N-Acetylcysteine Protection Against Radiation Induced Cellular Damage (CARAPACE)
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ClinicalTrials.gov Identifier: NCT04154982 |
Recruitment Status :
Recruiting
First Posted : November 7, 2019
Last Update Posted : August 2, 2023
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Condition or disease | Intervention/treatment | Phase |
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Cardiac Arrhythmia | Drug: Acetyl cysteine | Phase 2 |
CARAPACE is a prospective, randomized, single-blinded, parallel-arm monocenter study. Eligible patients undergoing CAP at the Arrhythmology Unit of Centro Cardiologico Monzino will be enrolled.
The hypothesis driving our study, based on published literature and our preliminary data, is that administration of antioxidant agents, before cardiac procedures involving IR exposure, might prevent IR harmful effects on human tissues in terms of reduction of systemic oxidative stress status and, in parallel, of oxidative DNA damage.
The antioxidant agent tested in our study is NAC. NAC is a well-tolerated and safe medication and it has antioxidant properties is based on three main mechanisms: 1) direct antioxidant effect, 2) glutathione (GSH) precursor action, and 3) its activity in breaking thiolated proteins.
Another hypothesis to be tested is whether genes involved in DNA damage repair could explain the great variability in patient radiosensitivity to IR exposure and whether these genes could affect NAC protective/healing effects.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 550 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Masking Description: | Researchers, involved in the assessment of NAC efficacy, are blinded to randomization process; thus, they do not know whether the patients are in the NAC or in the control groups. |
Primary Purpose: | Treatment |
Official Title: | Cardiac Arrhythmia Catheter Ablation Procedures Guided by x-Ray Imaging: N-Acetylcysteine Protection Against Radiation Induced Cellular damagE (CARAPACE Study) |
Actual Study Start Date : | September 2, 2020 |
Estimated Primary Completion Date : | December 1, 2024 |
Estimated Study Completion Date : | December 1, 2024 |
Arm | Intervention/treatment |
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Experimental: Pharmacological treatment
Patients are treated with NAC prior to carrying out CAP.
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Drug: Acetyl cysteine
1200 mg of NAC are intravenously administrated 1 hour prior to carrying out CAP. |
No Intervention: Standard procedure
Patients are not treated with NAC. No placebo treatment is performed.
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- Measurement of change in systemic oxidative stress (ratio between GSH oxidized form (GSSG) and GSH, 8-iso-prostaglandinF2α (8-iso-PGF2α) and 8-hydroxy-2-deoxyguanosine (8-OHdG)) and genomic DNA oxidative damage (percentage of DNA present in the tails). [ Time Frame: 48 hours ]Measurement of change in systemic oxidative stress (GSSG/GSH, 8-iso-PGF2α and 8-OHdG) and genomic DNA oxidative damage (% DNA present in the tails of the comet assay) between the two groups (NAC versus no NAC) at the different time-points (T0 = before CAP, T1 = 3h after CAP, T2 = 24h after CAP, T3 = 48h after CAP).
- Measurement of change in systemic oxidative stress (GSSG/GSH, 8-iso-PGF2α and 8-OHdG) and genomic DNA oxidative damage (% DNA present in the tails) related to IR dose (fluoroscopy time (FT), Dose Area Product (DAP) and effective dose (ED)). [ Time Frame: 48 hours ]Measurement of change in systemic oxidative stress (GSSG/GSH, 8-iso-PGF2α and 8-OHdG) and genomic DNA oxidative damage (% DNA present in the tails) related to IR dose (FT, DAP and ED) between the two groups (NAC versus no NAC).
- Measurement of change in genomic DNA oxidative damage (% DNA present in the tails) related to IR dose (FT, DAP and ED) and inherited variants in genes involved in DNA damage repair. [ Time Frame: 48 hours ]Measurement of change in genomic DNA oxidative damage (% DNA present in the tails) related to IR dose (FT, DAP and ED) and inherited variants in genes involved in DNA damage repair between the two groups (NAC versus no NAC).
- Measurement of change in the response to NAC administration related to inherited variants in genes involved in DNA damage repair. [ Time Frame: 48 hours ]
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04154982
Contact: Claudio Tondo | +39025800 ext 2480 | claudio.tondo@ccfm.it | |
Contact: Valentina Catto | +39025800 ext 2856 | valentina.catto@ccfm.it |
Italy | |
Centro Cardiologico Monzino | Recruiting |
Milano, MI, Italy, 20138 |
Publications:
Responsible Party: | Claudio Tondo, Deputy of Heart Rhythm Center, Centro Cardiologico Monzino |
ClinicalTrials.gov Identifier: | NCT04154982 |
Other Study ID Numbers: |
CCM1006 |
First Posted: | November 7, 2019 Key Record Dates |
Last Update Posted: | August 2, 2023 |
Last Verified: | August 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Electrophysiology Arrhythmias Arrhythmia ablation |
Ionizing radiation risk Oxidative stress DNA damage biomarkers |
Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Acetylcysteine N-monoacetylcystine Antiviral Agents Anti-Infective Agents |
Expectorants Respiratory System Agents Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Antidotes |