Study Stopped
interim analysis suggests futility
Sevoflurane and Percutaneous Coronary Intervention by Stent
Effect of Sevoflurane on CKMB Release After PCI With Drug-eluting Stents: a Randomised Trial
1 other identifier
interventional
701
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2016
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2016
CompletedStudy Start
First participant enrolled
February 1, 2016
CompletedFirst Posted
Study publicly available on registry
February 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2020
CompletedApril 28, 2020
April 1, 2020
4.2 years
January 20, 2016
April 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measure level of Ck-MB in all patients
24 hours after coronary intervention
Secondary Outcomes (3)
Length of stay in hospital
30 days after coronary intervention
Length of stay in Intensive Care Unit (UCI)
30 days after coronary intervention
mortality rate
1 year after coronary intervention
Study Arms (2)
Sevoflurane Group
EXPERIMENTALSevoflurane 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 COMPARATORControl 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.
Interventions
compare effect of sevoflurane when administered before PCI
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute Dante Pazzanese of Cardiology
São Paulo, 04012-909, Brazil
Related Publications (3)
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.
PMID: 18662628RESULTJang 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.
PMID: 22744792RESULTLavi 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.
PMID: 26296299RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 20, 2016
First Posted
February 2, 2016
Study Start
February 1, 2016
Primary Completion
April 1, 2020
Study Completion
April 1, 2020
Last Updated
April 28, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
Data will be published in journals