Sevoflurane and Percutaneous Coronary Intervention by Stent

Myocardial Infarction Clinical Trial

Official title:

Effect of Sevoflurane on CKMB Release After PCI With Drug-eluting Stents: a Randomised Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02671084
• Other study ID #: 090106/2015
• Status: Terminated
• Phase: Phase 4
• Start date: February 2016
• Est. completion date: April 2020

Study information

• Verified date: April 2020
• Source: Instituto Dante Pazzanese de Cardiologia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 701
• Est. completion date: April 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Drug:
• sevoflurane
compare effect of sevoflurane when administered before PCI

Locations

Country	Name	City	State
Brazil	Institute Dante Pazzanese of Cardiology	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Dante Pazzanese de Cardiologia

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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;8 — View 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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure level of Ck-MB in all patients		24 hours after coronary intervention
Secondary	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	30 days after coronary intervention
Secondary	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	30 days after coronary intervention
Secondary	mortality rate		1 year after coronary intervention

External Links

•   Cardiac protection with volatile anesthetics in stenting procedures.
•   One-year outcome of the sevoflurane in acute myocardial infarction randomized trial.
•   Prognostic value of creatine kinase-myocardial band isoenzyme elevation following percutaneous coronary intervention: a meta-analysis.