Chest PainCLEOS-CPDSNCT03439449
Computerized Medical History Taking for Acute Chest Pain
An observational study of Chest Pain and Acute Coronary Syndrome, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The aim is to determine the additional value of computerized, patient-entered medical histories for the management of patients presenting at the emergency department with chest pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chest Pain, Acute Coronary Syndrome
- What is being tested?
- CLEOS software program and Physician taken history
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 2,000 participants
- Where
- 1 siteSweden
- Study dates
- 1 May 2017to 31 Dec 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Consecutive patients presenting at the emergency department with chest pain as presenting complaint.
Who may be able to join
- Chest pain recorded by a triage nurse or registrar
- Fluency in Swedish or English
- Non-diagnostic first ECG and/or serum markers
- Manchester triage 2-5
- Informed consent
Who cannot join
- Inability to carry out computerized history-taking on the dedicated device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Computerized, Patient-entered Medical Histories for Managing Chest Pain in the Emergency Department
The aim is to determine the additional value of computerized, patient-entered medical histories for the management of patients presenting at the emergency department with chest pain.
Read the detailed description
The purpose of this study is to determine the value of a detailed medical history, acquired by computer-directed, patient self-entry of data, for efficient disposition of patients presenting to the emergency department (ED) with chest pain and non-diagnostic first ECG and/or serum markers for acute coronary syndrome (ACS). The research questions posed are: will the added data and systems-based analysis of the data provided by computerization of these processes, as compared with routine physician-acquired histories and analysis; (1) safely risk stratify patients with chest pain, and (2) save time and resources?
Computerized, patient-entered histories will be collected with the software program CLEOS running on tablets (iPad®, Apple Inc, Cupertino, California, USA). The histories to be collected include demographic data, present illness, systems review, past medical history, prescription drugs, previous adverse drug reactions, social history, life-style risks, and family history. Histories will be collected during wait times in the ED, e.g., before patients are seen by a physician and while patients wait for reports of laboratory data collected by routine care.
Data acquired by CLEOS will be related to clinical outcomes in the acute setting and at 30 days and 1 year post-presentation for patients without documented ACS in the acute setting. Outcomes for all patients will be extracted from hospital records and national registries.
For the validation and future development of CLEOS, interviews with patients for the evaluation of patient experience regarding feasibility, acceptance, comprehensiveness and technical aspects of answering the CLEOS interview will take place within one to three months after the ED visit.
This is an exploratory study in which the calculation of the number of participating patients is based on the desired precision of sensitivity and specificity. Assuming that the prevalence is 0.5 (50 %), a power calculation with nQuery® version 7.0 (Statistical Solutions Ltd, Boston, Massachusetts, USA) shows that with 1000 patients the estimated precision of sensitivity and specificity is ±0.03 (3 %). The more the extreme the result, i.e. sensitivity or specificity approaching 0 or 1 (100 %), the higher the precision. The models will be developed in the first 50% of the data acquired (training data set) and validated in the last 50% of the data acquired (validation data set). We also intend to make estimates in subgroups. To ascertain that such estimates can be done, an even larger number of patients must be recruited. Thus, the study intends to recruit data from approximately 2000 patients.
Taken together, this study:
- will evaluate established clinical guidelines risk scores, as populated with CLEOS data, and compare these results with data obtained during the concurrent ED visit and made available in the standard hospital medical records;
- will assess how data collected with CLEOS in combination with established risk scores can rule-in and rule-out a diagnosis of an ACS, we will calculate sensitivity, specificity and negative and positive predictive value;
- aim to develop new risk prediction scores for patients with chest pain, based on data collected with CLEOS; and
- will evaluate economic aspects of routine care, as compared with management by CLEOS by using standard health economy procedures and analyses to determine the resource utilization and cost differences between management according to guidelines, based on data collected with CLEOS, and current clinical practice.
- Conditions
- Chest Pain, Acute Coronary Syndrome
- Being tested
- CLEOS software program, Physician taken history
- Keywords
- History taking, Risk stratification
- Medical subject headings
- Chest Pain, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLEOS software programDevice
Computer-assisted history taking program
Physician taken historyProcedure or surgery
Conventional history taking by physicians
What is being measured
The primary outcome is the main question the study is designed to answer.
A correct diagnosis of an acute coronary syndrome by use of computer-assisted patient entered history or standard history obtained by the cardiologist in attendance
The primary objective is to determine whether the use of computer-assisted patient entered history is better than a standard history obtained by the cardiologist in attendance for the prediction and safe exclusion of an acute coronary syndrome (ACS) in the acute setting in patients with non-diagnostic ECG and/or serum markers. Thus, the primary endpoint is the comparison between the two methods for the proportion of patients with a correct diagnosis of ACS or not ACS in the acute setting, The diagnosis of ACS or not ACS is defined as a validated clinical endpoint within 7 days
Measured: 7 days
Secondary outcomes (5)
A correct exclusion of an acute coronary syndrome up to 30 days by use of computer-assisted patient entered history or standard history obtained by the cardiologist in attendance
To determine whether the use of computer-assisted patient entered history is better than a standard history obtained by the cardiologist in attendance to exclude an acute coronary syndrome (ACS) in the acute setting in patients with non-diagnostic ECG and/or serum markers. Thus, this secondary endpoint is the comparison between the two methods for the proportion of patients with a correct exclusion of ACS in the acute setting, The diagnosis of ACS is defined as a validated clinical endpoint within 30 days
Measured: 30 days
A correct exclusion of an acute coronary syndrome up to 1 year by use of computer-assisted patient entered history or standard history obtained by the cardiologist in attendance
To determine whether the use of computer-assisted patient entered history is better than a standard history obtained by the cardiologist in attendance to exclude an acute coronary syndrome (ACS) in the acute setting in patients with non-diagnostic ECG and/or serum markers. Thus, this secondary endpoint is the comparison between the two methods for the proportion of patients with a correct exclusion of ACS in the acute setting, The diagnosis of ACS is defined as a validated clinical endpoint within 1 year
Measured: 1 year
Direct costs for a patient with a diagnosis of an acute coronary syndrome when patient selection is based on computer-assisted patient entered history, as compared to standard history obtained by the cardiologist in attendance
To measure direct costs for a patient with a diagnosis of an acute coronary syndrome when patient selection is based on computer-assisted patient entered history, as compared to standard history obtained by the cardiologist in attendance. Costs will be obtained patient-by-patient from medical records
Measured: 1 year
Patient experience with computer-assisted patient entered history measured as he proportion of patients who complete a computer-assisted patient entered history
To evaluate the proportion of patients who complete a full computer-assisted patient entered history.
Measured: 7 days
The ability of computer-assisted patient entered history, as compared to standard history obtained by the cardiologist in attendance to provide information required to calculate a TIMI risk score for an ACS.
To compare the proportions of patients with computer-assisted patient entered history, as compared to standard history obtained by the cardiologist in attendance, where there is sufficient information documented to calculate the Thrombolysis In Myocardial Infarction (TIMI) score. The TIMI score contains the following information: Age, risk factors for coronary artery disease (family history, hypertension, hypercholesterolemia, diabetes, current smoker), a significant coronary artery stenosis, ST segment deviation on the ECG, 2 or more anginal attacks within 24 h, use of aspirin within 7 days, and elevated serum cardiac biomarkers.
Measured: 7 and 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start1 May 2017
- Primary completion31 Dec 2024
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Chest PainStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Kahan, Karolinska Institutet
- Investigators
- Thomas Kahan, MD, PhD, Study chair, Karolinska InstitutetHelge Brandberg, MD, Study director, Karolinska InstitutetSabine Koch, PhD, Study director, Karolinska InstitutetJonas Spaak, MD, PhD, Study director, Karolinska InstitutetCarl Johan Sundberg, MD, PhD, Study director, Karolinska InstitutetDavid Zakim, MD, PhD, Study director, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03439449
- Sponsor's protocol ID
- KI-CLEOS-CPDS
- Acronym
- CLEOS-CPDS
- Status last verified
- Mar 2025
- First submitted
- 7 Feb 2018
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brandberg H, Sundberg CJ, Spaak J, Koch S, Kahan T. Are medical history data fit for risk stratification of patients with chest pain in emergency care? Comparing data collected from patients using computerized history taking with data documented by physicians in the electronic health record in the CLEOS-CPDS prospective cohort study. J Am Med Inform Assoc. 2024 Jun 20;31(7):1529-1539. doi: 10.1093/jamia/ocae110.
PubMed 38781350Sundberg K, Adeli A, Brandberg H, Spaak J, Koch S, Sundberg CJ, Zakim D, Kahan T, Fritzell K. User experience of self-reported computerized medical history taking for acute chest pain: The Clinical Expert Operating System Chest Pain Danderyd Study. Health Expect. 2022 Dec;25(6):3053-3061. doi: 10.1111/hex.13612. Epub 2022 Sep 23.
PubMed 36148691Brandberg H, Sundberg CJ, Spaak J, Koch S, Kahan T. Computerized Self-Reported Medical History Taking to Support Early Rule Out of Major Adverse Cardiac Events in Patients With Acute Chest Pain: Post Hoc Analysis of the CLEOS-CPDS Prospective Cohort Study. J Med Internet Res. 2026 Feb 11;28:e76087. doi: 10.2196/76087.
PubMed 41671573Fritzell K, Brandberg H, Spaak J, Koch S, Sundberg CJ, Zakim D, Kahan T, Sundberg K. Patient Perspectives on Digital Technology and Experiences of Computerized History-Taking for Chest Pain Management in the Emergency Department: CLEOS-CPDS Prospective Cohort Study. JMIR Med Inform. 2025 Jun 17;13:e65568. doi: 10.2196/65568.
PubMed 40526888Brandberg H, Schierenbeck F, Sundberg CJ, Koch S, Spaak J, Kahan T. Performance of computerized self-reported medical history taking and HEAR score for safe early rule-out of cardiac events in acute chest pain patients: the CLEOS-CPDS prospective cohort study. Eur Heart J Digit Health. 2024 Nov 12;6(1):104-114. doi: 10.1093/ehjdh/ztae087. eCollection 2025 Jan.
PubMed 39846077Zakim D, Brandberg H, El Amrani S, Hultgren A, Stathakarou N, Nifakos S, Kahan T, Spaak J, Koch S, Sundberg CJ. Computerized history-taking improves data quality for clinical decision-making-Comparison of EHR and computer-acquired history data in patients with chest pain. PLoS One. 2021 Sep 27;16(9):e0257677. doi: 10.1371/journal.pone.0257677. eCollection 2021.
PubMed 34570811Brandberg H, Sundberg CJ, Spaak J, Koch S, Zakim D, Kahan T. Use of Self-Reported Computerized Medical History Taking for Acute Chest Pain in the Emergency Department - the Clinical Expert Operating System Chest Pain Danderyd Study (CLEOS-CPDS): Prospective Cohort Study. J Med Internet Res. 2021 Apr 27;23(4):e25493. doi: 10.2196/25493.
PubMed 33904821Brandberg H, Kahan T, Spaak J, Sundberg K, Koch S, Adeli A, Sundberg CJ, Zakim D. A prospective cohort study of self-reported computerised medical history taking for acute chest pain: protocol of the CLEOS-Chest Pain Danderyd Study (CLEOS-CPDS). BMJ Open. 2020 Jan 21;10(1):e031871. doi: 10.1136/bmjopen-2019-031871.
PubMed 31969363
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized, Patient-entered Medical Histories for Managing Chest Pain in the Emergency Department
- ClinicalTrials.gov ID
- NCT03439449
- Acronym / sponsor ID
- CLEOS-CPDS / KI-CLEOS-CPDS
- Conditions
- Chest Pain, Acute Coronary Syndrome
- Keywords
- History taking, Risk stratification
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 20 Feb 2018 (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 is to determine the additional value of computerized, patient-entered medical histories for the management of patients presenting at the emergency department with chest pain.
Detailed description
The purpose of this study is to determine the value of a detailed medical history, acquired by computer-directed, patient self-entry of data, for efficient disposition of patients presenting to the emergency department (ED) with chest pain and non-diagnostic first ECG and/or serum markers for acute coronary syndrome (ACS). The research questions posed are: will the added data and systems-based analysis of the data provided by computerization of these processes, as compared with routine physician-acquired histories and analysis; (1) safely risk stratify patients with chest pain, and (2) save time and resources?
Computerized, patient-entered histories will be collected with the software program CLEOS running on tablets (iPad®, Apple Inc, Cupertino, California, USA). The histories to be collected include demographic data, present illness, systems review, past medical history, prescription drugs, previous adverse drug reactions, social history, life-style risks, and family history. Histories will be collected during wait times in the ED, e.g., before patients are seen by a physician and while patients wait for reports of laboratory data collected by routine care.
Data acquired by CLEOS will be related to clinical outcomes in the acute setting and at 30 days and 1 year post-presentation for patients without documented ACS in the acute setting. Outcomes for all patients will be extracted from hospital records and national registries.
For the validation and future development of CLEOS, interviews with patients for the evaluation of patient experience regarding feasibility, acceptance, comprehensiveness and technical aspects of answering the CLEOS interview will take place within one to three months after the ED visit.
This is an exploratory study in which the calculation of the number of participating patients is based on the desired precision of sensitivity and specificity. Assuming that the prevalence is 0.5 (50 %), a power calculation with nQuery® version 7.0 (Statistical Solutions Ltd, Boston, Massachusetts, USA) shows that with 1000 patients the estimated precision of sensitivity and specificity is ±0.03 (3 %). The more the extreme the result, i.e. sensitivity or specificity approaching 0 or 1 (100 %), the higher the precision. The models will be developed in the first 50% of the data acquired (training data set) and validated in the last 50% of the data acquired (validation data set). We also intend to make estimates in subgroups. To ascertain that such estimates can be done, an even larger number of patients must be recruited. Thus, the study intends to recruit data from approximately 2000 patients.
Taken together, this study:
- will evaluate established clinical guidelines risk scores, as populated with CLEOS data, and compare these results with data obtained during the concurrent ED visit and made available in the standard hospital medical records;
- will assess how data collected with CLEOS in combination with established risk scores can rule-in and rule-out a diagnosis of an ACS, we will calculate sensitivity, specificity and negative and positive predictive value;
- aim to develop new risk prediction scores for patients with chest pain, based on data collected with CLEOS; and
- will evaluate economic aspects of routine care, as compared with management by CLEOS by using standard health economy procedures and analyses to determine the resource utilization and cost differences between management according to guidelines, based on data collected with CLEOS, and current clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients presenting at the emergency department with chest pain as presenting complaint.
Key inclusion criteria (5 listed)
- Chest pain recorded by a triage nurse or registrar
- Fluency in Swedish or English
- Non-diagnostic first ECG and/or serum markers
- Manchester triage 2-5
- Informed consent
Key exclusion criteria (1 listed)
- Inability to carry out computerized history-taking on the dedicated device
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 |
|---|---|---|
| CLEOS software programComputer-assisted history taking program | Device | – |
| Physician taken historyConventional history taking by physicians | Procedure or surgery | – |
Primary outcome
A correct diagnosis of an acute coronary syndrome by use of computer-assisted patient entered history or standard history obtained by the cardiologist in attendance
Time frame: 7 days
The primary objective is to determine whether the use of computer-assisted patient entered history is better than a standard history obtained by the cardiologist in attendance for the prediction and safe exclusion of an acute coronary syndrome (ACS) in the acute setting in patients with non-diagnostic ECG and/or serum markers. Thus, the primary endpoint is the comparison between the two methods for the proportion of patients with a correct diagnosis of ACS or not ACS in the acute setting, The diagnosis of ACS or not ACS is defined as a validated clinical endpoint within 7 days
5 secondary outcomes
A correct exclusion of an acute coronary syndrome up to 30 days by use of computer-assisted patient entered history or standard history obtained by the cardiologist in attendance
Time frame: 30 days
A correct exclusion of an acute coronary syndrome up to 1 year by use of computer-assisted patient entered history or standard history obtained by the cardiologist in attendance
Time frame: 1 year
Direct costs for a patient with a diagnosis of an acute coronary syndrome when patient selection is based on computer-assisted patient entered history, as compared to standard history obtained by the cardiologist in attendance
Time frame: 1 year
Patient experience with computer-assisted patient entered history measured as he proportion of patients who complete a computer-assisted patient entered history
Time frame: 7 days
The ability of computer-assisted patient entered history, as compared to standard history obtained by the cardiologist in attendance to provide information required to calculate a TIMI risk score for an ACS.
Time frame: 7 and 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Results publication: PubMed 38781350Brandberg H, Sundberg CJ, Spaak J, Koch S, Kahan T. Are medical history data fit for risk stratification of patients with chest pain in emergency care? Comparing data collected from patients using computerized history taking with data documented by physicians in the electronic health record in the CLEOS-CPDS prospective cohort study. J Am Med Inform Assoc. 2024 Jun 20;31(7):1529-1539. doi: 10.1093/jamia/ocae110.
- Results publication: PubMed 36148691Sundberg K, Adeli A, Brandberg H, Spaak J, Koch S, Sundberg CJ, Zakim D, Kahan T, Fritzell K. User experience of self-reported computerized medical history taking for acute chest pain: The Clinical Expert Operating System Chest Pain Danderyd Study. Health Expect. 2022 Dec;25(6):3053-3061. doi: 10.1111/hex.13612. Epub 2022 Sep 23.
- Derived from this study: PubMed 41671573Brandberg H, Sundberg CJ, Spaak J, Koch S, Kahan T. Computerized Self-Reported Medical History Taking to Support Early Rule Out of Major Adverse Cardiac Events in Patients With Acute Chest Pain: Post Hoc Analysis of the CLEOS-CPDS Prospective Cohort Study. J Med Internet Res. 2026 Feb 11;28:e76087. doi: 10.2196/76087.
- Derived from this study: PubMed 40526888Fritzell K, Brandberg H, Spaak J, Koch S, Sundberg CJ, Zakim D, Kahan T, Sundberg K. Patient Perspectives on Digital Technology and Experiences of Computerized History-Taking for Chest Pain Management in the Emergency Department: CLEOS-CPDS Prospective Cohort Study. JMIR Med Inform. 2025 Jun 17;13:e65568. doi: 10.2196/65568.
- Derived from this study: PubMed 39846077Brandberg H, Schierenbeck F, Sundberg CJ, Koch S, Spaak J, Kahan T. Performance of computerized self-reported medical history taking and HEAR score for safe early rule-out of cardiac events in acute chest pain patients: the CLEOS-CPDS prospective cohort study. Eur Heart J Digit Health. 2024 Nov 12;6(1):104-114. doi: 10.1093/ehjdh/ztae087. eCollection 2025 Jan.
- Derived from this study: PubMed 34570811Zakim D, Brandberg H, El Amrani S, Hultgren A, Stathakarou N, Nifakos S, Kahan T, Spaak J, Koch S, Sundberg CJ. Computerized history-taking improves data quality for clinical decision-making-Comparison of EHR and computer-acquired history data in patients with chest pain. PLoS One. 2021 Sep 27;16(9):e0257677. doi: 10.1371/journal.pone.0257677. eCollection 2021.
- Derived from this study: PubMed 33904821Brandberg H, Sundberg CJ, Spaak J, Koch S, Zakim D, Kahan T. Use of Self-Reported Computerized Medical History Taking for Acute Chest Pain in the Emergency Department - the Clinical Expert Operating System Chest Pain Danderyd Study (CLEOS-CPDS): Prospective Cohort Study. J Med Internet Res. 2021 Apr 27;23(4):e25493. doi: 10.2196/25493.
- Derived from this study: PubMed 31969363Brandberg H, Kahan T, Spaak J, Sundberg K, Koch S, Adeli A, Sundberg CJ, Zakim D. A prospective cohort study of self-reported computerised medical history taking for acute chest pain: protocol of the CLEOS-Chest Pain Danderyd Study (CLEOS-CPDS). BMJ Open. 2020 Jan 21;10(1):e031871. doi: 10.1136/bmjopen-2019-031871.
- 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.
Thomas Kahan, MD, PhD study chair
Karolinska Institutet
Helge Brandberg, MD study director
Karolinska Institutet
Sabine Koch, PhD study director
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chest Pain and Acute Coronary Syndrome, run by Karolinska Institutet at 1 site in Sweden.
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 5 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 4 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 1 site in Sweden. 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?
This study is still under way. Results are not available in the source record yet.
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?
A correct diagnosis of an acute coronary syndrome by use of computer-assisted patient entered history or standard history obtained by the cardiologist in attendance (time frame: 7 days). 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 NCT03439449, which also lists 8 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 4 Mar 2025.