E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with Cardiac Arrhythmia who undergo catheter ablation procedures guided by x-Ray imaging |
Pazienti con aritmia cardiaca candidati a trattamento con procedura di ablazione transcatetere, guidata da raggi X. |
|
E.1.1.1 | Medical condition in easily understood language |
Patients with Cardiac Arrhythmia who undergo catheter ablation procedures guided by x-Ray imaging |
Pazienti con aritmia cardiaca candidati a trattamento con procedura di ablazione transcatetere, guidata da raggi X. |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10007518 |
E.1.2 | Term | Cardiac arrhythmia |
E.1.2 | System Organ Class | 100000004849 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
L’obiettivo principale dello studio CARAPACE è di valutare se la somministrazione di N-acetilcisteina prima della procedura di ablazione possa prevenire l’aumento di stress ossidativo a livello sistemico ed il conseguente danno ossidativo a livello del DNA. |
|
E.2.2 | Secondary objectives of the trial |
The secondary objective is to study the role of genetic variants involved in DNA damage repair. |
L’obiettivo secondario riguarda lo studio del ruolo delle varianti genetiche coinvolte nella riparazione del danno del DNA. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
Età >18 anni. Indicazione a eseguire ablazione transcatetere guidata da fluoroscopia. Test di gravidanza sierologico negativo (se appropriato). Capacità e volontà di fornire il consenso informato e di attenersi al protocollo. |
|
E.4 | Principal 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. |
Controindicazione all’ablazione transcatetere (per esempio, gravidanza e allattamento). Ipersensibilità al principio attivo o ad uno qualsiasi degli eccipienti. Arruolamento in un altro studio che potrebbe interferire con CARAPACE. Somministrazione di un farmaco sperimentale entro 30 giorni o entro 5 emivite del farmaco in studio Malattia renale cronica (creatinina sierica >1.5 mg/dl). Malattia infiammatoria in fase acuta/cronica. Assunzione di farmaci antiossidanti nelle 2 settimane precedenti. Storia di radioterapia o chemioterapia nell’ultimo anno. Qualsiasi condizione documentata che, a giudizio dello sperimentatore principale, renda il paziente non candidabile allo studio. Esecuzione di TAC e/o coronarografia nei 5 giorni precedenti l’analisi basale. |
|
E.5 End points |
E.5.1 | 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. |
Valutazione dell’efficacia del trattamento pre-ablazione con NAC tramite l’analisi dei valori di GSSG/GSH, 8-iso-PGF2a, 8-OHdG e percentuale di DNA presente nelle code del comet assay, confrontando i due gruppi (NAC versus no NAC) a diversi time-point |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
pre-procedure, 3-24-48 h after procedure. |
pre-ablazione, 3, 24 e 48 ore post-ablazione. |
|
E.5.2 | Secondary end point(s) |
role of genetic variants involved in DNA damage repair. |
ruolo delle varianti genetiche coinvolte nella riparazione del danno del DNA. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
end of the study. |
fine studio |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
saranno tenuti in condizioni di cecità i valutatori dei test relati all'obiettivo primario |
single blind condition will be applied to people involved in the tests related to the primaty end-po |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
pazienti sottoposti a procedura di ablazione che non ricevono il farmaco |
patients undergoing ablation procedure that are not treated with the drug |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |