Protection offered by N-Acetylcysteine against radiation induced cellular damage in patients undergoing ablation procedures because of cardiac arrhythmia.

Phase 1

• Conditions: Patients with Cardiac Arrhythmia who undergo catheter ablation procedures guided by x-Ray imaging; MedDRA version: 23.1Level: LLTClassification code 10007518Term: Cardiac arrhythmiaSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2019-001995-12-IT
• Lead Sponsor: CENTRO CARDIOLOGICO SPA FONDAZIONE MONZINO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-17
• Last Update Posted: 10 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 550

Inclusion Criteria

Patient’s age >18 years.
Indication to perform catheter ablation procedure guided by fluoroscopy (IR imaging).
Negative hCG pregnancy test (if appropriate).
Ability and willingness to give informed consent and to comply with protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 275
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 275

Exclusion Criteria

Any contraindication to Catheter Ablation Procedure (such as, pregnancy and breastfeeding).
Hypersensitivity to the active substance or to any of the excipients.
Enrolment 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of the CARAPACE study is to evaluate whether the administration of N-acetyl-cysteine before the ablation procedure can prevent the increase of oxidative stress at the systemic level and the consequent oxidative damage at the DNA level.;Secondary Objective: The secondary objective is to study the role of genetic variants involved in DNA damage repair.;Primary end point(s): To investigate whether administration of NAC before CAP could prevent the IR induced systemic oxidative stress and genomic DNA oxidative damage. In particular, the investigators will compare GSSG/GSH, 8-iso-PGF2a, 8-OHdG, and percentage of DNA present in the tails of the comet assay between the two groups (NAC versus no NAC) at the different time-points.;Timepoint(s) of evaluation of this end point: pre-procedure, 3-24-48 h after procedure.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): role of genetic variants involved in DNA damage repair.;Timepoint(s) of evaluation of this end point: end of the study.