Ignite Creation Date:
2024-05-06 @ 8:07 AM
Last Modification Date:
2024-10-26 @ 11:56 AM
Study NCT ID:
NCT02671084
Status:
TERMINATED
Last Update Posted:
2020-04-28
First Post:
2016-01-20
Brief Title:
Sevoflurane and Percutaneous Coronary Intervention by Stent
Sponsor:
Instituto Dante Pazzanese de Cardiologia
Organization:
Instituto Dante Pazzanese de Cardiologia
Study Overview
Official Title:
Effect of Sevoflurane on CKMB Release After PCI With Drug-eluting Stents a Randomised Trial
Status:
TERMINATED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
interim analysis suggests futility
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 graftCABG 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None