intravenous anesthetic, propofolDrug
Also called Diprivan,, Diprovan
Propofol, dosage according to the physician in charge
| Study group | Role | What they receive |
|---|---|---|
| Inhalational anesthetic | Active comparator | Sevoflurane will be used as the main anesthetic in this arm, and no propofol will be administered Receives: Drug: Inhalational anesthetic |
| Intravenous anesthetic, propofol | Active comparator | Propofol will be used as the main anesthetic in this arm, and no inhalational anesthetic will be administered Receives: Drug: Intravenous anesthetic, propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ischemia (Holter-electrocardiogram [ECG], troponin T, ECG)
Measured: 7 days postoperatively
Secondary outcomes (3)
Congestive heart failure (N-terminal B-type natriuretic peptide [NT-pro-BNP])
Measured: 2 days postoperatively
influence of genetic polymorphism on cardiac morbidity and mortality
Measured: 7 days, 6 and 12 months
cardiac morbidity and mortality
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2006 (estimated)
- Study startFeb 2006
- Primary completionNov 2010
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
- Investigators
- Manfred Seeberger, Prof. Dr., Principal investigator, Department of Anesthesia, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00286585
- Sponsor's protocol ID
- 261/05
- Other IDs
- IIS-SWIT-05-002
- Status last verified
- Aug 2012
- First submitted
- 2 Feb 2006
- Last updated
- 27 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mauermann E, Bolliger D, Seeberger E, Puelacher C, Corbiere S, Filipovic M, Seeberger M, Mueller C, Lurati Buse G. Incremental Value of Preoperative Copeptin for Predicting Myocardial Injury. Anesth Analg. 2016 Dec;123(6):1363-1371. doi: 10.1213/ANE.0000000000001635.
PubMed 27870734Lurati Buse GA, Schumacher P, Seeberger E, Studer W, Schuman RM, Fassl J, Kasper J, Filipovic M, Bolliger D, Seeberger MD. Randomized comparison of sevoflurane versus propofol to reduce perioperative myocardial ischemia in patients undergoing noncardiac surgery. Circulation. 2012 Dec 4;126(23):2696-704. doi: 10.1161/CIRCULATIONAHA.112.126144. Epub 2012 Nov 7.
PubMed 23136158
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Trial on the Effect of Anesthetics on Morbidity and Mortality in Patients Undergoing Major Non-cardiac Surgery
- ClinicalTrials.gov ID
- NCT00286585
- Acronym / sponsor ID
- 261/05
- Conditions
- Coronary Artery Disease
- Keywords
- preconditioning, cardiac protection, morbidity, mortality, major non-cardiac surgery, cardiac mortality and morbidity, high cardiac perioperative risk
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Feb 2006
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 3 Feb 2006 (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.
Volatile anesthetics may provide some protection from myocardial ischemia, an effect called anesthetic preconditioning. In patients undergoing coronary artery bypass surgery, this preconditioning effect resulted in better cardiac performance, faster recovery and lower morbidity and mortality.
The investigators will perform a prospective randomized multi-center study to compare volatile with total intravenous anesthesia in patients at a high cardiac risk who undergo major non-cardiac surgery.
Detailed description
Basic research and animal studies have detected that volatile anesthetics provide some protection from myocardial ischemia, an effect called anesthetic preconditioning. Recent clinical studies have found that this preconditioning effect is of clinical relevance in patients undergoing coronary artery bypass surgery, resulting in better cardiac function and faster recovery after surgery, and in lower one-year morbidity. In patients undergoing non cardiac surgery, cardiac complications also are the major cause of perioperative morbidity and mortality. Myocardial ischemia frequently occurs during and immediately after non cardiac surgery in patients with coronary artery disease, and is a strong predictor of subsequent cardiac complications and death. Whether or not volatile anesthetics also provide clinically relevant protection from perioperative ischemia and subsequent cardiac complications in patients undergoing non cardiac surgery is unknown. Therefore, we will perform a prospective, randomized multi-center study to compare volatile with total intravenous anesthesia in patients at high cardiac risk who undergo major non cardiac surgery. We hypothesize that the use of a volatile anesthetic will reduce the incidence of perioperative ischaemia and myocardial injury, as indicated primarily by less ST-segment changes in the Holter ECG and, if there will be an effect, secondarily by lower incidences of elevated troponin T and NT-pro-BNP levels. And we hypothesize that the use of a volatile anesthetic will reduce the one-year incidence of cardiac complications and all cause mortality after surgery. The results of this study may apply to a huge percentage of surgical patients because coronary artery disease is the clinically most relevant co-morbidity, and its prevalence is expected to increase with the steadily increasing number of surgical patients aged 65 yr and older.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhalational anesthetic | Active comparator | Drug: Inhalational anestheticSevoflurane will be used as the main anesthetic in this arm, and no propofol will be administered |
| Intravenous anesthetic, propofol | Active comparator | Drug: Intravenous anesthetic, propofolPropofol will be used as the main anesthetic in this arm, and no inhalational anesthetic will be administered |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for a non-cardiac surgical procedure of high or intermediate cardiac risk are eligible if they have documented coronary artery disease (CAD) or are at high risk of CAD.
Key exclusion criteria (8 listed)
- Ongoing medication with sulfonylurea derivatives (unless stopped ≥ 2 days before surgery) or theophylline
- Emergency surgery
- Unstable angina pectoris
- Preoperative hemodynamic instability
- Severe hepatic disease
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 |
|---|---|---|
| Inhalational anestheticAlso: Ultane,, SevoraneSevoflurane, dosage according to the physician in charge | Drug | Inhalational anesthetic |
| Intravenous anesthetic, propofolAlso: Diprivan,, DiprovanPropofol, dosage according to the physician in charge | Drug | Intravenous anesthetic, propofol |
Primary outcome
Ischemia (Holter-electrocardiogram [ECG], troponin T, ECG)
Time frame: 7 days postoperatively
3 secondary outcomes
Congestive heart failure (N-terminal B-type natriuretic peptide [NT-pro-BNP])
Time frame: 2 days postoperatively
influence of genetic polymorphism on cardiac morbidity and mortality
Time frame: 7 days, 6 and 12 months
cardiac morbidity and mortality
Time frame: 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2012.
- Derived from this study: PubMed 27870734Mauermann E, Bolliger D, Seeberger E, Puelacher C, Corbiere S, Filipovic M, Seeberger M, Mueller C, Lurati Buse G. Incremental Value of Preoperative Copeptin for Predicting Myocardial Injury. Anesth Analg. 2016 Dec;123(6):1363-1371. doi: 10.1213/ANE.0000000000001635.
- Derived from this study: PubMed 23136158Lurati Buse GA, Schumacher P, Seeberger E, Studer W, Schuman RM, Fassl J, Kasper J, Filipovic M, Bolliger D, Seeberger MD. Randomized comparison of sevoflurane versus propofol to reduce perioperative myocardial ischemia in patients undergoing noncardiac surgery. Circulation. 2012 Dec 4;126(23):2696-704. doi: 10.1161/CIRCULATIONAHA.112.126144. Epub 2012 Nov 7.
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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.
Manfred Seeberger, Prof. Dr. principal investigator
Department of Anesthesia, University Hospital, Basel, Switzerland
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Inhalational anesthetic and Intravenous anesthetic, propofol in people with Coronary Artery Disease, run by University Hospital, Basel, Switzerland at 3 sites in Switzerland.
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 1 inclusion and 8 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: finished, as of the sponsor's last update on 27 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ischemia (Holter-electrocardiogram [ECG], troponin T, ECG) (time frame: 7 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 NCT00286585, which also lists 2 linked publications.
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 27 Aug 2012.