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Sevoflurane and Percutaneous Coronary Intervention by Stent

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ClinicalTrials.gov Identifier: NCT02671084
Recruitment Status : Terminated (interim analysis suggests futility)
First Posted : February 2, 2016
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
RONALDO ROSSI JUNIOR, Instituto Dante Pazzanese de Cardiologia

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.


Condition or disease Intervention/treatment Phase
Myocardial Infarction Drug: sevoflurane Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 701 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Sevoflurane on CKMB Release After PCI With Drug-eluting Stents: a Randomised Trial
Actual Study Start Date : February 2016
Actual Primary Completion Date : April 2020
Actual Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Sevoflurane

Arm Intervention/treatment
Experimental: Sevoflurane Group
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.
Drug: sevoflurane
compare effect of sevoflurane when administered before PCI

Placebo Comparator: Control Group
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.
Drug: sevoflurane
compare effect of sevoflurane when administered before PCI




Primary Outcome Measures :
  1. Measure level of Ck-MB in all patients [ Time Frame: 24 hours after coronary intervention ]

Secondary Outcome Measures :
  1. Length of stay in hospital [ Time Frame: 30 days after coronary intervention ]
    It will be quantified the length of hospital stay of patients who underwent coronary intervention checking if there is difference between groups

  2. Length of stay in Intensive Care Unit (UCI) [ Time Frame: 30 days after coronary intervention ]
    The length of stay in UCI will be quantified if patients who underwent coronary intervention are referred to this sector

  3. mortality rate [ Time Frame: 1 year after coronary intervention ]


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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671084


Locations
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Brazil
Institute Dante Pazzanese of Cardiology
Sao Paulo, Brazil, 04012-909
Sponsors and Collaborators
Instituto Dante Pazzanese de Cardiologia
Additional Information:
Publications of Results:
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Responsible Party: RONALDO ROSSI JUNIOR, Principal Investigator, Instituto Dante Pazzanese de Cardiologia
ClinicalTrials.gov Identifier: NCT02671084    
Other Study ID Numbers: 090106/2015
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be published in journals
Supporting Materials: Study Protocol

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Studies a U.S. FDA-regulated Drug Product: No
Keywords provided by RONALDO ROSSI JUNIOR, Instituto Dante Pazzanese de Cardiologia:
Sevoflurane
Ck-MB
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Sevoflurane
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs