IschemiaNIRVANANCT02962154
Neurocardiac Interactions Evaluated by Anatomic and Physiologic MRI Assessment
An observational study of Ischemia and Stress, Mental, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The purpose of project is to answer fundamental questions about the mechanisms underlying mental stress ischemia in patients with coronary artery disease, mood disorders, or both, and to identify potential biomarkers and psychosocial risk factors associated with this condition. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Ischemia, Stress, Mental
- What is being tested?
- Coronary CT Angiography, Mood Symptom Scale and Anxiety Symptom Scale
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Jan 2018
- Phase
- Observational
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will enroll male and female subjects 50 years of age or older who have: 1. recently sustained a myocardial infarction 2. undergone or are undergoing non-emergent invasive coronary angiography (with and without known coronary artery disease) 3. a diagnosis of major depressive disorder; and a diagnosis of bipolar 1 or bipolar 2 disorder
Who may be able to join
- Male and female subjects, ages 50 years or more
- Able to provide informed consent. Must be fluent english speakers.
- Known coronary artery disease (CAD) as defined by prior PCI, CABG, prior MI, prior abnormal stress test or invasive coronary angiography (ICA)
- Patients that are hemodynamically stable
- Male and female subjects, ages 50 years or more
- Must be fluent English-speakers due to the design of the mental stress tasks. Able to provide informed consent.
- Subjects who are stable and meet DSM-V criteria for a diagnosis of major depressive disorder, bipolar 1 disorder, or bipolar 2 disorder, as assessed in an initial screening interview by phone and confirmed by a structured clinical interview on the first day of the study.
Who cannot join
- Evidence of ongoing myocardial infarction or homonymic instability
- Positive pregnancy test or unknown pregnant state at the time of enrollment for all women of child-bearing potential
- Known contraindications to cardiovascular CT angiography with intravenous contrast (A) Known allergies (B) Renal dysfunction (GFR < 30ml/min) (C) Contraindications to beta-blockers or nitroglycerin or adenosine (D) Irregular heart rate not controlled by administration of beta-blockers
- Patients with contraindications to MRI scans (A) Non-MR compatible device or material implant (B) Known allergies to gadolinium containing contrast agent (C) Renal dysfunction (GFR < 30 ml/min)
- Subjects with a history of seizure disorder, stroke, Parkinson's disease, any form of dementia, or head injury resulting in loss of consciousness will be excluded from this study.
- Contraindications to MRI be assessed during the screening interview and again using the NY-Presbyterian Hospital MRI Checklist prior to scanning and will also serve as exclusion criteria. They include claustrophobia; a history of metal implants (including braces, orthopedic implant, cochlear implant, implanted cardiac pacemaker, implanted cardioverter defibrillator, and ocular implant); weight over 250 pounds (owing to the size of the MR scanner bore); and women who are currently pregnant or breastfeeding.
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- Subjects who indicate that there is a chance that they may be pregnant will be asked to take a pregnancy test. They will be informed of the potential for false positive results due to diet, vitamins, and supplements, or over-the-counter medications. A positive pregnancy test will necessitate exclusion from the study, and the results will be disclosed to the participant.
- Patients who are currently being treated with a beta blocker or daily (standing) benzodiazepines will be excluded, unless, in the judgment of the prescribing physician, the dose can be withheld on the morning of the each study session, due to the potential for these medications to mask neurobiological and cardiovascular responses to mental stress.
- Investigators will also assess for additional psychiatric exclusion criteria during the screening interview and structured clinical interview: patients with bipolar 1 disorder who are currently manic; patients with any mood disorder currently complicated by hallucinations, delusions, or other psychotic features; patients with active suicidal ideation; and patients meeting DSM-V criteria for a co-morbid substance abuse disorder within the last 12 months will all be excluded. Other psychiatric co-morbidities will be permitted.
- Subjects who meet both the psychiatric and cardiac inclusion criteria will also be enrolled in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10021
About this study
The purpose of project is to answer fundamental questions about the mechanisms underlying mental stress ischemia in patients with coronary artery disease, mood disorders, or both, and to identify potential biomarkers and psychosocial risk factors associated with this condition.
To achieve this goal, investigators will use cutting-edge cardiovascular and functional neuroimaging tools to study mental stress ischemia in a carefully controlled laboratory setting in subjects recruited from four patient populations: 1) patients who recently sustained a myocardial infarction; 2) patients undergoing non-emergent invasive coronary angiography (with and without known coronary artery disease); 3) patients with a diagnosis of major depressive disorder; and 4) patients with a diagnosis of bipolar 1 or bipolar 2 disorder.
Read the detailed description
Mental stress ischemia occurs when a psychosocial or mental stressor triggers an imbalance between the supply and demand for oxygen by cardiac myocytes. Epidemiological studies indicate that mental stress ischemia is common, occurring in 20-25% of patients with coronary artery disease (CAD) and portends a poor prognosis. The underlying mechanisms are thought to involve stress-induced activation of the sympathetic nervous system and associated effects on cardiovascular function. But how neurobiological and cardiovascular factors interact to generate mental stress ischemia is unknown. Furthermore, patients with major depressive disorder, bipolar disorder, and other stress-related psychiatric conditions have elevated rates of cardiovascular co-morbidities, including sudden cardiac death, yet mental stress ischemia has not been studied extensively in these psychiatric populations. The purpose of project is to answer fundamental questions about the mechanisms underlying mental stress ischemia in patients with coronary artery disease, mood disorders, or both, and to identify potential biomarkers and psychosocial risk factors associated with this condition.
To achieve this goal, investigators will use cutting-edge cardiovascular and functional neuroimaging tools to study mental stress ischemia in a carefully controlled laboratory setting in subjects recruited from four patient populations: 1) patients who recently sustained a myocardial infarction; 2) patients undergoing non-emergent invasive coronary angiography (with and without known coronary artery disease); 3) patients with a diagnosis of major depressive disorder; and 4) patients with a diagnosis of bipolar 1 or bipolar 2 disorder.
- Conditions
- Ischemia, Stress, Mental
- Being tested
- Coronary CT Angiography, Mood Symptom Scale, Anxiety Symptom Scale, Chronic Stress Inventories, Psychosocial Function Questionnaires
- Keywords
- Invasive Coronary Angiography, Myocardial Infarction, Major Depressive Disorder, Bipolar I Disorder, Bipolar II Disorder, Mental Stress
- Medical subject headings
- Ischemia, Stress, Psychological, Myocardial Infarction, Depressive Disorder, Major, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary CT AngiographyRadiation
The coronary CT angiography will assess for coronary artery stenosis, plaque characteristics, calcifications, and other factors.
Mood Symptom ScaleOther
Some or all of the following questionnaires will be conducted to assess mood symptoms:
Beck Depression Inventory, Hamilton Depression Rating Scale (24-item), Montgomery Asberg Depression Rating Scale (MADRS), Mood and Anxiety Symptom Questionnaire (MASQ), QIDS, Young Mania Rating Scale
Anxiety Symptom ScaleOther
Some or all of the following questionnaires will be conducted to assess anxiety symptoms:
Beck Anxiety Inventory, Spielberger State/Trait Anxiety Inventory (STAI), GAD-7 Anxiety Questionnaire, Penn State Worry Questionnaire (PSWQ)
Chronic Stress InventoriesOther
Some of all of the following questionnaires will be conducted to assess chronic stress:
Chronic stress inventories: Cohen Perceived Stress Scale, Holmes and Rahe Stressful Life Events Scale, Karasek Job Strain Questionnaire, Conner-Davidson Resilience Scale, PTSD Checklist
Psychosocial Function QuestionnairesOther
Some of all of the following questionnaires will be conducted to assess psychosocial function:
Type A Personality Scale, NEO Personality Inventory, Positive and Negative Affect Schedule (PANAS), Behavioral Inhibition/Behavioral Approach Scale (BIS/BAS)
General Health and quality of life questionnairesOther
Some of all of the following questionnaires will be conducted to assess quality of life:
EQ-5D Health Questionnaire, Seattle Angina Questionnaire, International Index of Erectile Function (ILEF-5), Pittsburgh Sleep Quality Scale, Morningness Eveningness Questionnaire
Magnetic Resonance ImagingOther
First, subjects will undergo a resting cardiac MR perfusion study to establish baseline (pre-stress) measures of cardiovascular function. Second, subjects will undergo a series of brain magnetic resonance imaging studies (T1-weighted anatomical MRI, diffusion tensor imaging, resting state functional MRI) to establish baseline (pre-stress) measures of brain function and structural correlates. Third, investigators will use a well-validated cognitive task to induce mental stress by testing subjects' working memory for a series of emotionally arousing or neutral images, while repeating the functional MRI scan. Finally, subjects will undergo a repeat cardiac MR perfusion study while being tested on the same mental stress task.
| Study group | Role | What they receive |
|---|---|---|
| Coronary Artery Disease (CAD) | Patients with known coronary artery disease (CAD) as defined by prior PCI, CABG, prior MI, prior abnormal stress test, or invasive coronary angiography (ICA) and who are hemodynamically stable
They will undergo the following:
Radiation: Coronary CT Angiography Other: Mood Symptom Scale Other: Anxiety Symptom Scale Other: Chronic Stress Inventories Other: Psychosocial Function Questionnaires Other: General Health and quality of life questionnaires Other: Magnetic Resonance Imaging Receives: Radiation: Coronary CT Angiography; Other: Mood Symptom Scale; Other: Anxiety Symptom Scale; Other: Chronic Stress Inventories; Other: Psychosocial Function Questionnaires; Other: General Health and quality of life questionnaires; Other: Magnetic Resonance Imaging | |
| Major Depressive Disorder | Patients with a diagnosis of major depressive disorder and/or a diagnosis of bipolar 1 or bipolar 2 disorder
They will undergo the following:
Radiation: Coronary CT Angiography Other: Mood Symptom Scale Other: Anxiety Symptom Scale Other: Chronic Stress Inventories Other: Psychosocial Function Questionnaires Other: General Health and quality of life questionnaires Other: Magnetic Resonance Imaging Receives: Radiation: Coronary CT Angiography; Other: Mood Symptom Scale; Other: Anxiety Symptom Scale; Other: Chronic Stress Inventories; Other: Psychosocial Function Questionnaires; Other: General Health and quality of life questionnaires; Other: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of mental stress induced ischemia as measured by cardiac MRI
Subjects will undergo a brief training program for low-stress version of emotion regulation task and working memory task on a laptop. Baseline (non-stress) resting cardiac MR perfusion and baseline (non-stress) brain MRI studies. In addition to a mental stress task brain fMRI and mental stress cardiac MR perfusion. We can analyze the prevalence of mental stress induced ischemia.
Measured: 2 weeks
Secondary outcomes (1)
Change in cardiac stress perfusion as measured by cardiac MRI (pre and post mental stress)
We will test for within-subject changes in cardiovascular function and neural activity in stress-sensitive brain circuits, comparing pre and post-stress cardiac mRI and brain MRI studies.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study startFeb 2016
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Why it stopped: Our physician researcher left WCM after the trial was approved.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IschemiaStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James K Min, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02962154
- Sponsor's protocol ID
- 1405015093
- Acronym
- NIRVANA
- Status last verified
- Jan 2018
- First submitted
- 20 Apr 2015
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocardiac Interactions Evaluated by Anatomic and Physiologic MRI Assessment
- ClinicalTrials.gov ID
- NCT02962154
- Acronym / sponsor ID
- NIRVANA / 1405015093
- Conditions
- Ischemia, Stress, Mental
- Keywords
- Invasive Coronary Angiography, Myocardial Infarction, Major Depressive Disorder, Bipolar I Disorder, Bipolar II Disorder, Mental Stress
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Our physician researcher left WCM after the trial was approved.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 11 Nov 2016 (estimated)
- 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 purpose of project is to answer fundamental questions about the mechanisms underlying mental stress ischemia in patients with coronary artery disease, mood disorders, or both, and to identify potential biomarkers and psychosocial risk factors associated with this condition.
To achieve this goal, investigators will use cutting-edge cardiovascular and functional neuroimaging tools to study mental stress ischemia in a carefully controlled laboratory setting in subjects recruited from four patient populations: 1) patients who recently sustained a myocardial infarction; 2) patients undergoing non-emergent invasive coronary angiography (with and without known coronary artery disease); 3) patients with a diagnosis of major depressive disorder; and 4) patients with a diagnosis of bipolar 1 or bipolar 2 disorder.
Detailed description
Mental stress ischemia occurs when a psychosocial or mental stressor triggers an imbalance between the supply and demand for oxygen by cardiac myocytes. Epidemiological studies indicate that mental stress ischemia is common, occurring in 20-25% of patients with coronary artery disease (CAD) and portends a poor prognosis. The underlying mechanisms are thought to involve stress-induced activation of the sympathetic nervous system and associated effects on cardiovascular function. But how neurobiological and cardiovascular factors interact to generate mental stress ischemia is unknown. Furthermore, patients with major depressive disorder, bipolar disorder, and other stress-related psychiatric conditions have elevated rates of cardiovascular co-morbidities, including sudden cardiac death, yet mental stress ischemia has not been studied extensively in these psychiatric populations. The purpose of project is to answer fundamental questions about the mechanisms underlying mental stress ischemia in patients with coronary artery disease, mood disorders, or both, and to identify potential biomarkers and psychosocial risk factors associated with this condition.
To achieve this goal, investigators will use cutting-edge cardiovascular and functional neuroimaging tools to study mental stress ischemia in a carefully controlled laboratory setting in subjects recruited from four patient populations: 1) patients who recently sustained a myocardial infarction; 2) patients undergoing non-emergent invasive coronary angiography (with and without known coronary artery disease); 3) patients with a diagnosis of major depressive disorder; and 4) patients with a diagnosis of bipolar 1 or bipolar 2 disorder.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coronary Artery Disease (CAD) | – | Radiation: Coronary CT Angiography, Other: Mood Symptom Scale, Other: Anxiety Symptom Scale, Other: Chronic Stress Inventories, Other: Psychosocial Function Questionnaires, Other: General Health and quality of life questionnaires, Other: Magnetic Resonance ImagingPatients with known coronary artery disease (CAD) as defined by prior PCI, CABG, prior MI, prior abnormal stress test, or invasive coronary angiography (ICA) and who are hemodynamically stable They will undergo the following: Radiation: Coronary CT Angiography Other: Mood Symptom Scale Other: Anxiety Symptom Scale Other: Chronic Stress Inventories Other: Psychosocial Function Questionnaires Other: General Health and quality of life questionnaires Other: Magnetic Resonance Imaging |
| Major Depressive Disorder | – | Radiation: Coronary CT Angiography, Other: Mood Symptom Scale, Other: Anxiety Symptom Scale, Other: Chronic Stress Inventories, Other: Psychosocial Function Questionnaires, Other: General Health and quality of life questionnaires, Other: Magnetic Resonance ImagingPatients with a diagnosis of major depressive disorder and/or a diagnosis of bipolar 1 or bipolar 2 disorder They will undergo the following: Radiation: Coronary CT Angiography Other: Mood Symptom Scale Other: Anxiety Symptom Scale Other: Chronic Stress Inventories Other: Psychosocial Function Questionnaires Other: General Health and quality of life questionnaires Other: Magnetic Resonance Imaging |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll male and female subjects 50 years of age or older who have: 1. recently sustained a myocardial infarction 2. undergone or are undergoing non-emergent invasive coronary angiography (with and without known coronary artery disease) 3. a diagnosis of major depressive disorder; and a diagnosis of bipolar 1 or bipolar 2 disorder
Key inclusion criteria (7 listed)
- Male and female subjects, ages 50 years or more
- Able to provide informed consent. Must be fluent english speakers.
- Known coronary artery disease (CAD) as defined by prior PCI, CABG, prior MI, prior abnormal stress test or invasive coronary angiography (ICA)
- Patients that are hemodynamically stable
- Male and female subjects, ages 50 years or more
Key exclusion criteria (10 listed)
- Evidence of ongoing myocardial infarction or homonymic instability
- Positive pregnancy test or unknown pregnant state at the time of enrollment for all women of child-bearing potential
- Known contraindications to cardiovascular CT angiography with intravenous contrast (A) Known allergies (B) Renal dysfunction (GFR < 30ml/min) (C) Contraindications to beta-blockers or nitroglycerin or adenosine (D) Irregular heart rate not controlled by administration of beta-blockers
- Patients with contraindications to MRI scans (A) Non-MR compatible device or material implant (B) Known allergies to gadolinium containing contrast agent (C) Renal dysfunction (GFR < 30 ml/min)
- Subjects with a history of seizure disorder, stroke, Parkinson's disease, any form of dementia, or head injury resulting in loss of consciousness will be excluded from this study.
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 |
|---|---|---|
| Coronary CT AngiographyThe coronary CT angiography will assess for coronary artery stenosis, plaque characteristics, calcifications, and other factors. | Radiation | Coronary Artery Disease (CAD), Major Depressive Disorder |
| Mood Symptom ScaleSome or all of the following questionnaires will be conducted to assess mood symptoms: Beck Depression Inventory, Hamilton Depression Rating Scale (24-item), Montgomery Asberg Depression Rating Scale (MADRS), Mood and Anxiety Symptom Questionnaire (MASQ), QIDS, Young Mania Rating Scale | Other | Coronary Artery Disease (CAD), Major Depressive Disorder |
| Anxiety Symptom ScaleSome or all of the following questionnaires will be conducted to assess anxiety symptoms: Beck Anxiety Inventory, Spielberger State/Trait Anxiety Inventory (STAI), GAD-7 Anxiety Questionnaire, Penn State Worry Questionnaire (PSWQ) | Other | Coronary Artery Disease (CAD), Major Depressive Disorder |
| Chronic Stress InventoriesSome of all of the following questionnaires will be conducted to assess chronic stress: Chronic stress inventories: Cohen Perceived Stress Scale, Holmes and Rahe Stressful Life Events Scale, Karasek Job Strain Questionnaire, Conner-Davidson Resilience Scale, PTSD Checklist | Other | Coronary Artery Disease (CAD), Major Depressive Disorder |
| Psychosocial Function QuestionnairesSome of all of the following questionnaires will be conducted to assess psychosocial function: Type A Personality Scale, NEO Personality Inventory, Positive and Negative Affect Schedule (PANAS), Behavioral Inhibition/Behavioral Approach Scale (BIS/BAS) | Other | Coronary Artery Disease (CAD), Major Depressive Disorder |
| General Health and quality of life questionnairesSome of all of the following questionnaires will be conducted to assess quality of life: EQ-5D Health Questionnaire, Seattle Angina Questionnaire, International Index of Erectile Function (ILEF-5), Pittsburgh Sleep Quality Scale, Morningness Eveningness Questionnaire | Other | Coronary Artery Disease (CAD), Major Depressive Disorder |
| Magnetic Resonance ImagingFirst, subjects will undergo a resting cardiac MR perfusion study to establish baseline (pre-stress) measures of cardiovascular function. Second, subjects will undergo a series of brain magnetic resonance imaging studies (T1-weighted anatomical MRI, diffusion tensor imaging, resting state functional MRI) to establish baseline (pre-stress) measures of brain function and structural correlates. Third, investigators will use a well-validated cognitive task to induce mental stress by testing subjects' working memory for a series of emotionally arousing or neutral images, while repeating the functional MRI scan. Finally, subjects will undergo a repeat cardiac MR perfusion study while being tested on the same mental stress task. | Other | Coronary Artery Disease (CAD), Major Depressive Disorder |
Primary outcome
Prevalence of mental stress induced ischemia as measured by cardiac MRI
Time frame: 2 weeks
Subjects will undergo a brief training program for low-stress version of emotion regulation task and working memory task on a laptop. Baseline (non-stress) resting cardiac MR perfusion and baseline (non-stress) brain MRI studies. In addition to a mental stress task brain fMRI and mental stress cardiac MR perfusion. We can analyze the prevalence of mental stress induced ischemia.
1 secondary outcome
Change in cardiac stress perfusion as measured by cardiac MRI (pre and post mental stress)
Time frame: 2 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
- Individual participant dataSharing planned: Undecided
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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.
James K Min, MD principal investigator
Weill Medical College of Cornell University
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 Ischemia and Stress, Mental, run by Weill Medical College of Cornell University at 1 site in United States.
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 7 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: withdrawn, as of the sponsor's last update on 9 Jan 2018. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Prevalence of mental stress induced ischemia as measured by cardiac MRI (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2018.