Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00375518
Status:
COMPLETED
Last Update Posted:
2021-01-06
First Post:
2006-09-11
Brief Title:
Study of Atorvastatin Versus Placebo to Reduce Cardiopulmonary Complications After Thoracic Surgery
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Double-Blind Study of Atorvastatin Versus Placebo to Reduce Cardiopulmonary Complications After Thoracic Surgery
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will compare atorvastatin Lipitor with a placebo inactive pill to see if this drug reduces heart rhythm abnormalities arrhythmias or lung inflammation after thoracic surgery Preliminary results suggest that cholesterol lowering drugs statins may reduce problems after surgery such as arrhythmias or lung inflammation which may be serious This study will be randomized and double blind meaning that patients are placed in groups purely by chance like flipping a coin Neither the patient or doctor will know which group the patient is in
Detailed Description:
Hypothesis Statins attenuate perioperative inflammatory and oxidative mechanisms that contribute to the initiation and severity of cardiopulmonary complications after thoracic surgery
Aim 1 To determine whether prophylactic administration of atorvastatin attenuates the inflammatory and oxidative response to surgery and significantly reduces the composite risk of cardiovascular morbidity atrial fibrillation AF acute coronary syndrome myocardial infarction MI cerebrovascular accident CVA pulmonary embolism and mortality within 30 days after thoracic surgery
Aim 2 To explore whether prophylactic administration of atorvastatin attenuates the inflammatory and oxidative CRP IL-6 TNF and MPO response to surgery and significantly reduces the overall risk of pulmonary complications atelectasis pneumonia pneumonitis acute respiratory failure after thoracic surgery
Aim 3 To explore the association of single nucleotide polymorphism SNP changes in genes linked to atrial fibrillation and inflammatory markers and development of pulmonary morbidity after thoracic surgery
Aim 4 To explore whether an imbalance between metalloproteinase MMP-1 and its inhibitor TIMP is associated with postoperative atrial fibrillation risk andor development of pulmonary morbidity after thoracic surgery
Aim 1 To determine whether prophylactic administration of atorvastatin attenuates the inflammatory and oxidative response to surgery and significantly reduces the composite risk of cardiovascular morbidity atrial fibrillation AF acute coronary syndrome myocardial infarction MI cerebrovascular accident CVA pulmonary embolism and mortality within 30 days after thoracic surgery
Aim 2 To explore whether prophylactic administration of atorvastatin attenuates the inflammatory and oxidative CRP IL-6 TNF and MPO response to surgery and significantly reduces the overall risk of pulmonary complications atelectasis pneumonia pneumonitis acute respiratory failure after thoracic surgery
Aim 3 To explore the association of single nucleotide polymorphism SNP changes in genes linked to atrial fibrillation and inflammatory markers and development of pulmonary morbidity after thoracic surgery
Aim 4 To explore whether an imbalance between metalloproteinase MMP-1 and its inhibitor TIMP is associated with postoperative atrial fibrillation risk andor development of pulmonary morbidity after thoracic surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
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