Clinical trial NCT02671084: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Myocardial Infarction
Keywords: Sevoflurane
Ck-MB
Lead sponsor: Instituto Dante Pazzanese de Cardiologia
Sponsor class: OTHER
First posted: 2016-02-02
Enrollment: 701
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Measure level of Ck-MB in all patients
timeFrame: 24 hours after coronary intervention
Secondary outcomes:
measure: Length of stay in hospital
timeFrame: 30 days after coronary intervention
measure: Length of stay in Intensive Care Unit (UCI)
timeFrame: 30 days after coronary intervention
measure: mortality rate
timeFrame: 1 year after coronary intervention
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Institute Dante Pazzanese of Cardiology
Study officials:
References:
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.
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.
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.