Acute Coronary SyndromeMEDIMACSNCT03842319
Impact of MEditerranean Diet, Inflammation and Microbiome After an Acute Coronary Syndrome
A study testing Microbiota analysis, Immunological analysis and Proteome analysis in people with Acute Coronary Syndrome, run by Consorcio Centro de Investigación Biomédica en Red (CIBER) at 1 site in Spain.
Trial summary
In the MEDIMACS project, the investigators will use a randomized clinical-trial design to address the effects of mediterranean diet on atherosclerotic plaque vulnerability and coronary endothelial function in order to decipher complex interplays between diet, microbiome, immunological and metabolic responses and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Microbiota analysis, Immunological analysis and Proteome analysis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 14 May 2019to 2 Aug 2022
- 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
- Adult patients undergoing cardiac catheterization for an acute coronary syndrome.
- At least 1 non-causal lesion in a coronary segment with a stenosis diameter between 40-70% that will not be submitted to intervention during the revascularization procedure.
- Disposition and possibility to modify the diet.
- With the ability to track and answer questionnaires.
- Signature of informed consent for the study
Who cannot join
- TIMI score <3 in the injury
- Reference lesion with diameter <2.0 mm
- LV ejection fraction (EF) less than 45%.
- Active systemic infection
- Active periodontal disease
- Chronic inflammatory disease
Show all 10Show fewer
- Active treatment with corticosteroids or immunomodulators
- Renal insufficiency with glomerular filtration less than 30 mL / min
- Severe hepatic insufficiency (liver cirrhosis in Child B or C stages).
- Comorbidity with life expectancy of less than one year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of MEditerranean Diet, Inflammation and Microbiome on Plaque Vulnerability and Microvascular Dysfunction After an Acute Coronary Syndrome. A Randomized, Controlled, Mechanistic Clinical Trial.
In the MEDIMACS project, the investigators will use a randomized clinical-trial design to address the effects of mediterranean diet on atherosclerotic plaque vulnerability and coronary endothelial function in order to decipher complex interplays between diet, microbiome, immunological and metabolic responses and coronary atherosclerosis. The investigators will focus on patients after an episode of acute coronary syndrome and use state-of-the-art techniques to address atherosclerotic plaque composition and coronary endothelial function. A number of different -omic approaches will be used to address effector pathways. The insights provided by this study will allow identifying potential new dietary, microbiota and/or metabolic targets for the treatment of atherosclerosis
Read the detailed description
Coronary atherosclerosis is a leading cause of mortality and disability worldwide. Continuous efforts are needed to improve secondary prevention and understand the mechanism underlying disease progression. Based on primary prevention trials, a potential benefit of the Mediterranean diet after an acute coronary syndrome can be anticipated. The integrated microbiome-mediated/ immunologic and metabolic pathways by which the Mediterranean diet modifies cardiovascular risk remain mostly unknown. Intestinal and oral dysbiosis is involved in the pathogenesis of atherosclerosis and microbiome dynamics may account for some of the observed benefits of Mediterranean diet. The first objective of the trial is to evaluate the effects of a well-controlled Mediterranean diet intervention on atherosclerotic plaque vulnerability and coronary endothelial dysfunction after an episode of acute coronary syndrome. The second objective is to decipher the interplays among diet, microbiota, immunity and metabolism responsible for the observed effects. The investigators propose a randomized mechanistic clinical trial, using state-of-the-art efficacy read-outs. The multidisciplinary consortium includes highly experienced cardiologists, nutritionists and experts in translational research in immunology, microbiomics, genomics, proteomics, metabolomics and metagenomics. This study will provide valuable insights to identify potential microbiome therapeutic targets for coronary artery disease.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Microbiota analysis, Immunological analysis, Proteome analysis, Metabolome analysis, Clinical evaluation
- Keywords
- Atherosclerosis, Mediterranean diet, microbiota, immune system, metabolome, proteome
- Medical subject headings
- Acute Coronary Syndrome, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbiota analysisOther
From the feces and oral cavity samples, the DNA of the microbiota will be extracted using specific extraction kits and the microbiome will be analyzed through the study of 16S ribosomal RNA amplicons.
Immunological analysisOther
A study of immunological cell populations, inmunogenetics and cytokines will be carried out from fresh blood samples using antibody panels and flow cytometry
Proteome analysisOther
A study of host and microbiota proteome will be carried out from samples using mass spectrometry
Metabolome analysisOther
A study of host and microbiota metabolome will be carried out from samples using MS-based as well as NMR-based methods
Clinical evaluationOther
Clinical evaluation including hemostasis and biochemical studies
Diet evaluationOther
Biochemical analysis and questionaries for diet adherence and exercise registration
MedDietOther
The high-intensity Mediterranean diet will include the promotion of the following: a) abundant use of olive oil (>40 g/d) for cooking and dressing dishes; b) consumption of >2 daily servings of vegetables; c) >2-3 daily serving of fresh fruits; d) >3 weekly servings of legumes; e) >3 weekly servings of fish or seafood; f) >1 weekly serving of nuts or seeds; g) select white meats instead of red meats or processed meats; and h) cook regularly with tomato, garlic and onion adding or no other aromatic herbs, and dress vegetables, pasta, rice and other dishes with tomato, garlic and onion adding or no other aromatic herbs. Two main meals per day should be eaten (seated at a table, lasting more than 20 minutes). A recommendation to drink a glass of wine per day during meals is given. Limited consumption is advised for cured ham, red meat, chocolate, cured or fatty cheeses
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | In patients allocated to the control group, the currently used Spanish Mediterranean diet will be recommended as part of a standard high-quality secondary prevention program, where the patient is invited to participate in a single 45 minute nutritional educational group session. Interventions: Microbiota analysis, Immunological analysis, Proteome analysis, Metabolome analysis, Clinical evaluation Receives: Other: Microbiota analysis; Other: Immunological analysis; Other: Proteome analysis; Other: Metabolome analysis; Other: Clinical evaluation; Other: Diet evaluation |
| High-intensity MedDiet | Experimental | Patients allocated to the interventional group will be individually evaluated by a dietitian and will participate in dedicated individual and group sessions at baseline, and at 3, 6, 9 and 12 months. In the interventional group, a personalized MedDiet will assess chemical and nutritional composition and total energy intake will be adapted to participant's weight, age, and requirements, and the dietitian's tailored advice to his/her individual needs. A 14-item dietary screen for adherence to the Mediterranean diet will be used to personalize the intervention and negotiate dietary changes. Furthermore, free virgin olive oil, recipes, shopping list and designed weekly menus will be provided to maximize the differences between groups. Interventions: MedDiet, Microbiota analysis, Immunological analysis, Proteome analysis, Metabolome analysis, Clinical evaluation, Diet evaluation Receives: Other: Microbiota analysis; Other: Immunological analysis; Other: Proteome analysis; Other: Metabolome analysis; Other: Clinical evaluation; Other: Diet evaluation; Other: MedDiet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibrous cap thickness change
Change in the thickness of the fibrous layer of the atheroma plaque in the non-culprit vessel measured by optical coherence tomography at 12 months.
Measured: 12 months
Secondary outcomes (10)
Endothelial dysfunction
Vascular endothelial function measured using a Doppler pressure guidewire
Measured: 12 months
Intestinal microbiota composition changes
Changes from baseline in intestinal microbiota will be analysed using the 16S rRNA target gene sequencing approach at 3 months, 6 months, 9 months and 12 months
Measured: 12 months
Oral microbiota composition changes
Changes from baseline in oral microbiota will be analysed using the 16S rRNA target gene sequencing approach at 3 months, 6 months, 9 months and 12 months
Measured: 12 months
Adaptive immune system status changes
Changes from baseline of adaptive immune cell lineages will be assessed dynamically using high performance cytometry at 3 months, 6 months, 9 months and 12 months
Measured: 12 months
Innate immune system status changes
Changes from baseline of innate immune cell lineages will be assessed dynamically using high performance cytometry at 3 months, 6 months, 9 months and 12 months
Measured: 12 months
Blood protein profiling changes
Changes from baseline of host protein-profiles from collected plasma samples will be analyzed for detection of biomarkers at 3 months, 6 months, 9 months and 12 months
Measured: 12 months
Faecal protein profiling changes
Changes from baseline of host protein-profiles from collected faces samples will be analyzed for detection of biomarkers at 3 months, 6 months, 9 months and 12 months
Measured: 12 months
Urine metabolome profiling changes
Changes from baseline of host metabolome profiles in urine will be analyzed using mass-spectrometry-based at 3 months, 6 months, 9 months and 12 months
Measured: 12 months
Blood metabolome profiling changes
Changes from baseline of host metabolome profiles in blood will be analyzed using mass-spectrometry-based at 3 months, 6 months, 9 months and 12 months
Measured: 12 months
Faecal metabolome profiling changes
Changes from baseline of metabolome profiles in faecal samples will be analyzed using mass-spectrometry-based at 3 months, 6 months, 9 months and 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start14 May 2019
- Primary completion2 Aug 2022
- Study completion2 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention Group: High intensity Mediterranean diet in secondary prevention after acute coronary syndrome. Control Group: recommendation of a standard of care, standard Mediterranean diet. Duration of the intervention per participant: 12 months. Follow-up period per participant: 12 months.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorcio Centro de Investigación Biomédica en Red (CIBER)
- Sponsor type
- Other government
- Collaborators
- Hospital General Universitario Gregorio Marañon, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana, University of Navarra, Institut National de la Santé Et de la Recherche Médicale, France, Tel Aviv University, Göteborg University
- Responsible party
- Sponsor
- Investigators
- Francisco Fernández-Avilés, Professor, Principal investigator, CIBER, HGUGM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03842319
- Sponsor's protocol ID
- CIBER-MEDIMACS
- Acronym
- MEDIMACS
- Status last verified
- Sep 2022
- First submitted
- 13 Feb 2019
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The Consortium Partners involved in data creation and analysis agrees to follow the FAIR data management principles of Findability, Accessibility, Interoperability and Reusability. The Project Management Committee will decide what type and format of data to be stored in the collective database and what type and format of data will be available publicly (as an open-access to research data), as well as how data will be curated and preserved after the end of the project. Sequences, genotypes and protein and immune profiles would be organized and indexed in metadata files following a unique code of assignment that will be submitted for releasing to public database repositories such as GenBank, Gene Expression Omnibus and ClinicalTrials. The International Standards for Genomes and Metagenomes will be followed
Publications
Fernandez AI, Bermejo J, Yotti R, Martinez-Gonzalez MA, Mira A, Gophna U, Karlsson R, Al-Daccak R, Martin-Demiguel I, Gutierrez-Ibanes E, Charron D, Fernandez-Aviles F; MEDIMACS research team. The impact of Mediterranean diet on coronary plaque vulnerability, microvascular function, inflammation and microbiome after an acute coronary syndrome: study protocol for the MEDIMACS randomized, controlled, mechanistic clinical trial. Trials. 2021 Nov 12;22(1):795. doi: 10.1186/s13063-021-05746-z.
PubMed 34772433
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of MEditerranean Diet, Inflammation and Microbiome on Plaque Vulnerability and Microvascular Dysfunction After an Acute Coronary Syndrome. A Randomized, Controlled, Mechanistic Clinical Trial.
- ClinicalTrials.gov ID
- NCT03842319
- Acronym / sponsor ID
- MEDIMACS / CIBER-MEDIMACS
- Conditions
- Acute Coronary Syndrome
- Keywords
- Atherosclerosis, Mediterranean diet, microbiota, immune system, metabolome, proteome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Consorcio Centro de Investigación Biomédica en Red (CIBER)Other government
- Collaborators
- Hospital General Universitario Gregorio Marañon, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana, University of Navarra, Institut National de la Santé Et de la Recherche Médicale, France, Tel Aviv University, Göteborg University
- Study start
- 14 May 2019 (actual)
- Primary completion
- 2 Aug 2022 (actual)
- Study completion
- 2 Aug 2022 (actual)
- First posted
- 15 Feb 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.
In the MEDIMACS project, the investigators will use a randomized clinical-trial design to address the effects of mediterranean diet on atherosclerotic plaque vulnerability and coronary endothelial function in order to decipher complex interplays between diet, microbiome, immunological and metabolic responses and coronary atherosclerosis. The investigators will focus on patients after an episode of acute coronary syndrome and use state-of-the-art techniques to address atherosclerotic plaque composition and coronary endothelial function. A number of different -omic approaches will be used to address effector pathways. The insights provided by this study will allow identifying potential new dietary, microbiota and/or metabolic targets for the treatment of atherosclerosis
Detailed description
Coronary atherosclerosis is a leading cause of mortality and disability worldwide. Continuous efforts are needed to improve secondary prevention and understand the mechanism underlying disease progression. Based on primary prevention trials, a potential benefit of the Mediterranean diet after an acute coronary syndrome can be anticipated. The integrated microbiome-mediated/ immunologic and metabolic pathways by which the Mediterranean diet modifies cardiovascular risk remain mostly unknown. Intestinal and oral dysbiosis is involved in the pathogenesis of atherosclerosis and microbiome dynamics may account for some of the observed benefits of Mediterranean diet. The first objective of the trial is to evaluate the effects of a well-controlled Mediterranean diet intervention on atherosclerotic plaque vulnerability and coronary endothelial dysfunction after an episode of acute coronary syndrome. The second objective is to decipher the interplays among diet, microbiota, immunity and metabolism responsible for the observed effects. The investigators propose a randomized mechanistic clinical trial, using state-of-the-art efficacy read-outs. The multidisciplinary consortium includes highly experienced cardiologists, nutritionists and experts in translational research in immunology, microbiomics, genomics, proteomics, metabolomics and metagenomics. This study will provide valuable insights to identify potential microbiome therapeutic targets for coronary artery disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Intervention Group: High intensity Mediterranean diet in secondary prevention after acute coronary syndrome. Control Group: recommendation of a standard of care, standard Mediterranean diet. Duration of the intervention per participant: 12 months. Follow-up period per participant: 12 months.
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Other: Microbiota analysis, Other: Immunological analysis, Other: Proteome analysis, Other: Metabolome analysis, Other: Clinical evaluation, Other: Diet evaluationIn patients allocated to the control group, the currently used Spanish Mediterranean diet will be recommended as part of a standard high-quality secondary prevention program, where the patient is invited to participate in a single 45 minute nutritional educational group session. Interventions: Microbiota analysis, Immunological analysis, Proteome analysis, Metabolome analysis, Clinical evaluation |
| High-intensity MedDiet | Experimental | Other: Microbiota analysis, Other: Immunological analysis, Other: Proteome analysis, Other: Metabolome analysis, Other: Clinical evaluation, Other: Diet evaluation, Other: MedDietPatients allocated to the interventional group will be individually evaluated by a dietitian and will participate in dedicated individual and group sessions at baseline, and at 3, 6, 9 and 12 months. In the interventional group, a personalized MedDiet will assess chemical and nutritional composition and total energy intake will be adapted to participant's weight, age, and requirements, and the dietitian's tailored advice to his/her individual needs. A 14-item dietary screen for adherence to the Mediterranean diet will be used to personalize the intervention and negotiate dietary changes. Furthermore, free virgin olive oil, recipes, shopping list and designed weekly menus will be provided to maximize the differences between groups. Interventions: MedDiet, Microbiota analysis, Immunological analysis, Proteome analysis, Metabolome analysis, Clinical evaluation, Diet evaluation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients undergoing cardiac catheterization for an acute coronary syndrome.
- At least 1 non-causal lesion in a coronary segment with a stenosis diameter between 40-70% that will not be submitted to intervention during the revascularization procedure.
- Disposition and possibility to modify the diet.
- With the ability to track and answer questionnaires.
- Signature of informed consent for the study
Key exclusion criteria (10 listed)
- TIMI score <3 in the injury
- Reference lesion with diameter <2.0 mm
- LV ejection fraction (EF) less than 45%.
- Active systemic infection
- Active periodontal disease
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 |
|---|---|---|
| Microbiota analysisFrom the feces and oral cavity samples, the DNA of the microbiota will be extracted using specific extraction kits and the microbiome will be analyzed through the study of 16S ribosomal RNA amplicons. | Other | Control, High-intensity MedDiet |
| Immunological analysisA study of immunological cell populations, inmunogenetics and cytokines will be carried out from fresh blood samples using antibody panels and flow cytometry | Other | Control, High-intensity MedDiet |
| Proteome analysisA study of host and microbiota proteome will be carried out from samples using mass spectrometry | Other | Control, High-intensity MedDiet |
| Metabolome analysisA study of host and microbiota metabolome will be carried out from samples using MS-based as well as NMR-based methods | Other | Control, High-intensity MedDiet |
| Clinical evaluationClinical evaluation including hemostasis and biochemical studies | Other | Control, High-intensity MedDiet |
| Diet evaluationBiochemical analysis and questionaries for diet adherence and exercise registration | Other | Control, High-intensity MedDiet |
| MedDietThe high-intensity Mediterranean diet will include the promotion of the following: a) abundant use of olive oil (>40 g/d) for cooking and dressing dishes; b) consumption of >2 daily servings of vegetables; c) >2-3 daily serving of fresh fruits; d) >3 weekly servings of legumes; e) >3 weekly servings of fish or seafood; f) >1 weekly serving of nuts or seeds; g) select white meats instead of red meats or processed meats; and h) cook regularly with tomato, garlic and onion adding or no other aromatic herbs, and dress vegetables, pasta, rice and other dishes with tomato, garlic and onion adding or no other aromatic herbs. Two main meals per day should be eaten (seated at a table, lasting more than 20 minutes). A recommendation to drink a glass of wine per day during meals is given. Limited consumption is advised for cured ham, red meat, chocolate, cured or fatty cheeses | Other | High-intensity MedDiet |
Primary outcome
Fibrous cap thickness change
Time frame: 12 months
Change in the thickness of the fibrous layer of the atheroma plaque in the non-culprit vessel measured by optical coherence tomography at 12 months.
10 secondary outcomes
Endothelial dysfunction
Time frame: 12 months
Intestinal microbiota composition changes
Time frame: 12 months
Oral microbiota composition changes
Time frame: 12 months
Adaptive immune system status changes
Time frame: 12 months
Innate immune system status changes
Time frame: 12 months
Blood protein profiling changes
Time frame: 12 months
Faecal protein profiling changes
Time frame: 12 months
Urine metabolome profiling changes
Time frame: 12 months
Blood metabolome profiling changes
Time frame: 12 months
Faecal metabolome profiling changes
Time frame: 12 months
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 3 Oct 2022.
- Derived from this study: PubMed 34772433Fernandez AI, Bermejo J, Yotti R, Martinez-Gonzalez MA, Mira A, Gophna U, Karlsson R, Al-Daccak R, Martin-Demiguel I, Gutierrez-Ibanes E, Charron D, Fernandez-Aviles F; MEDIMACS research team. The impact of Mediterranean diet on coronary plaque vulnerability, microvascular function, inflammation and microbiome after an acute coronary syndrome: study protocol for the MEDIMACS randomized, controlled, mechanistic clinical trial. Trials. 2021 Nov 12;22(1):795. doi: 10.1186/s13063-021-05746-z.
- Individual participant dataSharing planned: Undecided. The Consortium Partners involved in data creation and analysis agrees to follow the FAIR data management principles of Findability, Accessibility, Interoperability and Reusability. The Project Management Committee will decide what type and format of data to be stored in the collective database and what type and format of data will be available publicly (as an open-access to research data), as well as how data will be curated and preserved after the end of the project. Sequences, genotypes and protein and immune profiles would be organized and indexed in metadata files following a unique code of assignment that will be submitted for releasing to public database repositories such as GenBank, Gene Expression Omnibus and ClinicalTrials. The International Standards for Genomes and Metagenomes will be followed
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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.
Francisco Fernández-Avilés, Professor principal investigator
CIBER, HGUGM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microbiota analysis, Immunological analysis and Proteome analysis in people with Acute Coronary Syndrome, run by Consorcio Centro de Investigación Biomédica en Red (CIBER) at 1 site in Spain.
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 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 3 Oct 2022. 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 Spain. 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?
Fibrous cap thickness change (time frame: 12 months). 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 NCT03842319, which also lists 1 linked publication.
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 3 Oct 2022.