Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06564909
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-16
Brief Title:
Effect of L-Carnitine on Biomarkers of Myocardial Reperfusion Injury in Patients With STEMI
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of L-Carnitine on Biomarkers of Myocardial Reperfusion Injury in Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study aims is to evaluate the efficacy and tolerability of L-Carnitine on biomarkers of myocardial reperfusion injury in patients with ST-segment elevation myocardial infarction STEMI undergoing primary PCI by the assessment of nitrotyrosine as an oxidative stress marker and Matrix metallopeptidase-2 MMP-2 as a cardiac fibrosis marker
Detailed Description:
This study aims to investigate the effects of L-Carnitine on biomarkers of myocardial reperfusion injury in patients with ST-segment elevation myocardial infarction STEMI undergoing primary PCI by the assessment of the following
1 Measurement of nitrotyrosine as an oxidative stress marker and Matrix metallopeptidase-2 MMP-2 as a cardiac fibrosis marker
2 Assessment of The TIMI thrombolysis in myocardial infarction grade and Myocardial Blush Grade MBG
3 Echocardiography parameters
Patients and Methods
Design Prospective randomized open label controlled clinical trial
Patients A total of 76 STEMI patients undergoing primary PCI will be enrolled in the study and will be randomly assigned into one of 2 arms
Group 1 Control group n38 STEMI patients undergoing PCI who will receive the standard of care Group 2 Test group n 38 STEMI patients undergoing PCI who will receive the standard of care in addition to L-Carnitine 5 g intravenous administered as slow Iv push over 2-3 minutes L-Carnitine 1 gm 5 mL Injection MEPACO Egypt prior to PCI and then 2 g orally Carnitol 500 mg Global Napi Egypt daily for 4 weeks after PCI
1 Measurement of nitrotyrosine as an oxidative stress marker and Matrix metallopeptidase-2 MMP-2 as a cardiac fibrosis marker
2 Assessment of The TIMI thrombolysis in myocardial infarction grade and Myocardial Blush Grade MBG
3 Echocardiography parameters
Patients and Methods
Design Prospective randomized open label controlled clinical trial
Patients A total of 76 STEMI patients undergoing primary PCI will be enrolled in the study and will be randomly assigned into one of 2 arms
Group 1 Control group n38 STEMI patients undergoing PCI who will receive the standard of care Group 2 Test group n 38 STEMI patients undergoing PCI who will receive the standard of care in addition to L-Carnitine 5 g intravenous administered as slow Iv push over 2-3 minutes L-Carnitine 1 gm 5 mL Injection MEPACO Egypt prior to PCI and then 2 g orally Carnitol 500 mg Global Napi Egypt daily for 4 weeks after PCI
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