Ignite Creation Date:
2025-12-24 @ 3:52 PM
Ignite Modification Date:
2025-12-26 @ 8:59 PM
Study NCT ID:
NCT04928092
Status:
WITHDRAWN
Last Update Posted:
2022-02-04
First Post:
2021-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Zero Acute Kidney Injury Strategy for Percutaneous Coronary Intervention in Patients With ChronicKidney Disease
Sponsor:
Virginia Commonwealth University
Organization:
Study Overview
Official Title:
A Zero Acute Kidney Injury (Zero-AKI) Strategy for Percutaneous Coronary Intervention in Patients With ChronicKidney Disease
Status:
WITHDRAWN
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The PI is leaving the institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Zero-AKI
Brief Summary:
The purpose of this study is to compare the outcomes of Percutaneous Coronary Intervention (PCI) in patients with chronic kidney disease (CKD) using smaller doses of contrast dye that are validated as being at low risk of causing injury to the kidneys, with the larger doses that are traditionally used contemporary practice.
Detailed Description:
This study will evaluate whether using lower doses of contrast dye leads to lower rates of kidney injury compared to current standard of care. In particular, effort will be taken to maintain the total amount of contrast dye below a scientifically-validated threshold calculated on the basis of each participant renal function. Participants will already be scheduled to undergo a PCI. Because a smaller amount of contrast dye will be used, an intravascular ultrasound (IVUS) will be used to help the doctors see and open the blockages in participant's coronary arteries. IVUS is already used to optimize PCI results, but will be used more extensively in this case. The amount of contrast dye received will be tailored on each participant kidney function. Prospectively enrolled patients will be matched with historical controls who underwent PCI with non-intravascular imaging based approach.
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?:
None
Is an FDA AA801 Violation?: