Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00351247
Status:
UNKNOWN
Last Update Posted:
2006-07-12
First Post:
2006-07-11
Brief Title:
Postconditioning in Primary PCI and Direct Stenting
Sponsor:
Sheba Medical Center
Organization:
Sheba Medical Center
Study Overview
Official Title:
Clinical and MRI Evaluation of 2 Vs 4 Cycles of Postconditioning During Primary PCI With Direct Stenting
Status:
UNKNOWN
Status Verified Date:
2006-07
Last Known Status:
NOT_YET_RECRUITING
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:
To determine the safety and efficacy of 2 vs 4 cycles of postconditioning method during primary PCI and direct stenting in acute MI and to compared to primary PCI and direct stenting without the postconditioning
Detailed Description:
Sample size 45 subjects
Site Locations Sheba medical center
Patients Patients presenting with an acute MI with onset of symptoms 6h and planned to undergo primary PCI will be included The target lesion should be located in the proximal or middle segment of a main native coronary artery and should be suitable for percutaneous intervention
Primary Objective To determine the safety and efficacy of 2 vs 4 cycles of postconditioning method during primary PCI and direct stenting in acute MI and to compared to primary PCI and direct stenting without the postconditioning
Primary Endpoint
ST segment resolution
Segmental wall motion score resolution of edema and wall thickness by echocardiography
Infarct size estimation by cardiac enzymes and cardiac MRI
Secondary endpoints
Composite endpoint of Major Adverse Cardiac Events MACE at 30 and 90 days
Methods
ECG at baseline immediately after procedure 90 and 180 minutes after the procedure and 6-24 hours after intervention
Core laboratory angiography measurements of TIMI flow corrected TIMI Frame count myocardial blush score and left ventricular angiography
Myocardial enzymes measurements every 4 hours in the first 24 hours and every 6 hours in the following 48 hours
Left ventricular ejection fraction and wall motion score determined by echocardiography
Cardiac MRI estimation of infarct size Clinical follow-up at 30 and 90 days post procedure
Follow-up
Follow up at 30 days Clinical
Clinical Follow up Cardiac MRI at 90 days
Site Locations Sheba medical center
Patients Patients presenting with an acute MI with onset of symptoms 6h and planned to undergo primary PCI will be included The target lesion should be located in the proximal or middle segment of a main native coronary artery and should be suitable for percutaneous intervention
Primary Objective To determine the safety and efficacy of 2 vs 4 cycles of postconditioning method during primary PCI and direct stenting in acute MI and to compared to primary PCI and direct stenting without the postconditioning
Primary Endpoint
ST segment resolution
Segmental wall motion score resolution of edema and wall thickness by echocardiography
Infarct size estimation by cardiac enzymes and cardiac MRI
Secondary endpoints
Composite endpoint of Major Adverse Cardiac Events MACE at 30 and 90 days
Methods
ECG at baseline immediately after procedure 90 and 180 minutes after the procedure and 6-24 hours after intervention
Core laboratory angiography measurements of TIMI flow corrected TIMI Frame count myocardial blush score and left ventricular angiography
Myocardial enzymes measurements every 4 hours in the first 24 hours and every 6 hours in the following 48 hours
Left ventricular ejection fraction and wall motion score determined by echocardiography
Cardiac MRI estimation of infarct size Clinical follow-up at 30 and 90 days post procedure
Follow-up
Follow up at 30 days Clinical
Clinical Follow up Cardiac MRI at 90 days
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