Ignite Creation Date:
2024-05-06 @ 7:10 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05913362
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-06-22
First Post:
2023-06-13
Brief Title:
IVUS Guided PCI for CKD to Reduce CI-AKI
Sponsor:
Jilin University
Organization:
Jilin University
Study Overview
Official Title:
IVUS Based Ultra-low Volume Contrast Media PCI to Reduce Contrast Induced Nephrology in Patient With Chronic Kidney disease-a Multi-center Open Label Randomized Trial IVUS-CKD
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-06
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:
IVUS-CKD
Brief Summary:
Patients with Chronic kidney disease are most vulnerable to contrast induced nephropathy after Percutaneous coronary intervention intravascular ultrasound guidance can be used to safely guide the procedure to reduce the contrast usage this randomized trial is design to test the hypothesis that IVUS based ultra-low contrast PCI is feasible and can reduce the contrast induced nephropathy
Detailed Description:
Prospective open-label randomized11 multi-center trial of 320 patients allocated to one of the treatment armsIVUS-guided ultra-low contrast PCI or angiography-guided PCI
The study population will be composed of patients with renal dysfunction referring for PCI on one to more coronary artery target lesion must be assessable with IVUS
eGFR will be re-evaluated 48 hours after the procedure and at 1 month 3 month 6 month 12 month as well as follow-up for other clinical outcomes unless contra-indicated all patients will receive intravenous hydration 12 hours before and after the procedure saline infusion at a dose of 1mlkghour if with reduced ejection fraction or overt heart failure reduce the saline infusion to 05mlkghour the use of sodium bicarbonate and diuretic will be left at the discretion of the operator All procedure will be performed using non-ionic low osmolar or iso-osmolar iodine-based contrast media the study groups will be compared according to the intention-to-treat principle Categorial variables will be compared by Fishers exact test and continuous variables by students T test Time-dependent events will be estimated by the Kaplan-Meier method and compared by hazards cox model or log-rank test
The study population will be composed of patients with renal dysfunction referring for PCI on one to more coronary artery target lesion must be assessable with IVUS
eGFR will be re-evaluated 48 hours after the procedure and at 1 month 3 month 6 month 12 month as well as follow-up for other clinical outcomes unless contra-indicated all patients will receive intravenous hydration 12 hours before and after the procedure saline infusion at a dose of 1mlkghour if with reduced ejection fraction or overt heart failure reduce the saline infusion to 05mlkghour the use of sodium bicarbonate and diuretic will be left at the discretion of the operator All procedure will be performed using non-ionic low osmolar or iso-osmolar iodine-based contrast media the study groups will be compared according to the intention-to-treat principle Categorial variables will be compared by Fishers exact test and continuous variables by students T test Time-dependent events will be estimated by the Kaplan-Meier method and compared by hazards cox model or log-rank test
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