Ignite Creation Date:
2024-05-06 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05775380
Status:
RECRUITING
Last Update Posted:
2024-01-12
First Post:
2023-03-07
Brief Title:
The Role of Pioglitazone in Vascular Transcriptional Remodeling
Sponsor:
University of Campinas Brazil
Organization:
University of Campinas Brazil
Study Overview
Official Title:
The Role of Pioglitazone in Vascular Transcriptional Remodeling in Individuals Undergoing Coronary Artery Bypass Grafting
Status:
RECRUITING
Status Verified Date:
2024-01
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:
PREVALENT
Brief Summary:
Acute myocardial infarction AMI remains the leading cause of death worldwide In this scenario early coronary reperfusion is the main therapeutic strategy as it substantially reduces mortality Paradoxically however reperfusion triggers additional tissue damage that accounts for about 50 of the infarcted heart mass ie ischemia and reperfusion injury IRL In this context sphingosine-1-phosphate S1P is a sphingolipid synthesized by sphingosine kinases Sphk carried in plasma bound to high-density lipoprotein HDL and released after cellular damage such as LIR Particularly in animal models of AMI therapies targeting downstream S1P receptor signaling triggered by HDLS1P are able to promote endothelial barrier functions and attenuate secondary damage to LIR Thus the molecular control of sphingosine kinase 1 Sphk1 transcription during LIR in vivo or during hypoxiareoxygenation HR in vitro may represent an important mechanism for maintaining endothelial homeostasis since it promotes the generation of S1P and this may promote subsequent HDL enrichment Thus the role of pioglitazone hydrochloride 45mgday for five days in volunteers undergoing coronary artery bypass grafting BVR will be investigated in order to verify the vascular expression of SPhk1 transcriptome and vascular proteome remodeling as well as S1P content in HDL
Detailed Description:
This will be a prospective randomized and open clinical study From a sample of patients hospitalized for myocardial revascularization surgery followed at the cardiac surgery outpatient clinic 20 research participants male aged over 40 years non-diabetic or diabetic with disease duration of less than 10 years glycated hemoglobin 8 and non-user of NPH insulin body mass index BMI between 20 and 349kgm2 and glomerular filtration rate above 45mLmin who will be monitored at the Hospital de ClínicasUNICAMP and randomized to receive pioglitazone hydrochloride 45mgday for 5 days before surgery The amount of S1P in HDL at baseline before surgery will be assessed This same measurement will be repeated on day 5 coinciding with the day of surgery after using pioglitazone hydrochloride 45mgday In addition on the day of surgery a saphenous vein fragment of approximately 2 cm and an internal thoracic artery fragment of approximately 1 cm will be collected which will not impair the quality of the graft nor the extent of the material to be used as a graft because in this case the vascular material is abundant An aortic artery button and an atrial appendage button will also be collected which will be discarded In addition the results of serum troponin levels in the first 24h post-SVR 6 12 24h will be evaluated to estimate the extent of troponin release Postoperative examination
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None