Myocardial InfarctionPhase 4NCT02671084
Sevoflurane and Percutaneous Coronary Intervention by Stent
A Phase 4 study testing sevoflurane in people with Myocardial Infarction, run by Instituto Dante Pazzanese de Cardiologia at 1 site in Brazil.
Trial summary
Increase in CK-MB after percutaneous coronary angioplasty more than 100% of baseline can represents a problem to the patients resulting in increase of morbidity and mortality. Patients submitted of coronary angioplasty procedures can release in varying degrees of creatine kinase, MB isoform (CK - MB), on the order of… Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- sevoflurane
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 701 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2016to Apr 2020
- 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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Both gender.
- Patients with coronary artery disease candidates for coronary angioplasty stent.
- Cardiac catheterization on an urgent basis.
- Coronary angioplasty in elective and urgency.
- Age less than 80 years.
Who cannot join
- Patients aged greater than or equal of 80 years.
- Angioplasty balloon catheter statement.
- Myocardial infarction with ST-segment elevation.
- Angioplasty in saphenous vein grafts in patients after surgical revascularization.
- Patient pregnant.
- Dialytic insufficiency renal.
- Patients submited a urgent cardiac catheterization but not progress with coronary angioplasty stent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Sevoflurane on CKMB Release After PCI With Drug-eluting Stents: a Randomised Trial
Increase in CK-MB after percutaneous coronary angioplasty more than 100% of baseline can represents a problem to the patients resulting in increase of morbidity and mortality.
Patients submitted of coronary angioplasty procedures can release in varying degrees of creatine kinase, MB isoform (CK - MB), on the order of 30% of all angioplasty.
Possibly patients who will receive sevoflurane experience a higher level of cardiac cell protection with lower incidence in the release of CK - MB values in excess of 100% baseline.
Read the detailed description
Several published clinical studies have shown the benefit of using inhaled anesthetic agents in patients undergoing coronary artery bypass graft(CABG). These benefits involve functional state of the heart and reduction damage to the organ. These events are related to intracellular phenomena that result in intracellular calcium homeostasis giving physical and functional benefits to the heart. Also disclosed is a modulation of the inflammatory response to endothelial level with resulting protective character to the coronary bed.
Patients submitted of coronary angioplasty procedures can release in varying degrees of creatine kinase, MB isoform (CK - MB), on the order of 30% of all angioplasty. Even in smaller increases than 3 times baseline, a criterion that defines myocardial infarction, clinical impact can already be found. Increase in CK-MB more than 100% of baseline can represents a problem to the patients. This elevation of CK - MB is associated with various factors such as age, characteristic of the lesion, clinical status of the patient, inferring that endovascular procedures of coronary, simple or complex, have associated myocardial damage, which depending on the intensity of the damage, results in increased morbidity and mortality.
BACKGROUND AND OBJECTIVES:
Check for reduction in the percentage of patients that release CK -MB at levels above the 100% baseline in patients anesthetized with sevoflurane compared to the control group. Possibly patients who will receive sevoflurane experience a higher level of cardiac cell protection with lower incidence in the release of CK - MB values in excess of 100% baseline.
- Conditions
- Myocardial Infarction
- Being tested
- sevoflurane
- Keywords
- Sevoflurane, Ck-MB
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sevofluraneDrug
compare effect of sevoflurane when administered before PCI
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane Group | Experimental | Sevoflurane Group called group A patients will receive sevoflurane. The patients of group A will receive facial mask properly attached to your face, inspiratory fraction of sevoflurane 3%, with therapeutic target of 1.2% expired fraction into spontaneously breathing.This exposure will during 30 min. Than, the mask will remove of the face and the patient will spontaneously breathing in ambient air during 10 min. This procedure is sufficient to induce the pre anesthetic conditioning in the group exposed to sevoflurane. After the end of this exhibition, patients will be allowed to enter the catheterization laboratory for angioplasty, no more any anesthetic agent will be administer until the end of his procedure. Receives: Drug: sevoflurane |
| Control Group | Placebo comparator | Control Group called group B patients who will not receive sevoflurane. The patient of group B will receive facial mask properly attached to your face into spontaneously breathing.This exposure will during 30 min. Than, the mask will remove of the face and the patient will spontaneously breathing in ambient air during 10 min. After the end of this exhibition, patients will be allowed to enter the catheterization laboratory for angioplasty, no more any anesthetic agent will be administer until the end of his procedure. Receives: Drug: sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure level of Ck-MB in all patients
Measured: 24 hours after coronary intervention
Secondary outcomes (3)
Length of stay in hospital
It will be quantified the length of hospital stay of patients who underwent coronary intervention checking if there is difference between groups
Measured: 30 days after coronary intervention
Length of stay in Intensive Care Unit (UCI)
The length of stay in UCI will be quantified if patients who underwent coronary intervention are referred to this sector
Measured: 30 days after coronary intervention
mortality rate
Measured: 1 year after coronary intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionApr 2020
- Study completionApr 2020
Why it stopped: interim analysis suggests futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 701 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Dante Pazzanese de Cardiologia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RONALDO ROSSI JUNIOR, Instituto Dante Pazzanese de Cardiologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02671084
- Sponsor's protocol ID
- 090106/2015
- Status last verified
- Apr 2020
- First submitted
- 20 Jan 2016
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- Individual data sharing
- Yes: Data will be published in journals
Publications
Landoni G, Zangrillo A, Fochi O, Maj G, Scandroglio AM, Morelli A, Tritapepe L, Montorfano M, Colombo A. Cardiac protection with volatile anesthetics in stenting procedures. J Cardiothorac Vasc Anesth. 2008 Aug;22(4):543-7. doi: 10.1053/j.jvca.2008.02.020. Epub 2008 May 14.
PubMed 18662628Jang JS, Jin HY, Seo JS, Yang TH, Kim DK, Kim DS, Cho KI, Kim BH, Je HG, Park YH. Prognostic value of creatine kinase-myocardial band isoenzyme elevation following percutaneous coronary intervention: a meta-analysis. Catheter Cardiovasc Interv. 2013 May;81(6):959-67. doi: 10.1002/ccd.24542. Epub 2012 Nov 14.
PubMed 22744792Lavi 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 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sevoflurane on CKMB Release After PCI With Drug-eluting Stents: a Randomised Trial
- ClinicalTrials.gov ID
- NCT02671084
- Acronym / sponsor ID
- 090106/2015
- Conditions
- Myocardial Infarction
- Keywords
- Sevoflurane, Ck-MB
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: interim analysis suggests futility
- Enrolment
- 701 participants (actual)
- Lead sponsor
- Instituto Dante Pazzanese de CardiologiaUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Apr 2020 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 2 Feb 2016 (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.
Increase in CK-MB after percutaneous coronary angioplasty more than 100% of baseline can represents a problem to the patients resulting in increase of morbidity and mortality.
Patients submitted of coronary angioplasty procedures can release in varying degrees of creatine kinase, MB isoform (CK - MB), on the order of 30% of all angioplasty.
Possibly patients who will receive sevoflurane experience a higher level of cardiac cell protection with lower incidence in the release of CK - MB values in excess of 100% baseline.
Detailed description
Several published clinical studies have shown the benefit of using inhaled anesthetic agents in patients undergoing coronary artery bypass graft(CABG). These benefits involve functional state of the heart and reduction damage to the organ. These events are related to intracellular phenomena that result in intracellular calcium homeostasis giving physical and functional benefits to the heart. Also disclosed is a modulation of the inflammatory response to endothelial level with resulting protective character to the coronary bed.
Patients submitted of coronary angioplasty procedures can release in varying degrees of creatine kinase, MB isoform (CK - MB), on the order of 30% of all angioplasty. Even in smaller increases than 3 times baseline, a criterion that defines myocardial infarction, clinical impact can already be found. Increase in CK-MB more than 100% of baseline can represents a problem to the patients. This elevation of CK - MB is associated with various factors such as age, characteristic of the lesion, clinical status of the patient, inferring that endovascular procedures of coronary, simple or complex, have associated myocardial damage, which depending on the intensity of the damage, results in increased morbidity and mortality.
BACKGROUND AND OBJECTIVES:
Check for reduction in the percentage of patients that release CK -MB at levels above the 100% baseline in patients anesthetized with sevoflurane compared to the control group. Possibly patients who will receive sevoflurane experience a higher level of cardiac cell protection with lower incidence in the release of CK - MB values in excess of 100% baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane Group | Experimental | Drug: sevofluraneSevoflurane Group called group A patients will receive sevoflurane. The patients of group A will receive facial mask properly attached to your face, inspiratory fraction of sevoflurane 3%, with therapeutic target of 1.2% expired fraction into spontaneously breathing.This exposure will during 30 min. Than, the mask will remove of the face and the patient will spontaneously breathing in ambient air during 10 min. This procedure is sufficient to induce the pre anesthetic conditioning in the group exposed to sevoflurane. After the end of this exhibition, patients will be allowed to enter the catheterization laboratory for angioplasty, no more any anesthetic agent will be administer until the end of his procedure. |
| Control Group | Placebo comparator | Drug: sevofluraneControl Group called group B patients who will not receive sevoflurane. The patient of group B will receive facial mask properly attached to your face into spontaneously breathing.This exposure will during 30 min. Than, the mask will remove of the face and the patient will spontaneously breathing in ambient air during 10 min. After the end of this exhibition, patients will be allowed to enter the catheterization laboratory for angioplasty, no more any anesthetic agent will be administer until the end of his procedure. |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Both gender.
- Patients with coronary artery disease candidates for coronary angioplasty stent.
- Cardiac catheterization on an urgent basis.
- Coronary angioplasty in elective and urgency.
- Age less than 80 years.
Key exclusion criteria (7 listed)
- Patients aged greater than or equal of 80 years.
- Angioplasty balloon catheter statement.
- Myocardial infarction with ST-segment elevation.
- Angioplasty in saphenous vein grafts in patients after surgical revascularization.
- Patient pregnant.
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 |
|---|---|---|
| sevofluranecompare effect of sevoflurane when administered before PCI | Drug | Control Group, Sevoflurane Group |
Primary outcome
Measure level of Ck-MB in all patients
Time frame: 24 hours after coronary intervention
3 secondary outcomes
Length of stay in hospital
Time frame: 30 days after coronary intervention
Length of stay in Intensive Care Unit (UCI)
Time frame: 30 days after coronary intervention
mortality rate
Time frame: 1 year after coronary intervention
Results and safety
The study was stopped early (reason given: interim analysis suggests futility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- Results publication: PubMed 18662628Landoni G, Zangrillo A, Fochi O, Maj G, Scandroglio AM, Morelli A, Tritapepe L, Montorfano M, Colombo A. Cardiac protection with volatile anesthetics in stenting procedures. J Cardiothorac Vasc Anesth. 2008 Aug;22(4):543-7. doi: 10.1053/j.jvca.2008.02.020. Epub 2008 May 14.
- Results publication: PubMed 22744792Jang JS, Jin HY, Seo JS, Yang TH, Kim DK, Kim DS, Cho KI, Kim BH, Je HG, Park YH. Prognostic value of creatine kinase-myocardial band isoenzyme elevation following percutaneous coronary intervention: a meta-analysis. Catheter Cardiovasc Interv. 2013 May;81(6):959-67. doi: 10.1002/ccd.24542. Epub 2012 Nov 14.
- Results publication: 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.
- Cardiac protection with volatile anesthetics in stenting procedures.Link provided by the sponsor.
- Prognostic value of creatine kinase-myocardial band isoenzyme elevation following percutaneous coronary intervention: a meta-analysis.Link provided by the sponsor.
- One-year outcome of the sevoflurane in acute myocardial infarction randomized trial.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data will be published in journals
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sevoflurane in people with Myocardial Infarction, run by Instituto Dante Pazzanese de Cardiologia at 1 site in Brazil.
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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 28 Apr 2020. 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 Brazil. 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 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 was stopped early (reason given: interim analysis suggests futility). Results are not available in the source record.
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?
Measure level of Ck-MB in all patients (time frame: 24 hours after coronary intervention). 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 NCT02671084, which also lists 3 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 28 Apr 2020.