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

Cardiac Arrhythmia catheter ablation procedures guided by x-Ray imaging: N-Acetylcysteine Protection Against radiation induced Cellular damagE (CARAPACE Study). - CARAPACE

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001995-12-IT

Enrollment

550

Registered

2021-06-17

Start date

2019-09-27

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with Cardiac Arrhythmia who undergo catheter ablation procedures guided by x-Ray imaging MedDRA version: 23.1 Level: LLT Classification code 10007518 Term: Cardiac arrhythmia System Organ Class: 100000004849

Interventions

Trade Name: ACETILCISTEINA EG - 300 MG/3 ML SOLUZIONE INIETTABILE E DA NEBULIZZARE 5 FIALE Product Name: ACETILCISTEINA EG Product Code: [ACETILCISTEINA EG] Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Countries

Italy

Contacts

Public ContactUFFICIO STUDI CLINICI E ATTIVITà RE

ISTITUTO EUROPEO ONCOLOGIA

ufficio.studiclinici@ieo.it0257489848

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026