Official Title
Cardiac Arrhythmia Catheter Ablation Procedures Guided by x-Ray Imaging: N-Acetylcysteine Protection Against Radiation Induced Cellular damagE (CARAPACE Study)
Brief Title
N-Acetylcysteine Protection Against Radiation Induced Cellular Damage
Protocol ID
NCT04154982
Lead Sponsor
Centro Cardiologico Monzino
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 protective/healing effects.
Study Period
-
Enrollment Count
181 participants
Eligibility Criteria
Inclusion Criteria:
- Patient's age >18 years.
- Negative hCG pregnancy test (if appropriate).
- Indication to perform CAP guided by fluoroscopy (IR imaging).
- Ability and willingness to give informed consent and to comply with protocol.
Exclusion Criteria:
- Any contraindication to CAP (such as, pregnancy and breastfeeding).
- Hypersensitivity to the active substance or to any of the excipients.
- Enrollment in another study that may interfere with CARAPACE study.
- Administration of an experimental drug within 30 days or 5 half-lives of the
investigational drug.
- Chronic kidney disease (serum creatinine >1.5 mg/dl).
- Acute/Chronic inflammatory disease.
- Antioxidant drugs intake over the previous 2 weeks.
- History of radiotherapy or chemotherapy in the last year.
- Any documented condition that, in PI's motivated judgement, makes the patient a poor
candidate for the study.
- Computed tomography and/or coronary angiography within 5 days prior to baseline
analysis.
Filters
Cardiac Arrhythmia
PHASE2
COMPLETED
ADULT
OLDER_ADULT