Acute Coronary SyndromeNCT04044391
Use of Magnetocardiography in Evaluation of Patients Going for Cardiac Catheterization
An observational study of Acute Coronary Syndrome and Coronary Artery Stenosis, run by Genetesis Inc. at 2 sites in United States.
Trial summary
This is a multicenter, prospective trial to measure the test performance characteristics of the Magnetocardiography (MCG) CardioFlux cardiac diagnostic system in detecting clinically significant coronary artery obstruction in patients with symptoms of suspected acute coronary syndrome or who present with a failed… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Coronary Artery Stenosis, Myocardial Ischemia
- What is being tested?
- CardioFlux Magnetocardiograph
- How many people
- 101 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 May 2019to 4 May 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This research study will enroll patients who will undergo cardiac catheterization because of symptoms and risk factors suggestive of acute coronary syndrome, and high risk patients presenting for cardiac catheterization due to an abnormal stress test. Patients meeting these criteria, and over the age of 18 years and all genders will be candidates.
Who may be able to join
- Age ≥ 18 years of age at the time of enrollment.
- Patient presenting acutely with signs and symptoms suggestive of Acute Coronary Syndrome (ACS) and in the opinion of the treating physician and based on best clinical assessment that a cardiac catheterization will be performed; or, had a positive stress test and is scheduled for cardiac catheterization.
- Patient's ability to lay supine for five minutes.
Who cannot join
- Age < 18 years of age
- Patients unable to fit into device
- Unable to transfer to device gantry
- Positive response on magnetocardiography (MCG) prescreening form
- Patients with claustrophobia or unable to lie supine for five minutes
- Pregnant women
Show all 12Show fewer
- Poor candidate for follow-up (e.g. no access to phone)
- Repeat participants
- Prisoners
- Acute STEMI or hemodynamically unstable patients (Mean Arterial Pressure ≤ 65, Respiratory Rate ≥24, Heart Rate ≥105 bpm, Temperature>38.1 or <34 degrees Celsius, O2 Saturation<90% despite oxygen therapy).
- Do not resuscitate order (DNR)
- Unable to have a cardiac catheterization secondary to dye, allergy, creatinine clearance, can't obtain access, etc.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ascension St. John Medical Center
Detroit, Michigan, 48236
Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
Official title: Noninvasive Magnetocardiography Using the CardioFlux (TM) System in the Evaluation of Acute Coronary Syndrome Patients Going for Cardiac Catheterization
This is a multicenter, prospective trial to measure the test performance characteristics of the Magnetocardiography (MCG) CardioFlux cardiac diagnostic system in detecting clinically significant coronary artery obstruction in patients with symptoms of suspected acute coronary syndrome or who present with a failed stress test with the intention of treat with cardiac catheterization.
Read the detailed description
This is a multicenter, prospective clinical trial studying the utility and accuracy of magnetocardiography (MCG) in identifying critical coronary artery obstruction responsible for myocardial ischemia. The study will enroll up to 1500 patients at high risk for coronary artery disease (CAD) who have been referred for cardiac catheterization. These patients will be recruited from an inpatient service post admission for chest pain or anginal equivalent or from a cohort of symptomatic patients who have failed outpatient stress testing. If they meet other stated inclusion criteria, they will have a 2 minute MCG scan prior to their cardiac catheterization. For comparative purposes, the first 300 patients will have an electrocardiogram (ECG) performed within 60 minutes of this initial scan.
After an enrolled study subject has had their catheterization procedure, the results of the catheterization will be reviewed by one of the study's primary investigators. If the subject has had a percutaneous coronary intervention (PCI), a second MCG scan will be performed prior to their discharge. The MCG scans will be interpreted by 3 physicians trained to read these images and blinded to all clinical information regarding study subjects.
The initial MCG scan will be evaluated for its sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and overall accuracy in detecting myocardial ischemia and critical coronary stenosis based on angiographic imaging, fractional flow reserve (FFR), or instant wave-free ratio (iFR) measurements, as applicable. The same statistical analysis will be performed for the ECGs performed on each of the applicable study subjects. When performed, the second MCG will be evaluated for any abnormalities after revascularization. These results will be used to determine the value of post-PCI MCG to predict 30 day and 180 day major adverse cardiac events (MACE)-specifically myocardial infarction or stroke, need for revascularization, or cardiac related death.
- Being tested
- CardioFlux Magnetocardiograph
- Keywords
- Coronary Artery Disease, Myocardial ischemia
- Medical subject headings
- Acute Coronary Syndrome, Coronary Stenosis, Myocardial Ischemia, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioFlux MagnetocardiographDiagnostic test
CardioFlux is a noninvasive diagnostic modality which can measure and image the heart's intrinsic magnetic field created by ion transit across cardiac cell membranes.
| Study group | Role | What they receive |
|---|---|---|
| Intention to Treat: Cardiac Catheterization | All patients meeting inclusion criteria and scheduled to undergo cardiac catheterization will undergo a CardioFlux magnetocardiogram (MCG) to determine presence of patterns which indicate myocardial ischemia. Receives: Diagnostic Test: CardioFlux Magnetocardiograph | |
| Post Percutaneous Coronary Intervention | All patients found to have significant coronary artery obstruction seen via angiography +/- fractional flow reserve (FFR) or instant wave-free ratio (iFR) and who receive a catheter based intervention will have a post-procedure CardioFlux MCG scan. Follow up over the next 30 and 180 days will be performed to determine if a persistent pattern suggesting residual ischemia will correlate with an increased incidence of major cardiac adverse events (MACE). Receives: Diagnostic Test: CardioFlux Magnetocardiograph |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of MCG to detect myocardial ischemia as determined by cardiac catheterization
Assess accuracy of CardioFlux MCG (MCG-CF) and magnetic field map characteristics with findings of significant coronary artery stenosis ≥70% via angiography and/or via FFR of <0.8 or via instant wave-free ratio (iFR) .
Measured: 72 hours
Accuracy of MCG vs. ECG
Compare CardioFlux MCG accuracy to ECG accuracy in identifying cardiac ischemia using coronary angiography with or without FFR/iFR as gold standard.
Measured: 72 hours
Secondary outcomes (2)
Incident of post-PCI MACE
Determine if residual abnormalities on post PCI MCG-CF maps can predict 30 day and 180 day MACE.
Measured: 6 months
Inter-reader reliability percentage
Measurement of consistency of interpretation among 3 physician readers of CardioFlux MCG scans.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start15 May 2019
- Primary completion1 Mar 2020
- Study completion4 May 2020
Why it stopped: Study was defunded.
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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genetesis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claire Pearson, M.D., Principal investigator, Ascension St, John Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04044391
- Sponsor's protocol ID
- 1345773
- Status last verified
- May 2020
- First submitted
- 1 Aug 2019
- Last updated
- 26 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to make individual patient data (IPD) available to researchers not affiliated with the centers enrolling patients within this trial.
Publications
Chaikovsky I, Hailer B, Sosnytskyy V, Lutay M, Mjasnikov G, Kazmirchuk A, Bydnyk M, Lomakovskyy A, Sosnytskaja T. Predictive value of the complex magnetocardiographic index in patients with intermediate pretest probability of chronic coronary artery disease: results of a two-center study. Coron Artery Dis. 2014 Sep;25(6):474-84. doi: 10.1097/MCA.0000000000000107.
PubMed 24667125Chen T, Z., C., Jiang, S, Van Leeuwen, P., Gronemeyer, D, Noninvasively diagnosing coronary artery disease with 61 channel MCG data. Chinese Science Bulletin. , 2014. 59: p. 1123.
Hailer B, Chaikovsky I, Auth-Eisernitz S, Schafer H, Van Leeuwen P. The value of magnetocardiography in patients with and without relevant stenoses of the coronary arteries using an unshielded system. Pacing Clin Electrophysiol. 2005 Jan;28(1):8-16. doi: 10.1111/j.1540-8159.2005.09318.x.
PubMed 15660796Park JW, Hill PM, Chung N, Hugenholtz PG, Jung F. Magnetocardiography predicts coronary artery disease in patients with acute chest pain. Ann Noninvasive Electrocardiol. 2005 Jul;10(3):312-23. doi: 10.1111/j.1542-474X.2005.00634.x.
PubMed 16029382Lim HK, Kwon H, Chung N, Ko YG, Kim JM, Kim IS, Park YK. Usefulness of magnetocardiogram to detect unstable angina pectoris and non-ST elevation myocardial infarction. Am J Cardiol. 2009 Feb 15;103(4):448-54. doi: 10.1016/j.amjcard.2008.10.013. Epub 2008 Dec 25.
PubMed 19195500Li Y, Che Z, Quan W, Yuan R, Shen Y, Liu Z, Wang W, Jin H, Lu G. Diagnostic outcomes of magnetocardiography in patients with coronary artery disease. Int J Clin Exp Med. 2015 Feb 15;8(2):2441-6. eCollection 2015.
PubMed 25932186Kwong JS, Leithauser B, Park JW, Yu CM. Diagnostic value of magnetocardiography in coronary artery disease and cardiac arrhythmias: a review of clinical data. Int J Cardiol. 2013 Sep 1;167(5):1835-42. doi: 10.1016/j.ijcard.2012.12.056. Epub 2013 Jan 19.
PubMed 23336954Agarwal R, Saini A, Alyousef T, Umscheid CA. Magnetocardiography for the diagnosis of coronary artery disease: a systematic review and meta-analysis. Ann Noninvasive Electrocardiol. 2012 Oct;17(4):291-8. doi: 10.1111/j.1542-474X.2012.00538.x. Epub 2012 Aug 13.
PubMed 23094875Kwon H, Kim K, Lee YH, Kim JM, Yu KK, Chung N, Ko YG. Non-invasive magnetocardiography for the early diagnosis of coronary artery disease in patients presenting with acute chest pain. Circ J. 2010 Jul;74(7):1424-30. doi: 10.1253/circj.cj-09-0975. Epub 2010 May 27.
PubMed 20508380Tolstrup K, Madsen BE, Ruiz JA, Greenwood SD, Camacho J, Siegel RJ, Gertzen HC, Park JW, Smars PA. Non-invasive resting magnetocardiographic imaging for the rapid detection of ischemia in subjects presenting with chest pain. Cardiology. 2006;106(4):270-6. doi: 10.1159/000093490. Epub 2006 May 29.
PubMed 16733351
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Magnetocardiography Using the CardioFlux (TM) System in the Evaluation of Acute Coronary Syndrome Patients Going for Cardiac Catheterization
- ClinicalTrials.gov ID
- NCT04044391
- Acronym / sponsor ID
- 1345773
- Keywords
- Coronary Artery Disease, Myocardial ischemia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study was defunded.
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Genetesis Inc.Industry (pharma, biotech, devices)
- Study start
- 15 May 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 4 May 2020 (actual)
- First posted
- 5 Aug 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.
This is a multicenter, prospective trial to measure the test performance characteristics of the Magnetocardiography (MCG) CardioFlux cardiac diagnostic system in detecting clinically significant coronary artery obstruction in patients with symptoms of suspected acute coronary syndrome or who present with a failed stress test with the intention of treat with cardiac catheterization.
Detailed description
This is a multicenter, prospective clinical trial studying the utility and accuracy of magnetocardiography (MCG) in identifying critical coronary artery obstruction responsible for myocardial ischemia. The study will enroll up to 1500 patients at high risk for coronary artery disease (CAD) who have been referred for cardiac catheterization. These patients will be recruited from an inpatient service post admission for chest pain or anginal equivalent or from a cohort of symptomatic patients who have failed outpatient stress testing. If they meet other stated inclusion criteria, they will have a 2 minute MCG scan prior to their cardiac catheterization. For comparative purposes, the first 300 patients will have an electrocardiogram (ECG) performed within 60 minutes of this initial scan.
After an enrolled study subject has had their catheterization procedure, the results of the catheterization will be reviewed by one of the study's primary investigators. If the subject has had a percutaneous coronary intervention (PCI), a second MCG scan will be performed prior to their discharge. The MCG scans will be interpreted by 3 physicians trained to read these images and blinded to all clinical information regarding study subjects.
The initial MCG scan will be evaluated for its sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and overall accuracy in detecting myocardial ischemia and critical coronary stenosis based on angiographic imaging, fractional flow reserve (FFR), or instant wave-free ratio (iFR) measurements, as applicable. The same statistical analysis will be performed for the ECGs performed on each of the applicable study subjects. When performed, the second MCG will be evaluated for any abnormalities after revascularization. These results will be used to determine the value of post-PCI MCG to predict 30 day and 180 day major adverse cardiac events (MACE)-specifically myocardial infarction or stroke, need for revascularization, or cardiac related death.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intention to Treat: Cardiac Catheterization | – | Diagnostic Test: CardioFlux MagnetocardiographAll patients meeting inclusion criteria and scheduled to undergo cardiac catheterization will undergo a CardioFlux magnetocardiogram (MCG) to determine presence of patterns which indicate myocardial ischemia. |
| Post Percutaneous Coronary Intervention | – | Diagnostic Test: CardioFlux MagnetocardiographAll patients found to have significant coronary artery obstruction seen via angiography +/- fractional flow reserve (FFR) or instant wave-free ratio (iFR) and who receive a catheter based intervention will have a post-procedure CardioFlux MCG scan. Follow up over the next 30 and 180 days will be performed to determine if a persistent pattern suggesting residual ischemia will correlate with an increased incidence of major cardiac adverse events (MACE). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This research study will enroll patients who will undergo cardiac catheterization because of symptoms and risk factors suggestive of acute coronary syndrome, and high risk patients presenting for cardiac catheterization due to an abnormal stress test. Patients meeting these criteria, and over the age of 18 years and all genders will be candidates.
Key inclusion criteria (3 listed)
- Age ≥ 18 years of age at the time of enrollment.
- Patient presenting acutely with signs and symptoms suggestive of Acute Coronary Syndrome (ACS) and in the opinion of the treating physician and based on best clinical assessment that a cardiac catheterization will be performed; or, had a positive stress test and is scheduled for cardiac catheterization.
- Patient's ability to lay supine for five minutes.
Key exclusion criteria (12 listed)
- Age < 18 years of age
- Patients unable to fit into device
- Unable to transfer to device gantry
- Positive response on magnetocardiography (MCG) prescreening form
- Patients with claustrophobia or unable to lie supine for five minutes
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 |
|---|---|---|
| CardioFlux MagnetocardiographCardioFlux is a noninvasive diagnostic modality which can measure and image the heart's intrinsic magnetic field created by ion transit across cardiac cell membranes. | Diagnostic test | Intention to Treat: Cardiac Catheterization, Post Percutaneous Coronary Intervention |
Primary outcome
Accuracy of MCG to detect myocardial ischemia as determined by cardiac catheterization
Time frame: 72 hours
Assess accuracy of CardioFlux MCG (MCG-CF) and magnetic field map characteristics with findings of significant coronary artery stenosis ≥70% via angiography and/or via FFR of <0.8 or via instant wave-free ratio (iFR) .
Accuracy of MCG vs. ECG
Time frame: 72 hours
Compare CardioFlux MCG accuracy to ECG accuracy in identifying cardiac ischemia using coronary angiography with or without FFR/iFR as gold standard.
2 secondary outcomes
Incident of post-PCI MACE
Time frame: 6 months
Inter-reader reliability percentage
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Study was defunded.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2020.
- Background: PubMed 24667125Chaikovsky I, Hailer B, Sosnytskyy V, Lutay M, Mjasnikov G, Kazmirchuk A, Bydnyk M, Lomakovskyy A, Sosnytskaja T. Predictive value of the complex magnetocardiographic index in patients with intermediate pretest probability of chronic coronary artery disease: results of a two-center study. Coron Artery Dis. 2014 Sep;25(6):474-84. doi: 10.1097/MCA.0000000000000107.
- BackgroundChen T, Z., C., Jiang, S, Van Leeuwen, P., Gronemeyer, D, Noninvasively diagnosing coronary artery disease with 61 channel MCG data. Chinese Science Bulletin. , 2014. 59: p. 1123.
- Background: PubMed 15660796Hailer B, Chaikovsky I, Auth-Eisernitz S, Schafer H, Van Leeuwen P. The value of magnetocardiography in patients with and without relevant stenoses of the coronary arteries using an unshielded system. Pacing Clin Electrophysiol. 2005 Jan;28(1):8-16. doi: 10.1111/j.1540-8159.2005.09318.x.
- Background: PubMed 16029382Park JW, Hill PM, Chung N, Hugenholtz PG, Jung F. Magnetocardiography predicts coronary artery disease in patients with acute chest pain. Ann Noninvasive Electrocardiol. 2005 Jul;10(3):312-23. doi: 10.1111/j.1542-474X.2005.00634.x.
- Background: PubMed 19195500Lim HK, Kwon H, Chung N, Ko YG, Kim JM, Kim IS, Park YK. Usefulness of magnetocardiogram to detect unstable angina pectoris and non-ST elevation myocardial infarction. Am J Cardiol. 2009 Feb 15;103(4):448-54. doi: 10.1016/j.amjcard.2008.10.013. Epub 2008 Dec 25.
- Background: PubMed 25932186Li Y, Che Z, Quan W, Yuan R, Shen Y, Liu Z, Wang W, Jin H, Lu G. Diagnostic outcomes of magnetocardiography in patients with coronary artery disease. Int J Clin Exp Med. 2015 Feb 15;8(2):2441-6. eCollection 2015.
- Background: PubMed 23336954Kwong JS, Leithauser B, Park JW, Yu CM. Diagnostic value of magnetocardiography in coronary artery disease and cardiac arrhythmias: a review of clinical data. Int J Cardiol. 2013 Sep 1;167(5):1835-42. doi: 10.1016/j.ijcard.2012.12.056. Epub 2013 Jan 19.
- Background: PubMed 23094875Agarwal R, Saini A, Alyousef T, Umscheid CA. Magnetocardiography for the diagnosis of coronary artery disease: a systematic review and meta-analysis. Ann Noninvasive Electrocardiol. 2012 Oct;17(4):291-8. doi: 10.1111/j.1542-474X.2012.00538.x. Epub 2012 Aug 13.
- Background: PubMed 20508380Kwon H, Kim K, Lee YH, Kim JM, Yu KK, Chung N, Ko YG. Non-invasive magnetocardiography for the early diagnosis of coronary artery disease in patients presenting with acute chest pain. Circ J. 2010 Jul;74(7):1424-30. doi: 10.1253/circj.cj-09-0975. Epub 2010 May 27.
- Background: PubMed 16733351Tolstrup K, Madsen BE, Ruiz JA, Greenwood SD, Camacho J, Siegel RJ, Gertzen HC, Park JW, Smars PA. Non-invasive resting magnetocardiographic imaging for the rapid detection of ischemia in subjects presenting with chest pain. Cardiology. 2006;106(4):270-6. doi: 10.1159/000093490. Epub 2006 May 29.
- Individual participant dataSharing planned: No. There is no plan to make individual patient data (IPD) available to researchers not affiliated with the centers enrolling patients within this trial.
Related trials for Acute Coronary Syndrome
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
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.
Claire Pearson, M.D. principal investigator
Ascension St, John Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome and Coronary Artery Stenosis, run by Genetesis Inc. at 2 sites 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 3 inclusion and 12 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: stopped early, as of the sponsor's last update on 26 May 2020. 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 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 stopped early (reason given: Study was defunded.). Results are not available in the source record.
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?
Accuracy of MCG to detect myocardial ischemia as determined by cardiac catheterization (time frame: 72 hours). 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 NCT04044391, 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 26 May 2020.