Using N-Acetylcysteine to Protect Against Radiation Damage During Heart Procedures
Cardiac Arrhythmia Catheter Ablation Procedures Guided by x-Ray Imaging: N-Acetylcysteine Protection Against Radiation Induced Cellular damagE (CARAPACE Study)
PHASE2 · Centro Cardiologico Monzino · NCT04154982
This study is testing if giving N-acetylcysteine before heart procedures can help protect patients from radiation damage.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 550 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centro Cardiologico Monzino (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Milano, MI) |
| Trial ID | NCT04154982 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of N-acetylcysteine (NAC), an antioxidant, to reduce oxidative stress and DNA damage caused by ionizing radiation during catheter ablation procedures for cardiac arrhythmias. It is a prospective, randomized, single-blinded, parallel-arm study conducted at the Arrhythmology Unit of Centro Cardiologico Monzino. The study aims to determine if pre-procedure administration of NAC can mitigate the harmful effects of radiation exposure and whether genetic factors influence individual responses to radiation and NAC treatment.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who require catheter ablation guided by fluoroscopy.
Not a fit: Patients with contraindications to catheter ablation, chronic kidney disease, or those who have recently undergone radiotherapy or chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of radiation-induced damage in patients undergoing cardiac procedures.
How similar studies have performed: While the use of antioxidants in radiation protection is a well-explored area, this specific application of NAC in cardiac procedures is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Milano, MI
- Centro Cardiologico Monzino — Milano, MI, Italy (RECRUITING)
Study contacts
- Study coordinator: Claudio Tondo
- Email: claudio.tondo@ccfm.it
- Phone: +39025800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cardiac Arrhythmia, Electrophysiology, Arrhythmias, Arrhythmia ablation, Ionizing radiation risk, Oxidative stress, DNA damage biomarkers