CompletedPhase 2

N-Acetylcysteine Protection Against Radiation Induced Cellular Damage

Italy181 participantsStarted 2020-09-02

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Measurement of change in systemic oxidative stress (ratio between GSH oxidized form (GSSG) and GSH, 8-iso-prostaglandinF2α (8-iso-PGF2α) and 8-hydroxy-2-deoxyguanosine (8-OHdG)) and genomic DNA oxidative damage (percentage of DNA present in the tails).

Timeframe: 48 hours

Trial details

NCT IDNCT04154982

SponsorCentro Cardiologico Monzino

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-02