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Sevoflurane and Percutaneous Coronary Intervention by Stent

Primary Purpose

Myocardial Infarction

Status
Terminated
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
sevoflurane
Sponsored by
Instituto Dante Pazzanese de Cardiologia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Sevoflurane, Ck-MB

Eligibility Criteria

undefined - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Both gender.
  2. Patients with coronary artery disease candidates for coronary angioplasty stent.
  3. Cardiac catheterization on an urgent basis.
  4. Coronary angioplasty in elective and urgency.
  5. Age less than 80 years.

Exclusion Criteria:

  1. Patients aged greater than or equal of 80 years.
  2. Angioplasty balloon catheter statement.
  3. Myocardial infarction with ST-segment elevation.
  4. Angioplasty in saphenous vein grafts in patients after surgical revascularization.
  5. Patient pregnant.
  6. Dialytic insufficiency renal.
  7. Patients submited a urgent cardiac catheterization but not progress with coronary angioplasty stent.

Sites / Locations

  • Institute Dante Pazzanese of Cardiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sevoflurane Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Measure level of Ck-MB in all patients

Secondary Outcome Measures

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
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
mortality rate

Full Information

First Posted
January 20, 2016
Last Updated
April 24, 2020
Sponsor
Instituto Dante Pazzanese de Cardiologia
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1. Study Identification

Unique Protocol Identification Number
NCT02671084
Brief Title
Sevoflurane and Percutaneous Coronary Intervention by Stent
Official Title
Effect of Sevoflurane on CKMB Release After PCI With Drug-eluting Stents: a Randomised Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Terminated
Why Stopped
interim analysis suggests futility
Study Start Date
February 2016 (Actual)
Primary Completion Date
April 2020 (Actual)
Study Completion Date
April 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Dante Pazzanese de Cardiologia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
Sevoflurane, Ck-MB

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
701 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sevoflurane Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
sevoflurane
Intervention Description
compare effect of sevoflurane when administered before PCI
Primary Outcome Measure Information:
Title
Measure level of Ck-MB in all patients
Time Frame
24 hours after coronary intervention
Secondary Outcome Measure Information:
Title
Length of stay in hospital
Description
It will be quantified the length of hospital stay of patients who underwent coronary intervention checking if there is difference between groups
Time Frame
30 days after coronary intervention
Title
Length of stay in Intensive Care Unit (UCI)
Description
The length of stay in UCI will be quantified if patients who underwent coronary intervention are referred to this sector
Time Frame
30 days after coronary intervention
Title
mortality rate
Time Frame
1 year after coronary intervention

10. Eligibility

Sex
All
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Institute Dante Pazzanese of Cardiology
City
Sao Paulo
ZIP/Postal Code
04012-909
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be published in journals
Citations:
PubMed Identifier
18662628
Citation
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.
Results Reference
result
PubMed Identifier
22744792
Citation
Jang 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 Reference
result
PubMed Identifier
26296299
Citation
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.
Results Reference
result
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/18662628
Description
Cardiac protection with volatile anesthetics in stenting procedures.
URL
http://www.ncbi.nlm.nih.gov/pubmed/22744792
Description
Prognostic value of creatine kinase-myocardial band isoenzyme elevation following percutaneous coronary intervention: a meta-analysis.
URL
http://www.ncbi.nlm.nih.gov/pubmed/26296299
Description
One-year outcome of the sevoflurane in acute myocardial infarction randomized trial.

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Sevoflurane and Percutaneous Coronary Intervention by Stent

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