EUCTR2019-001995-12-IT
Active, not recruiting
Phase 1
Cardiac Arrhythmia catheter ablation procedures guided by x-Ray imaging: N-Acetylcysteine Protection Against radiation induced Cellular damagE (CARAPACE Study). - CARAPACE
CENTRO CARDIOLOGICO SPA FONDAZIONE MONZINO0 sites550 target enrollmentJune 17, 2021
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients with Cardiac Arrhythmia who undergo catheter ablation procedures guided by x-Ray imaging
- Sponsor
- CENTRO CARDIOLOGICO SPA FONDAZIONE MONZINO
- Enrollment
- 550
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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