Cardiac ArrhythmiaPhase 2CARAPACENCT04154982
N-Acetylcysteine Protection Against Radiation Induced Cellular Damage
A Phase 2 study testing Acetyl cysteine in people with Cardiac Arrhythmia, run by Centro Cardiologico Monzino at 1 site in Italy.
Trial summary
Catheter ablation procedures (CAPs) are first line treatment for a great variety of cardiac arrhythmias. CAPs require X-Ray imaging; consequently, CAPs cause ionizing radiation (IR) exposure for patients. Exposure to IR, even at low-doses, increases individual risk of developing cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrhythmia
- What is being tested?
- Acetyl cysteine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 1 siteItaly
- Study dates
- 2 Sep 2020to 2 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiac Arrhythmia Catheter Ablation Procedures Guided by x-Ray Imaging: N-Acetylcysteine Protection Against Radiation Induced Cellular damagE (CARAPACE Study)
Catheter ablation procedures (CAPs) are first line treatment for a great variety of cardiac arrhythmias. CAPs require X-Ray imaging; consequently, CAPs cause ionizing radiation (IR) exposure for patients. Exposure to IR, even at low-doses, increases individual risk of developing cancer. IR cause DNA damage directly and, mostly, indirectly by formation of cellular free radicals. Furthermore different response to IR results from inherited variants in genes involved in DNA damage repair. N-acetylcysteine (NAC) is an aminoacid that can directly neutralize free radicals and increase antioxidant systems. Our preliminary data suggest that IR exposure in patients undergoing CAP deranges the oxidative stress status and the pre-procedure intravenous administration of NAC could decrease such abnormality.
Read the detailed description
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.
- Conditions
- Cardiac Arrhythmia
- Being tested
- Acetyl cysteine
- Keywords
- Electrophysiology, Arrhythmias, Arrhythmia ablation, Ionizing radiation risk, Oxidative stress, DNA damage biomarkers
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetyl cysteineDrug
1200 mg of NAC are intravenously administrated 1 hour prior to carrying out CAP.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacological treatment | Experimental | Patients are treated with NAC prior to carrying out CAP. Receives: Drug: Acetyl cysteine |
| Standard procedure | No intervention | Patients are not treated with NAC. No placebo treatment is performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
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).
Measured: 48 hours
Secondary outcomes (3)
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)).
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).
Measured: 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.
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).
Measured: 48 hours
Measurement of change in the response to NAC administration related to inherited variants in genes involved in DNA damage repair.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start2 Sep 2020
- Primary completion2 Dec 2024
- Study completion2 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Cardiologico Monzino
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Italy
- Responsible party
- Principal investigator, Claudio Tondo, Centro Cardiologico Monzino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04154982
- Sponsor's protocol ID
- CCM1006
- Acronym
- CARAPACE
- Status last verified
- Aug 2025
- First submitted
- 17 Oct 2019
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Turnu L, Porro B, Alfieri V, Di Minno A, Russo E, Barbieri S, Bonomi A, Dello Russo A, Tondo C, D'Alessandra Y, Cavalca V, Tremoli E, Colombo GI, Casella M. Does Fluoroscopy Induce DNA Oxidative Damage in Patients Undergoing Catheter Ablation? Antioxid Redox Signal. 2018 Apr 20;28(12):1137-1143. doi: 10.1089/ars.2017.7334. Epub 2017 Nov 27.
PubMed 28938845Heidbuchel H, Wittkampf FH, Vano E, Ernst S, Schilling R, Picano E, Mont L, Jais P, de Bono J, Piorkowski C, Saad E, Femenia F. Practical ways to reduce radiation dose for patients and staff during device implantations and electrophysiological procedures. Europace. 2014 Jul;16(7):946-64. doi: 10.1093/europace/eut409. Epub 2014 May 2.
PubMed 24792380Evans MD, Dizdaroglu M, Cooke MS. Oxidative DNA damage and disease: induction, repair and significance. Mutat Res. 2004 Sep;567(1):1-61. doi: 10.1016/j.mrrev.2003.11.001.
PubMed 15341901Andreassi MG, Foffa I, Manfredi S, Botto N, Cioppa A, Picano E. Genetic polymorphisms in XRCC1, OGG1, APE1 and XRCC3 DNA repair genes, ionizing radiation exposure and chromosomal DNA damage in interventional cardiologists. Mutat Res. 2009 Jun 18;666(1-2):57-63. doi: 10.1016/j.mrfmmm.2009.04.003. Epub 2009 Apr 22.
PubMed 19393248Huang A, Glick SA. Genetic susceptibility to cutaneous radiation injury. Arch Dermatol Res. 2017 Jan;309(1):1-10. doi: 10.1007/s00403-016-1702-3. Epub 2016 Nov 22.
PubMed 27878387Cervelli T, Panetta D, Navarra T, Gadhiri S, Salvadori P, Galli A, Caramella D, Basta G, Picano E, Del Turco S. A New Natural Antioxidant Mixture Protects against Oxidative and DNA Damage in Endothelial Cell Exposed to Low-Dose Irradiation. Oxid Med Cell Longev. 2017;2017:9085947. doi: 10.1155/2017/9085947. Epub 2017 Aug 9.
PubMed 28852434Aldini G, Altomare A, Baron G, Vistoli G, Carini M, Borsani L, Sergio F. N-Acetylcysteine as an antioxidant and disulphide breaking agent: the reasons why. Free Radic Res. 2018 Jul;52(7):751-762. doi: 10.1080/10715762.2018.1468564. Epub 2018 May 9.
PubMed 29742938Mu H, Sun J, Li L, Yin J, Hu N, Zhao W, Ding D, Yi L. Ionizing radiation exposure: hazards, prevention, and biomarker screening. Environ Sci Pollut Res Int. 2018 Jun;25(16):15294-15306. doi: 10.1007/s11356-018-2097-9. Epub 2018 Apr 29.
PubMed 29705904Squellerio I, Caruso D, Porro B, Veglia F, Tremoli E, Cavalca V. Direct glutathione quantification in human blood by LC-MS/MS: comparison with HPLC with electrochemical detection. J Pharm Biomed Anal. 2012 Dec;71:111-8. doi: 10.1016/j.jpba.2012.08.013. Epub 2012 Aug 23.
PubMed 22947504Turnu L, Di Minno A, Porro B, Squellerio I, Bonomi A, Manega CM, Werba JP, Parolari A, Tremoli E, Cavalca V. Assessing Free-Radical-Mediated DNA Damage during Cardiac Surgery: 8-Oxo-7,8-dihydro-2'-deoxyguanosine as a Putative Biomarker. Oxid Med Cell Longev. 2017;2017:9715898. doi: 10.1155/2017/9715898. Epub 2017 Jun 4.
PubMed 28660009Cavalca V, Minardi F, Scurati S, Guidugli F, Squellerio I, Veglia F, Dainese L, Guarino A, Tremoli E, Caruso D. Simultaneous quantification of 8-iso-prostaglandin-F(2alpha) and 11-dehydro thromboxane B(2) in human urine by liquid chromatography-tandem mass spectrometry. Anal Biochem. 2010 Feb 15;397(2):168-74. doi: 10.1016/j.ab.2009.10.014. Epub 2009 Oct 13.
PubMed 19825360Purcell S, Neale B, Todd-Brown K, Thomas L, Ferreira MA, Bender D, Maller J, Sklar P, de Bakker PI, Daly MJ, Sham PC. PLINK: a tool set for whole-genome association and population-based linkage analyses. Am J Hum Genet. 2007 Sep;81(3):559-75. doi: 10.1086/519795. Epub 2007 Jul 25.
PubMed 17701901Amadio P, Colombo GI, Tarantino E, Gianellini S, Ieraci A, Brioschi M, Banfi C, Werba JP, Parolari A, Lee FS, Tremoli E, Barbieri SS. BDNFVal66met polymorphism: a potential bridge between depression and thrombosis. Eur Heart J. 2017 May 7;38(18):1426-1435. doi: 10.1093/eurheartj/ehv655.
PubMed 26705390Casella M, Dello Russo A, Russo E, Catto V, Pizzamiglio F, Zucchetti M, Majocchi B, Riva S, Vettor G, Dessanai MA, Fassini G, Moltrasio M, Tundo F, Vignati C, Conti S, Bonomi A, Carbucicchio C, Di Biase L, Natale A, Tondo C. X-Ray Exposure in Cardiac Electrophysiology: A Retrospective Analysis in 8150 Patients Over 7 Years of Activity in a Modern, Large-Volume Laboratory. J Am Heart Assoc. 2018 May 22;7(11):e008233. doi: 10.1161/JAHA.117.008233.
PubMed 29789334Catto V, Stronati G, Porro B, Fiorelli S, Ricci V, Vavassori C, Russo E, Guerra F, Gasperetti A, Ribatti V, Sicuso R, Dello Russo A, Veglia F, Tondo C, Cavalca V, Colombo GI, Tremoli E, Casella M. Cardiac arrhythmia catheter ablation procedures guided by x-ray imaging: N-acetylcysteine protection against radiation-induced cellular damage (CARAPACE study): study design. J Interv Card Electrophysiol. 2021 Sep;61(3):577-582. doi: 10.1007/s10840-020-00853-4. Epub 2020 Aug 24.
PubMed 32833109
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Arrhythmia Catheter Ablation Procedures Guided by x-Ray Imaging: N-Acetylcysteine Protection Against Radiation Induced Cellular damagE (CARAPACE Study)
- ClinicalTrials.gov ID
- NCT04154982
- Acronym / sponsor ID
- CARAPACE / CCM1006
- Conditions
- Cardiac Arrhythmia
- Keywords
- Electrophysiology, Arrhythmias, Arrhythmia ablation, Ionizing radiation risk, Oxidative stress, DNA damage biomarkers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Centro Cardiologico MonzinoUniversity, hospital or other
- Collaborators
- Ministry of Health, Italy
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 2 Dec 2024 (actual)
- Study completion
- 2 Dec 2024 (actual)
- First posted
- 7 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Catheter ablation procedures (CAPs) are first line treatment for a great variety of cardiac arrhythmias. CAPs require X-Ray imaging; consequently, CAPs cause ionizing radiation (IR) exposure for patients. Exposure to IR, even at low-doses, increases individual risk of developing cancer. IR cause DNA damage directly and, mostly, indirectly by formation of cellular free radicals. Furthermore different response to IR results from inherited variants in genes involved in DNA damage repair. N-acetylcysteine (NAC) is an aminoacid that can directly neutralize free radicals and increase antioxidant systems. Our preliminary data suggest that IR exposure in patients undergoing CAP deranges the oxidative stress status and the pre-procedure intravenous administration of NAC could decrease such abnormality.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacological treatment | Experimental | Drug: Acetyl cysteinePatients are treated with NAC prior to carrying out CAP. |
| Standard procedure | No intervention | –Patients are not treated with NAC. No placebo treatment is performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetyl cysteine1200 mg of NAC are intravenously administrated 1 hour prior to carrying out CAP. | Drug | Pharmacological treatment |
Primary outcome
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).
3 secondary outcomes
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 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 the response to NAC administration related to inherited variants in genes involved in DNA damage repair.
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Background: PubMed 28938845Turnu L, Porro B, Alfieri V, Di Minno A, Russo E, Barbieri S, Bonomi A, Dello Russo A, Tondo C, D'Alessandra Y, Cavalca V, Tremoli E, Colombo GI, Casella M. Does Fluoroscopy Induce DNA Oxidative Damage in Patients Undergoing Catheter Ablation? Antioxid Redox Signal. 2018 Apr 20;28(12):1137-1143. doi: 10.1089/ars.2017.7334. Epub 2017 Nov 27.
- Background: PubMed 24792380Heidbuchel H, Wittkampf FH, Vano E, Ernst S, Schilling R, Picano E, Mont L, Jais P, de Bono J, Piorkowski C, Saad E, Femenia F. Practical ways to reduce radiation dose for patients and staff during device implantations and electrophysiological procedures. Europace. 2014 Jul;16(7):946-64. doi: 10.1093/europace/eut409. Epub 2014 May 2.
- Background: PubMed 15341901Evans MD, Dizdaroglu M, Cooke MS. Oxidative DNA damage and disease: induction, repair and significance. Mutat Res. 2004 Sep;567(1):1-61. doi: 10.1016/j.mrrev.2003.11.001.
- Background: PubMed 19393248Andreassi MG, Foffa I, Manfredi S, Botto N, Cioppa A, Picano E. Genetic polymorphisms in XRCC1, OGG1, APE1 and XRCC3 DNA repair genes, ionizing radiation exposure and chromosomal DNA damage in interventional cardiologists. Mutat Res. 2009 Jun 18;666(1-2):57-63. doi: 10.1016/j.mrfmmm.2009.04.003. Epub 2009 Apr 22.
- Background: PubMed 27878387Huang A, Glick SA. Genetic susceptibility to cutaneous radiation injury. Arch Dermatol Res. 2017 Jan;309(1):1-10. doi: 10.1007/s00403-016-1702-3. Epub 2016 Nov 22.
- Background: PubMed 28852434Cervelli T, Panetta D, Navarra T, Gadhiri S, Salvadori P, Galli A, Caramella D, Basta G, Picano E, Del Turco S. A New Natural Antioxidant Mixture Protects against Oxidative and DNA Damage in Endothelial Cell Exposed to Low-Dose Irradiation. Oxid Med Cell Longev. 2017;2017:9085947. doi: 10.1155/2017/9085947. Epub 2017 Aug 9.
- Background: PubMed 29742938Aldini G, Altomare A, Baron G, Vistoli G, Carini M, Borsani L, Sergio F. N-Acetylcysteine as an antioxidant and disulphide breaking agent: the reasons why. Free Radic Res. 2018 Jul;52(7):751-762. doi: 10.1080/10715762.2018.1468564. Epub 2018 May 9.
- Background: PubMed 29705904Mu H, Sun J, Li L, Yin J, Hu N, Zhao W, Ding D, Yi L. Ionizing radiation exposure: hazards, prevention, and biomarker screening. Environ Sci Pollut Res Int. 2018 Jun;25(16):15294-15306. doi: 10.1007/s11356-018-2097-9. Epub 2018 Apr 29.
- Background: PubMed 22947504Squellerio I, Caruso D, Porro B, Veglia F, Tremoli E, Cavalca V. Direct glutathione quantification in human blood by LC-MS/MS: comparison with HPLC with electrochemical detection. J Pharm Biomed Anal. 2012 Dec;71:111-8. doi: 10.1016/j.jpba.2012.08.013. Epub 2012 Aug 23.
- Background: PubMed 28660009Turnu L, Di Minno A, Porro B, Squellerio I, Bonomi A, Manega CM, Werba JP, Parolari A, Tremoli E, Cavalca V. Assessing Free-Radical-Mediated DNA Damage during Cardiac Surgery: 8-Oxo-7,8-dihydro-2'-deoxyguanosine as a Putative Biomarker. Oxid Med Cell Longev. 2017;2017:9715898. doi: 10.1155/2017/9715898. Epub 2017 Jun 4.
- Background: PubMed 19825360Cavalca V, Minardi F, Scurati S, Guidugli F, Squellerio I, Veglia F, Dainese L, Guarino A, Tremoli E, Caruso D. Simultaneous quantification of 8-iso-prostaglandin-F(2alpha) and 11-dehydro thromboxane B(2) in human urine by liquid chromatography-tandem mass spectrometry. Anal Biochem. 2010 Feb 15;397(2):168-74. doi: 10.1016/j.ab.2009.10.014. Epub 2009 Oct 13.
- Background: PubMed 17701901Purcell S, Neale B, Todd-Brown K, Thomas L, Ferreira MA, Bender D, Maller J, Sklar P, de Bakker PI, Daly MJ, Sham PC. PLINK: a tool set for whole-genome association and population-based linkage analyses. Am J Hum Genet. 2007 Sep;81(3):559-75. doi: 10.1086/519795. Epub 2007 Jul 25.
- Expert Consensus Document on Optimal Use of Ionizing Radiation in Cardiovascular ImagingLink provided by the sponsor.
- National Research Council. 2006. Health Risks from Exposure to Low Levels of Ionizing Radiation: BEIR VII Phase 2. Washington, DC: The National Academies Press.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acetyl cysteine in people with Cardiac Arrhythmia, run by Centro Cardiologico Monzino at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04154982, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.