Acute Myocardial InfarctionPhase 2SIAMINCT00971607
Sevoflurane In Acute Myocardial Infarction
A Phase 2 study testing Oxygen + Sevoflurane in people with Acute Myocardial Infarction, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Ischemic postconditioning can reduce myocardial injury following myocardial infarction. A potential pharmacological agent is the anesthetic Sevoflurane. The investigators' hypothesis is that sevoflurane during primary percutaneous coronary intervention (PCI) will reduce infarct size. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Oxygen + Sevoflurane
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- May 2009to Dec 2013
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First STEMI, presenting within 6 hours after the onset of chest pain
- Symptoms lasting > 30 minutes
- Persistent ST-segment elevation > 0.1 mV in 2 or more contiguous leads
Who cannot join
- Hypersensitivity to sevoflurane or other halogenated agents
- Malignant hyperthermia
- Cardiac arrest
- Cardiogenic shock
- Previous myocardial infarction or coronary bypass surgery
- Pre-infarction angina
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- Heart failure (NYHA III/IV)
- Chronic inflammatory disease
- Severe renal impairment
- Hepatic dysfunction
- Use of Glyburide
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sevoflurane Sedation During Primary Percutaneous Coronary Intervention.
Ischemic postconditioning can reduce myocardial injury following myocardial infarction.
A potential pharmacological agent is the anesthetic Sevoflurane. The investigators' hypothesis is that sevoflurane during primary percutaneous coronary intervention (PCI) will reduce infarct size.
Read the detailed description
Patients with first STEMI that will be treated by primary PCI, will be randomized to sedation with Sevoflurane during the procedure or to usual care.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Oxygen + Sevoflurane, Oxygen (placebo)
- Keywords
- Acute myocardial infarction, Postconditioning, Sevoflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen + SevofluraneDrug
Oxygen with end-tidal MAC of Sevoflurane 0.5 during PCI.
Oxygen (placebo)Drug
Control will receive oxygen only.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Sevoflurane Receives: Drug: Oxygen + Sevoflurane |
| 2 | Placebo comparator | Oxygen Receives: Drug: Oxygen (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infarct size by area under the curve of cardiac markers.
Measured: 3 days
Secondary outcomes (6)
Left ventricular function.
Measured: Six month
ST segment elevation resolution
Measured: 90 minutes
TIMI flow
Measured: 60 minutes
Renal function
Measured: 48 hours
CRP
Measured: 24 hours
Patient satisfaction
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2009 (estimated)
- Study startMay 2009
- Primary completionDec 2013
- Study completionDec 2013
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 Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahar Lavi, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Shahar Lavi, MD, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00971607
- Sponsor's protocol ID
- R-09-165
- Other IDs
- 15793
- Acronym
- SIAMI
- Status last verified
- Sep 2014
- First submitted
- 9 Jul 2009
- Last updated
- 9 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Lavi S, Alemayehu M, McCarty D, Warrington J, Lavi R. One-year outcome of the sevoflurane in acute myocardial infarction randomized trial. Can J Anaesth. 2015 Dec;62(12):1279-86. doi: 10.1007/s12630-015-0456-2. Epub 2015 Aug 22.
PubMed 26296299
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sevoflurane Sedation During Primary Percutaneous Coronary Intervention.
- ClinicalTrials.gov ID
- NCT00971607
- Acronym / sponsor ID
- SIAMI / R-09-165
- Conditions
- Acute Myocardial Infarction
- Keywords
- Acute myocardial infarction, Postconditioning, Sevoflurane
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 3 Sep 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.
Ischemic postconditioning can reduce myocardial injury following myocardial infarction.
A potential pharmacological agent is the anesthetic Sevoflurane. The investigators' hypothesis is that sevoflurane during primary percutaneous coronary intervention (PCI) will reduce infarct size.
Detailed description
Patients with first STEMI that will be treated by primary PCI, will be randomized to sedation with Sevoflurane during the procedure or to usual care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Oxygen + SevofluraneSevoflurane |
| 2 | Placebo comparator | Drug: Oxygen (placebo)Oxygen |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- First STEMI, presenting within 6 hours after the onset of chest pain
- Symptoms lasting > 30 minutes
- Persistent ST-segment elevation > 0.1 mV in 2 or more contiguous leads
Key exclusion criteria (11 listed)
- Hypersensitivity to sevoflurane or other halogenated agents
- Malignant hyperthermia
- Cardiac arrest
- Cardiogenic shock
- Previous myocardial infarction or coronary bypass surgery
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 |
|---|---|---|
| Oxygen + SevofluraneOxygen with end-tidal MAC of Sevoflurane 0.5 during PCI. | Drug | 1 |
| Oxygen (placebo)Control will receive oxygen only. | Drug | 2 |
Primary outcome
Infarct size by area under the curve of cardiac markers.
Time frame: 3 days
6 secondary outcomes
Left ventricular function.
Time frame: Six month
ST segment elevation resolution
Time frame: 90 minutes
TIMI flow
Time frame: 60 minutes
Renal function
Time frame: 48 hours
CRP
Time frame: 24 hours
Patient satisfaction
Time frame: 1 hour
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 9 Sep 2014.
- Derived from this study: PubMed 26296299Lavi S, Alemayehu M, McCarty D, Warrington J, Lavi R. One-year outcome of the sevoflurane in acute myocardial infarction randomized trial. Can J Anaesth. 2015 Dec;62(12):1279-86. doi: 10.1007/s12630-015-0456-2. Epub 2015 Aug 22.
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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.
Shahar Lavi, MD principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxygen + Sevoflurane in people with Acute Myocardial Infarction, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 3 inclusion and 11 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 9 Sep 2014. 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 Canada. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Infarct size by area under the curve of cardiac markers. (time frame: 3 days). 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 NCT00971607, 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 9 Sep 2014.