Acute Myocardial InfarctionCopSCANCT05902117
Place of Copeptin-troponin Assay in the Elimination Diagnosis of Non-ST+ ACS
A study testing Troponin and Copeptin assay in people with Acute Myocardial Infarction, run by Hôpital NOVO at 2 sites in France.
Trial summary
The aim of this study is to demonstrate that a combined troponin and copeptin assay can exclude non-ST+ ACS in patients with chest pain less than 6 hours old. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Troponin and Copeptin assay
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 2 sitesFrance
- Study dates
- 28 Jun 2023to 28 Feb 2025
- Phase
- Interventional
- 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 ≥18 years old
- Presenting at the Pontoise emergency department by their own means / ambulance or patients taken care of by the SMUR and referred to the NOVO hospital - Pontoise site
- Chest pain less than 6 hours old
- Chest pain suggestive of ACS (compressive, intense pain, radiating into the arm and neck, mid-thoracic, left thoracic or epigastric location)
- Non-contributory ECG (no ST elevation, presence of bundle branch block)
- Informed and having expressed no objection
Show all 14Show fewer
- Beneficiary of a social security system (or entitled person)
- Non -Inclusion Criteria:
- Sus ST-segment shift on ECG (ACS ST+)
- Intermittent pain/unclear onset time
- Pregnant woman
- Pain in the context of trauma
- Patient under guardianship
- Patient does not speak or understand French
Who cannot join
- Non-ultrasensitive troponin measurement positive during the 1st SMUR sampling (> 0.08 ng.dL)
- Patient not referred to the NOVO hospital - Pontoise site by the SMUR
Trial locations and contacts
2 sites in 1 country.
France2 sites
Emergency Department (SAMU) Hospital NOVO - Pontoise site
Pontoise, 95300
Emergency Service - UHCD Hospital NOVO - Pontoise site
Pontoise, 95300
About this study
Official title: Place of Copeptin-troponin Assay in the Elimination Diagnosis of Non-ST+ ACS in the Management of Pre-hospital and In-hospital Non-traumatic Chest Pain in Adults
The aim of this study is to demonstrate that a combined troponin and copeptin assay can exclude non-ST+ ACS in patients with chest pain less than 6 hours old.
Read the detailed description
Chest pain accounts for about 10% of emergency service visits, which represents between 6 and 8 million visits per year in the United States and 15 million in Europe. Depending on the series, coronary etiology is found in 10 to 50% of cases.
Two types of coronary syndrome are distinguished according to the existence of a pathological change in the electrocardiogram.
ST+ acute coronary syndrome is a diagnosis based on the association of chest pain associated with an electrocardiogram change in the form of ST-segment elevation in a systemic territory corresponding to the complete obstruction of an artery of the coronary network.
Non-ST+ coronary syndrome is more difficult to diagnose, as the ECG is not pathological or cannot be interpreted due to the presence of conduction disorders. The diagnosis is currently based on the pathological increase of a specific myocardial biomarker in the blood: troponin.
If the pain is recent (less than six hours) the troponin measured on arrival may be falsely negative, and therefore requires a second measurement 3 hours after the first one (this is the troponin cycle). This second test therefore leads to a longer stay for patients requiring it and contributes to the saturation of the emergency service.
Copeptin is an endogenous stress biomarker that rises immediately during a myocardial infarction and decreases rapidly. Unlike troponin, this marker is not myocardial specific and its level can rise in the blood for many reasons, which is why this marker cannot be used alone in the diagnosis of non-ST+ acute coronary syndrome (non-ST+ ACS or ST- ACS).
The hypothesis would be that the association of a copeptin assay with the initial troponin assay could, if both markers are below pathological thresholds (Troponin < 16ng.dL), eliminate the diagnosis of acute coronary syndrome from the first assays and thus avoid the second troponin assay 3 hours after the first. The patient would reduce the time spent in the emergency and would thus reduce the number of patients in the emergency service.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Troponin and Copeptin assay
- Keywords
- Acute Myocardial Infarction, Troponine, Copeptine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Troponin and Copeptin assayDiagnostic test
Collection of an additional blood tube for copeptin determination during blood collection for troponin testing as part of care.
| Study group | Role | What they receive |
|---|---|---|
| Troponin and Copeptin assay | Experimental | Collection of an additional blood tube for copeptin determination during blood collection for troponin testing as part of care. Receives: Diagnostic Test: Troponin and Copeptin assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate that a combined troponin and copeptin assay can exclude non-ST+ ACS in patients with chest pain less than 6 hours old (sensitivity/specificity)
Comparison of copeptin and troponin assays in the final diagnosis of non-ST+ ACS based on emergency medical records by calculation the sensitivity/specificity of the troponin - copeptin pair.
Measured: At the end of the study, an average of 8 month
Demonstrate that a combined troponin and copeptin assay can exclude non-ST+ ACS in patients with chest pain less than 6 hours old (negative predictive value)
Comparison of copeptin and troponin assays in the final diagnosis of non-ST+ ACS based on emergency medical records by calculation of the negative predictive value of the troponin - copeptin pair.
Measured: At the end of the study, an average of 8 month
Secondary outcomes (5)
Evaluation of the diagnostic performance (sensitivity/specificity) of the troponin/ copeptin association according to cardiovascular risk factors (age, smoking, hypertension, history of cardiac ischemia, overweight, heredity)
Evaluation of the diagnostic performance (sensitivity/specificity) of the troponin - copeptin pair for each subgroup of cardiovascular risk factors (age / smoking / hypertension / history of cardiac ischemia / overweight and heredity).
Measured: At the end of the study, an average of 8 month
Evaluation of the diagnostic performance (negative predictive value) of the troponin/ copeptin association according to cardiovascular risk factors (age, smoking, hypertension, history of cardiac ischemia, overweight, heredity)
Evaluation of the diagnostic performance (negative predictive value) of the troponin - copeptin pair for each subgroup of cardiovascular risk factors (age / smoking / hypertension / history of cardiac ischemia / overweight and heredity).
Measured: At the end of the study, an average of 8 month
Evaluation of the patient's length of stay
Collection of the number of days or hours spent in the emergency service from the time of arrival
Measured: At the end of the Study, an average of 8 month
Evaluation of the diagnostic performance of the troponin/ copeptin combination according to the time from onset of pain
The diagnostic performance of the troponin/ copeptin combination is evaluated according to the time between the first pain and blood sampling
Measured: At the end of the study, an average of 8 month
Evaluation of pain management in emergency service
Assessment of the evolution of pain via the numerical scale (EN), rated from 0 to 10, between arrival in the emergency room and reassessment at 3 hours
Measured: At the end of the study, an average of 8 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start28 Jun 2023
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Olivier Fancelli, Principal investigator, NOVO Hospital - Pontoise Site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05902117
- Sponsor's protocol ID
- CHRD0821
- Acronym
- CopSCA
- Status last verified
- Jun 2024
- First submitted
- 11 May 2023
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mockel M, Searle J, Muller R, Slagman A, Storchmann H, Oestereich P, Wyrwich W, Ale-Abaei A, Vollert JO, Koch M, Somasundaram R. Chief complaints in medical emergencies: do they relate to underlying disease and outcome? The Charite Emergency Medicine Study (CHARITEM). Eur J Emerg Med. 2013 Apr;20(2):103-8. doi: 10.1097/MEJ.0b013e328351e609.
PubMed 22387754Fanaroff AC, Rymer JA, Goldstein SA, Simel DL, Newby LK. Does This Patient With Chest Pain Have Acute Coronary Syndrome?: The Rational Clinical Examination Systematic Review. JAMA. 2015 Nov 10;314(18):1955-65. doi: 10.1001/jama.2015.12735.
PubMed 26547467Dawson C, Benger JR, Bayly G. Serial high-sensitivity troponin measurements for the rapid exclusion of acute myocardial infarction in low-risk patients. Emerg Med J. 2013 Jul;30(7):593-4. doi: 10.1136/emermed-2012-201574. Epub 2012 Jul 31.
PubMed 22851671Khan SQ, Dhillon OS, O'Brien RJ, Struck J, Quinn PA, Morgenthaler NG, Squire IB, Davies JE, Bergmann A, Ng LL. C-terminal provasopressin (copeptin) as a novel and prognostic marker in acute myocardial infarction: Leicester Acute Myocardial Infarction Peptide (LAMP) study. Circulation. 2007 Apr 24;115(16):2103-10. doi: 10.1161/CIRCULATIONAHA.106.685503. Epub 2007 Apr 9.
PubMed 17420344Kim KS, Suh GJ, Song SH, Jung YS, Kim T, Shin SM, Kang MW, Lee MS. Copeptin with high-sensitivity troponin at presentation is not inferior to serial troponin measurements for ruling out acute myocardial infarction. Clin Exp Emerg Med. 2020 Mar;7(1):35-42. doi: 10.15441/ceem.19.013. Epub 2020 Mar 31.
PubMed 32252132Szarpak L, Lapinski M, Gasecka A, Pruc M, Drela WL, Koda M, Denegri A, Peacock FW, Jaguszewski MJ, Filipiak KJ. Performance of Copeptin for Early Diagnosis of Acute Coronary Syndromes: A Systematic Review and Meta-Analysis of 14,139 Patients. J Cardiovasc Dev Dis. 2021 Dec 27;9(1):6. doi: 10.3390/jcdd9010006.
PubMed 35050216Aarts GWA, van der Wulp K, Camaro C. Pre-hospital point-of-care troponin measurement: a clinical example of its additional value. Neth Heart J. 2020 Oct;28(10):514-519. doi: 10.1007/s12471-020-01434-w.
PubMed 32514934Kohn MA, Kwan E, Gupta M, Tabas JA. Prevalence of acute myocardial infarction and other serious diagnoses in patients presenting to an urban emergency department with chest pain. J Emerg Med. 2005 Nov;29(4):383-90. doi: 10.1016/j.jemermed.2005.04.010.
PubMed 16243193Charpentier S, Beaune S, Joly LM, Khoury A, Duchateau FX, Briot R, Renaud B, Ageron FX; IRU Network. Management of chest pain in the French emergency healthcare system: the prospective observational EPIDOULTHO study. Eur J Emerg Med. 2018 Dec;25(6):404-410. doi: 10.1097/MEJ.0000000000000481.
PubMed 28723703Hamm CW, Bassand JP, Agewall S, Bax J, Boersma E, Bueno H, Caso P, Dudek D, Gielen S, Huber K, Ohman M, Petrie MC, Sonntag F, Uva MS, Storey RF, Wijns W, Zahger D; ESC Committee for Practice Guidelines. ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: The Task Force for the management of acute coronary syndromes (ACS) in patients presenting without persistent ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2011 Dec;32(23):2999-3054. doi: 10.1093/eurheartj/ehr236. Epub 2011 Aug 26. No abstract available.
PubMed 21873419
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Place of Copeptin-troponin Assay in the Elimination Diagnosis of Non-ST+ ACS in the Management of Pre-hospital and In-hospital Non-traumatic Chest Pain in Adults
- ClinicalTrials.gov ID
- NCT05902117
- Acronym / sponsor ID
- CopSCA / CHRD0821
- Conditions
- Acute Myocardial Infarction
- Keywords
- Acute Myocardial Infarction, Troponine, Copeptine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- 28 Jun 2023 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 13 Jun 2023 (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.
The aim of this study is to demonstrate that a combined troponin and copeptin assay can exclude non-ST+ ACS in patients with chest pain less than 6 hours old.
Detailed description
Chest pain accounts for about 10% of emergency service visits, which represents between 6 and 8 million visits per year in the United States and 15 million in Europe. Depending on the series, coronary etiology is found in 10 to 50% of cases.
Two types of coronary syndrome are distinguished according to the existence of a pathological change in the electrocardiogram.
ST+ acute coronary syndrome is a diagnosis based on the association of chest pain associated with an electrocardiogram change in the form of ST-segment elevation in a systemic territory corresponding to the complete obstruction of an artery of the coronary network.
Non-ST+ coronary syndrome is more difficult to diagnose, as the ECG is not pathological or cannot be interpreted due to the presence of conduction disorders. The diagnosis is currently based on the pathological increase of a specific myocardial biomarker in the blood: troponin.
If the pain is recent (less than six hours) the troponin measured on arrival may be falsely negative, and therefore requires a second measurement 3 hours after the first one (this is the troponin cycle). This second test therefore leads to a longer stay for patients requiring it and contributes to the saturation of the emergency service.
Copeptin is an endogenous stress biomarker that rises immediately during a myocardial infarction and decreases rapidly. Unlike troponin, this marker is not myocardial specific and its level can rise in the blood for many reasons, which is why this marker cannot be used alone in the diagnosis of non-ST+ acute coronary syndrome (non-ST+ ACS or ST- ACS).
The hypothesis would be that the association of a copeptin assay with the initial troponin assay could, if both markers are below pathological thresholds (Troponin < 16ng.dL), eliminate the diagnosis of acute coronary syndrome from the first assays and thus avoid the second troponin assay 3 hours after the first. The patient would reduce the time spent in the emergency and would thus reduce the number of patients in the emergency service.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Troponin and Copeptin assay | Experimental | Diagnostic Test: Troponin and Copeptin assayCollection of an additional blood tube for copeptin determination during blood collection for troponin testing as part of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patient ≥18 years old
- Presenting at the Pontoise emergency department by their own means / ambulance or patients taken care of by the SMUR and referred to the NOVO hospital - Pontoise site
- Chest pain less than 6 hours old
- Chest pain suggestive of ACS (compressive, intense pain, radiating into the arm and neck, mid-thoracic, left thoracic or epigastric location)
- Non-contributory ECG (no ST elevation, presence of bundle branch block)
Key exclusion criteria (2 listed)
- Non-ultrasensitive troponin measurement positive during the 1st SMUR sampling (> 0.08 ng.dL)
- Patient not referred to the NOVO hospital - Pontoise site by the SMUR
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 |
|---|---|---|
| Troponin and Copeptin assayCollection of an additional blood tube for copeptin determination during blood collection for troponin testing as part of care. | Diagnostic test | Troponin and Copeptin assay |
Primary outcome
Demonstrate that a combined troponin and copeptin assay can exclude non-ST+ ACS in patients with chest pain less than 6 hours old (sensitivity/specificity)
Time frame: At the end of the study, an average of 8 month
Comparison of copeptin and troponin assays in the final diagnosis of non-ST+ ACS based on emergency medical records by calculation the sensitivity/specificity of the troponin - copeptin pair.
Demonstrate that a combined troponin and copeptin assay can exclude non-ST+ ACS in patients with chest pain less than 6 hours old (negative predictive value)
Time frame: At the end of the study, an average of 8 month
Comparison of copeptin and troponin assays in the final diagnosis of non-ST+ ACS based on emergency medical records by calculation of the negative predictive value of the troponin - copeptin pair.
5 secondary outcomes
Evaluation of the diagnostic performance (sensitivity/specificity) of the troponin/ copeptin association according to cardiovascular risk factors (age, smoking, hypertension, history of cardiac ischemia, overweight, heredity)
Time frame: At the end of the study, an average of 8 month
Evaluation of the diagnostic performance (negative predictive value) of the troponin/ copeptin association according to cardiovascular risk factors (age, smoking, hypertension, history of cardiac ischemia, overweight, heredity)
Time frame: At the end of the study, an average of 8 month
Evaluation of the patient's length of stay
Time frame: At the end of the Study, an average of 8 month
Evaluation of the diagnostic performance of the troponin/ copeptin combination according to the time from onset of pain
Time frame: At the end of the study, an average of 8 month
Evaluation of pain management in emergency service
Time frame: At the end of the study, an average of 8 month
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 18 Mar 2025.
- Background: PubMed 22387754Mockel M, Searle J, Muller R, Slagman A, Storchmann H, Oestereich P, Wyrwich W, Ale-Abaei A, Vollert JO, Koch M, Somasundaram R. Chief complaints in medical emergencies: do they relate to underlying disease and outcome? The Charite Emergency Medicine Study (CHARITEM). Eur J Emerg Med. 2013 Apr;20(2):103-8. doi: 10.1097/MEJ.0b013e328351e609.
- Background: PubMed 26547467Fanaroff AC, Rymer JA, Goldstein SA, Simel DL, Newby LK. Does This Patient With Chest Pain Have Acute Coronary Syndrome?: The Rational Clinical Examination Systematic Review. JAMA. 2015 Nov 10;314(18):1955-65. doi: 10.1001/jama.2015.12735.
- Background: PubMed 22851671Dawson C, Benger JR, Bayly G. Serial high-sensitivity troponin measurements for the rapid exclusion of acute myocardial infarction in low-risk patients. Emerg Med J. 2013 Jul;30(7):593-4. doi: 10.1136/emermed-2012-201574. Epub 2012 Jul 31.
- Background: PubMed 17420344Khan SQ, Dhillon OS, O'Brien RJ, Struck J, Quinn PA, Morgenthaler NG, Squire IB, Davies JE, Bergmann A, Ng LL. C-terminal provasopressin (copeptin) as a novel and prognostic marker in acute myocardial infarction: Leicester Acute Myocardial Infarction Peptide (LAMP) study. Circulation. 2007 Apr 24;115(16):2103-10. doi: 10.1161/CIRCULATIONAHA.106.685503. Epub 2007 Apr 9.
- Background: PubMed 32252132Kim KS, Suh GJ, Song SH, Jung YS, Kim T, Shin SM, Kang MW, Lee MS. Copeptin with high-sensitivity troponin at presentation is not inferior to serial troponin measurements for ruling out acute myocardial infarction. Clin Exp Emerg Med. 2020 Mar;7(1):35-42. doi: 10.15441/ceem.19.013. Epub 2020 Mar 31.
- Background: PubMed 35050216Szarpak L, Lapinski M, Gasecka A, Pruc M, Drela WL, Koda M, Denegri A, Peacock FW, Jaguszewski MJ, Filipiak KJ. Performance of Copeptin for Early Diagnosis of Acute Coronary Syndromes: A Systematic Review and Meta-Analysis of 14,139 Patients. J Cardiovasc Dev Dis. 2021 Dec 27;9(1):6. doi: 10.3390/jcdd9010006.
- Background: PubMed 32514934Aarts GWA, van der Wulp K, Camaro C. Pre-hospital point-of-care troponin measurement: a clinical example of its additional value. Neth Heart J. 2020 Oct;28(10):514-519. doi: 10.1007/s12471-020-01434-w.
- Background: PubMed 16243193Kohn MA, Kwan E, Gupta M, Tabas JA. Prevalence of acute myocardial infarction and other serious diagnoses in patients presenting to an urban emergency department with chest pain. J Emerg Med. 2005 Nov;29(4):383-90. doi: 10.1016/j.jemermed.2005.04.010.
- Background: PubMed 28723703Charpentier S, Beaune S, Joly LM, Khoury A, Duchateau FX, Briot R, Renaud B, Ageron FX; IRU Network. Management of chest pain in the French emergency healthcare system: the prospective observational EPIDOULTHO study. Eur J Emerg Med. 2018 Dec;25(6):404-410. doi: 10.1097/MEJ.0000000000000481.
- Background: PubMed 21873419Hamm CW, Bassand JP, Agewall S, Bax J, Boersma E, Bueno H, Caso P, Dudek D, Gielen S, Huber K, Ohman M, Petrie MC, Sonntag F, Uva MS, Storey RF, Wijns W, Zahger D; ESC Committee for Practice Guidelines. ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: The Task Force for the management of acute coronary syndromes (ACS) in patients presenting without persistent ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2011 Dec;32(23):2999-3054. doi: 10.1093/eurheartj/ehr236. Epub 2011 Aug 26. No abstract available.
- Does This Patient With Chest Pain Have Acute Coronary Syndrome?Link provided by the sponsor.
- Risk stratification of acute coronary syndromes (ST+ and non-ST+)Link provided by the sponsor.
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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.
Dr Olivier Fancelli principal investigator
NOVO Hospital - Pontoise Site
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Troponin and Copeptin assay in people with Acute Myocardial Infarction, run by Hôpital NOVO at 2 sites in France.
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 14 inclusion and 2 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 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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.
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?
Demonstrate that a combined troponin and copeptin assay can exclude non-ST+ ACS in patients with chest pain less than 6 hours old (sensitivity/specificity) (time frame: At the end of the study, an average of 8 month). The study lists 2 primary outcomes in all. 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 NCT05902117, which also lists 10 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 18 Mar 2025.