Ignite Creation Date:
2024-05-06 @ 1:52 PM
Last Modification Date:
2024-10-26 @ 1:21 PM
Study NCT ID:
NCT04154982
Status:
RECRUITING
Last Update Posted:
2023-08-02
First Post:
2019-10-17
Brief Title:
N-Acetylcysteine Protection Against Radiation Induced Cellular Damage
Sponsor:
Centro Cardiologico Monzino
Organization:
Centro Cardiologico Monzino
Study Overview
Official Title:
Cardiac Arrhythmia Catheter Ablation Procedures Guided by x-Ray Imaging N-Acetylcysteine Protection Against Radiation Induced Cellular damagE CARAPACE Study
Status:
RECRUITING
Status Verified Date:
2023-08
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:
CARAPACE
Brief Summary:
Catheter ablation procedures CAPs are first line treatment for a great variety of cardiac arrhythmias CAPs require X-Ray imaging consequently CAPs cause ionizing radiation IR exposure for patients Exposure to IR even at low-doses increases individual risk of developing cancer IR cause DNA damage directly and mostly indirectly by formation of cellular free radicals Furthermore different response to IR results from inherited variants in genes involved in DNA damage repair N-acetylcysteine NAC is an aminoacid that can directly neutralize free radicals and increase antioxidant systems Our preliminary data suggest that IR exposure in patients undergoing CAP deranges the oxidative stress status and the pre-procedure intravenous administration of NAC could decrease such abnormality
Detailed Description:
CARAPACE is a prospective randomized single-blinded parallel-arm monocenter study Eligible patients undergoing CAP at the Arrhythmology Unit of Centro Cardiologico Monzino will be enrolled
The hypothesis driving our study based on published literature and our preliminary data is that administration of antioxidant agents before cardiac procedures involving IR exposure might prevent IR harmful effects on human tissues in terms of reduction of systemic oxidative stress status and in parallel of oxidative DNA damage
The antioxidant agent tested in our study is NAC NAC is a well-tolerated and safe medication and it has antioxidant properties is based on three main mechanisms 1 direct antioxidant effect 2 glutathione GSH precursor action and 3 its activity in breaking thiolated proteins
Another hypothesis to be tested is whether genes involved in DNA damage repair could explain the great variability in patient radiosensitivity to IR exposure and whether these genes could affect NAC protectivehealing effects
The hypothesis driving our study based on published literature and our preliminary data is that administration of antioxidant agents before cardiac procedures involving IR exposure might prevent IR harmful effects on human tissues in terms of reduction of systemic oxidative stress status and in parallel of oxidative DNA damage
The antioxidant agent tested in our study is NAC NAC is a well-tolerated and safe medication and it has antioxidant properties is based on three main mechanisms 1 direct antioxidant effect 2 glutathione GSH precursor action and 3 its activity in breaking thiolated proteins
Another hypothesis to be tested is whether genes involved in DNA damage repair could explain the great variability in patient radiosensitivity to IR exposure and whether these genes could affect NAC protectivehealing effects
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?:
None