Myocardial Injury After Non-cardiac SurgeryEnhanceMINSNCT06474754
Submaximal Cardiopulmonary Exercise Testing for Detection of Myocardial Injury After Noncardiac Surgery
A study testing High-sensitivity troponin, serum, Submaximal Cardiopulmonary Exercise Testing and Duke Activity Status Index in people with Myocardial Injury After Non-cardiac Surgery and Submaximal Exercise Performance, run by Yale University at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn whether physicians can associate evidence of myocardial injury after surgery with findings obtained from submaximal cardiopulmonary exercise testing. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myocardial Injury After Non-cardiac Surgery, Submaximal Exercise Performance, Preoperative Period
- What is being tested?
- High-sensitivity troponin, serum, Submaximal Cardiopulmonary Exercise Testing and Duke Activity Status Index
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2025to 30 Apr 2026
- 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Biological male or female, aged 45 years or older.
- In good general health as evidenced by medical history or diagnosed with metabolic equivalents (self-reported ability to climb 1 flight of stairs).
- Revised Cardiac Risk Index less than or equal to three.
- Willing to accept phlebotomy on operative day 0, 1, 2, and 3, as part of usual care.
- Scheduled for moderate to high-risk elective non-cardiac surgery with an expected 24-72 hour stay within 60 days of enrollment in the study.
Who cannot join
- Inability to perform study procedures as defined by inability to achieve greater than 4 metabolic equivalents (cannot climb 1 flight of stairs reliably).
- Pregnancy or lactation.
- Inability to give independent informed consent.
- Revised cardiac risk index greater than 3.
- Recent myocardial infarction (less than 6 weeks).
- Recent anginal symptoms (stable or unstable) within past 6 months.
Show all 20Show fewer
- Recent admission or endorsement for congestive heart failure within 6 months
- Recent admission or endorsement for syncope within 6 months.
- Symptomatic tachy- or bradyarrhythmia (supraventricular tachcardia, ventricular tachycardia with symptoms of intermittent dizziness, pre- syncopal events)
- Uncorrected severe valvular heart disease (severe aortic, tricuspid or mitral stenosis)
- Acute pulmonary embolism or deep vein thrombosis (within past 6 months)
- Uncontrolled pulmonary edema
- Uncontrolled symptomatic cardiac arrhythmias.
- Active endocarditis
- Active myocarditis or pericarditis
- Active wheezing or recent exacerbation of chronic obstructive pulmonary disease admission in past 6 months.
- Inability to perform components of the SHAPE test (severe hip flexion limitation, severe osteoarthritis of knee or hip, limb immobilization, ambulation requires cane or crutches, baseline balance irregularities.
- Diagnosis of symptomatic vertigo
- Known allergic reactions to components of the SHAPE medical system apparatus disposable mouthpiece.
- Active enrollment in an interventional clinical trial within the enrollment period of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University; Yale New Haven Hospital
New Haven, Connecticut, 06510
About this study
Official title: Enhancing Precise Perioperative Risk Surveillance: Validation of Submaximal Cardiopulmonary Exercise Testing to Usual Care for Detection of Myocardial Injury After Noncardiac Surgery
The goal of this clinical trial is to learn whether physicians can associate evidence of myocardial injury after surgery with findings obtained from submaximal cardiopulmonary exercise testing. The main questions are:
Is detection of postoperative myocardial injury with submaximal cardiopulmonary exercise testing superior to using usual care?
Read more
And which submaximal cardiopulmonary exercise testing measure is better?
Participants will undergo evaluation with a short submaximal cardiopulmonary exercise test, then undergo surgery. Myocardial injury will be measured on postoperative days 0, 1, 2, and 3 (during and up to 3 days after surgery). These results will analyzed by comparing it to findings from the submaximal cardiopulmonary exercise test.
If there is a relationship, this will help anesthesiologists and surgeons assign certain treatments that may reduce the risk of developing myocardial injury after surgery.
Read the detailed description
Among the 50 million US adults undergo non-cardiac surgery each year, an estimated 1.4-3.9% of patients experience perioperative myocardial infarction with another 6-18% showing evidence of myocardial injury. These cardiac insults, known as myocardial injury after noncardiac surgery (MINS) are associated with a 2.7-3.2 fold higher odds of 30-day mortality, 2.2 fold higher odds of nonfatal myocardial infarction (MI), 1.55 fold increase in 30-day congestive heart failure events, and 5.2 times higher risk of stroke, highlighting the importance of predicting and treating their occurrence. MINS is treatable, and potentially preventable, by a combination of tailored intraoperative monitoring and appropriate post-operative care.
The current approach to preoperative risk stratification is predominately derived from patient-reported functional capacity associated with history, physical examination and select laboratory investigations. This approach results in significant healthcare worker time and cost expenditures, without improved perioperative outcomes. In contrast, a technological approach utilizing conventional cardiopulmonary exercise testing (CPET) has been shown to improve individualized identification of high-risk patients prior to surgery. Widespread cardiopulmonary exercise test adoption in the perioperative setting, however, has been limited by cost, technical requirements, and time investment despite its documented utility in cardiopulmonary risk assessment. However, brief submaximal cardiopulmonary exercise testing (smCPET) addresses the limitations of conventional CPET including low cost, low time investment, small footprint, and ease of operator efficiency. In our pilot (under review), we demonstrated the feasibility and performance of implementing smCPET within a high-volume pre-surgical evaluation clinic.
This proposal seeks to continue work in characterizing smCPET and its role in individualized preoperative risk identification. The aim of this study proposal is to validate two clinically relevant questions: 1) Are smCPET measures superior to usual care (Duke Activity Status Index) in patients undergoing moderate to high-risk noncardiac surgery and 2) to determine which smCPET measure is more sensitive to MINS as described by abnormalities in postoperative high-sensitivity troponin measurements.
Using a smCPET-guided approach, this study seeks to characterize its value in identifying high-risk patients for MINS, provide further validation of smCPET utility as a preoperative risk stratification approach, and preliminarily identify smCPET measures with highest association with MINS.
If validated, this would provide the foundation for a smCPET-guided clinical decision support system of preoperative identification and perioperative monitoring that could 1) enhance patient outcomes by providing early prediction and detection of MINS and 2) characterize a research methodology to stratify participants for further research in assessing perioperative strategies to reduce MINS. These findings will provide one of the first examples of quantitative and individualized preoperative risk identification methods for a common and deleterious perioperative outcome.
- Conditions
- Myocardial Injury After Non-cardiac Surgery, Submaximal Exercise Performance, Preoperative Period
- Being tested
- High-sensitivity troponin, serum, Submaximal Cardiopulmonary Exercise Testing, Duke Activity Status Index
- Keywords
- submaximal cardiopulmonary exercise testing, MINS, myocardial injury after noncardiac surgery, perioperative myocardial injury, anesthesiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-sensitivity troponin, serumDiagnostic test
Also called HST
A serum derived measure of myocardial injury. Threshold value of 14ng/L.
Submaximal Cardiopulmonary Exercise TestingDiagnostic test
Also called smCPET
FDA-approved device uses breath by breath sampling during calibration and exercise challenge. Analysis is performed using a differential pressure pneumotach method for volume calibration and measurement, an infrared sensor for CO2 and a paramagnetic sensor for O2 measurements. Automated calibration using a calibration gas mixture (15.6% O2/5% CO2) is performed at regular intervals. The Shape II calculations used to differentiate causes of exertional dyspnea are Artificial Intelligence (AI) based algorithms and measurements have been previously validated to conventional cardiopulmonary exercise testing methods. Brief smCPET is comprised of a 2-minute calibration phase, 3 minutes of graded exercise using a stair-step and a 1 minute recovery phase for a total of 6 minutes. An instant report is then generated.
Duke Activity Status IndexDiagnostic test
Also called DASI
A validated measure of preoperative functional capacity which will be utilized to cross-validate smCPET peak VO2. Low DASI score has been found to estimate peak oxygen uptake (VO2), predict MINS, myocardial infarction, and inducible myocardial ischemia on myocardial perfusion scintigraphy.
| Study group | Role | What they receive |
|---|---|---|
| Submaximal cardiopulmonary exercise testing | Experimental | Single arm design; selected participants will receive both usual care (Duke Activity Status Index) and submaximal cardiopulmonary exercise testing. All participants will receive high-sensitivity troponin measurements on operative day 1 and postoperative day 1,2,3 Receives: Diagnostic Test: High-sensitivity troponin, serum; Diagnostic Test: Submaximal Cardiopulmonary Exercise Testing; Diagnostic Test: Duke Activity Status Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
MINS
Myocardial Injury after noncardiac surgery. Measurement: High-Sensitivity Troponin assay with an abnormal value defined as 14 nanograms per liter or greater.
Measured: Operative Day 0, Postoperative Day 1, 2 or 3
Secondary outcomes (3)
30-day Major Adverse Cardiovascular Events
30-day recorded events of atrial fibrillation, angina, stroke, myocardial infarction, congestive heart failure as defined by International Classification of Disease (Version 10) coding.
Measured: Postoperative Day 1 through Postoperative Day 30
Length of Stay
Measurement of patient inpatient status from operative day 0 through physical discharge from the hospital.
Measured: From operative day 0 through hospital discharge up to postoperative day 180
Readmission
Readmission of any type from the time of surgical procedure discharge through postoperative day 60.
Measured: Postoperative Day One through Postoperative Day 60.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start30 Mar 2025
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Why it stopped: Funding limitations.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Myocardial Injury After Non-cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Yale 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-blinded Phase IV diagnostic clinical trial study design
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zyad J Carr, M.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06474754
- Sponsor's protocol ID
- 2000037991
- Acronym
- EnhanceMINS
- Status last verified
- May 2026
- First submitted
- 14 Jun 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The study protocol, statistical analysis plan, informed consent and human study record will be provided. A deidentified dataset will be uploaded to the data sharing repository NIBIB physionet website.
Publications
Snowden CP, Prentis JM, Anderson HL, Roberts DR, Randles D, Renton M, Manas DM. Submaximal cardiopulmonary exercise testing predicts complications and hospital length of stay in patients undergoing major elective surgery. Ann Surg. 2010 Mar;251(3):535-41. doi: 10.1097/SLA.0b013e3181cf811d.
PubMed 20134313Le Manach Y, Perel A, Coriat P, Godet G, Bertrand M, Riou B. Early and delayed myocardial infarction after abdominal aortic surgery. Anesthesiology. 2005 May;102(5):885-91. doi: 10.1097/00000542-200505000-00004.
PubMed 15851872Devereaux PJ, Goldman L, Cook DJ, Gilbert K, Leslie K, Guyatt GH. Perioperative cardiac events in patients undergoing noncardiac surgery: a review of the magnitude of the problem, the pathophysiology of the events and methods to estimate and communicate risk. CMAJ. 2005 Sep 13;173(6):627-34. doi: 10.1503/cmaj.050011.
PubMed 16157727Patel AY, Eagle KA, Vaishnava P. Cardiac risk of noncardiac surgery. J Am Coll Cardiol. 2015 Nov 10;66(19):2140-2148. doi: 10.1016/j.jacc.2015.09.026.
PubMed 26541926
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Precise Perioperative Risk Surveillance: Validation of Submaximal Cardiopulmonary Exercise Testing to Usual Care for Detection of Myocardial Injury After Noncardiac Surgery
- ClinicalTrials.gov ID
- NCT06474754
- Acronym / sponsor ID
- EnhanceMINS / 2000037991
- Conditions
- Myocardial Injury After Non-cardiac Surgery, Submaximal Exercise Performance, Preoperative Period
- Keywords
- submaximal cardiopulmonary exercise testing, MINS, myocardial injury after noncardiac surgery, perioperative myocardial injury, anesthesiology
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding limitations.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 30 Mar 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 26 Jun 2024 (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 goal of this clinical trial is to learn whether physicians can associate evidence of myocardial injury after surgery with findings obtained from submaximal cardiopulmonary exercise testing. The main questions are:
Is detection of postoperative myocardial injury with submaximal cardiopulmonary exercise testing superior to using usual care?
And which submaximal cardiopulmonary exercise testing measure is better?
Participants will undergo evaluation with a short submaximal cardiopulmonary exercise test, then undergo surgery. Myocardial injury will be measured on postoperative days 0, 1, 2, and 3 (during and up to 3 days after surgery). These results will analyzed by comparing it to findings from the submaximal cardiopulmonary exercise test.
If there is a relationship, this will help anesthesiologists and surgeons assign certain treatments that may reduce the risk of developing myocardial injury after surgery.
Detailed description
Among the 50 million US adults undergo non-cardiac surgery each year, an estimated 1.4-3.9% of patients experience perioperative myocardial infarction with another 6-18% showing evidence of myocardial injury. These cardiac insults, known as myocardial injury after noncardiac surgery (MINS) are associated with a 2.7-3.2 fold higher odds of 30-day mortality, 2.2 fold higher odds of nonfatal myocardial infarction (MI), 1.55 fold increase in 30-day congestive heart failure events, and 5.2 times higher risk of stroke, highlighting the importance of predicting and treating their occurrence. MINS is treatable, and potentially preventable, by a combination of tailored intraoperative monitoring and appropriate post-operative care.
The current approach to preoperative risk stratification is predominately derived from patient-reported functional capacity associated with history, physical examination and select laboratory investigations. This approach results in significant healthcare worker time and cost expenditures, without improved perioperative outcomes. In contrast, a technological approach utilizing conventional cardiopulmonary exercise testing (CPET) has been shown to improve individualized identification of high-risk patients prior to surgery. Widespread cardiopulmonary exercise test adoption in the perioperative setting, however, has been limited by cost, technical requirements, and time investment despite its documented utility in cardiopulmonary risk assessment. However, brief submaximal cardiopulmonary exercise testing (smCPET) addresses the limitations of conventional CPET including low cost, low time investment, small footprint, and ease of operator efficiency. In our pilot (under review), we demonstrated the feasibility and performance of implementing smCPET within a high-volume pre-surgical evaluation clinic.
This proposal seeks to continue work in characterizing smCPET and its role in individualized preoperative risk identification. The aim of this study proposal is to validate two clinically relevant questions: 1) Are smCPET measures superior to usual care (Duke Activity Status Index) in patients undergoing moderate to high-risk noncardiac surgery and 2) to determine which smCPET measure is more sensitive to MINS as described by abnormalities in postoperative high-sensitivity troponin measurements.
Using a smCPET-guided approach, this study seeks to characterize its value in identifying high-risk patients for MINS, provide further validation of smCPET utility as a preoperative risk stratification approach, and preliminarily identify smCPET measures with highest association with MINS.
If validated, this would provide the foundation for a smCPET-guided clinical decision support system of preoperative identification and perioperative monitoring that could 1) enhance patient outcomes by providing early prediction and detection of MINS and 2) characterize a research methodology to stratify participants for further research in assessing perioperative strategies to reduce MINS. These findings will provide one of the first examples of quantitative and individualized preoperative risk identification methods for a common and deleterious perioperative outcome.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-blinded Phase IV diagnostic clinical trial study design
| Arm | Type | Receives |
|---|---|---|
| Submaximal cardiopulmonary exercise testing | Experimental | Diagnostic Test: High-sensitivity troponin, serum, Diagnostic Test: Submaximal Cardiopulmonary Exercise Testing, Diagnostic Test: Duke Activity Status IndexSingle arm design; selected participants will receive both usual care (Duke Activity Status Index) and submaximal cardiopulmonary exercise testing. All participants will receive high-sensitivity troponin measurements on operative day 1 and postoperative day 1,2,3 |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Biological male or female, aged 45 years or older.
- In good general health as evidenced by medical history or diagnosed with metabolic equivalents (self-reported ability to climb 1 flight of stairs).
- Revised Cardiac Risk Index less than or equal to three.
Key exclusion criteria (20 listed)
- Inability to perform study procedures as defined by inability to achieve greater than 4 metabolic equivalents (cannot climb 1 flight of stairs reliably).
- Pregnancy or lactation.
- Inability to give independent informed consent.
- Revised cardiac risk index greater than 3.
- Recent myocardial infarction (less than 6 weeks).
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 |
|---|---|---|
| High-sensitivity troponin, serumAlso: HSTA serum derived measure of myocardial injury. Threshold value of 14ng/L. | Diagnostic test | Submaximal cardiopulmonary exercise testing |
| Submaximal Cardiopulmonary Exercise TestingAlso: smCPETFDA-approved device uses breath by breath sampling during calibration and exercise challenge. Analysis is performed using a differential pressure pneumotach method for volume calibration and measurement, an infrared sensor for CO2 and a paramagnetic sensor for O2 measurements. Automated calibration using a calibration gas mixture (15.6% O2/5% CO2) is performed at regular intervals. The Shape II calculations used to differentiate causes of exertional dyspnea are Artificial Intelligence (AI) based algorithms and measurements have been previously validated to conventional cardiopulmonary exercise testing methods. Brief smCPET is comprised of a 2-minute calibration phase, 3 minutes of graded exercise using a stair-step and a 1 minute recovery phase for a total of 6 minutes. An instant report is then generated. | Diagnostic test | Submaximal cardiopulmonary exercise testing |
| Duke Activity Status IndexAlso: DASIA validated measure of preoperative functional capacity which will be utilized to cross-validate smCPET peak VO2. Low DASI score has been found to estimate peak oxygen uptake (VO2), predict MINS, myocardial infarction, and inducible myocardial ischemia on myocardial perfusion scintigraphy. | Diagnostic test | Submaximal cardiopulmonary exercise testing |
Primary outcome
MINS
Time frame: Operative Day 0, Postoperative Day 1, 2 or 3
Myocardial Injury after noncardiac surgery. Measurement: High-Sensitivity Troponin assay with an abnormal value defined as 14 nanograms per liter or greater.
3 secondary outcomes
30-day Major Adverse Cardiovascular Events
Time frame: Postoperative Day 1 through Postoperative Day 30
Length of Stay
Time frame: From operative day 0 through hospital discharge up to postoperative day 180
Readmission
Time frame: Postoperative Day One through Postoperative Day 60.
Results and safety
The study was stopped early (reason given: Funding limitations.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Background: PubMed 20134313Snowden CP, Prentis JM, Anderson HL, Roberts DR, Randles D, Renton M, Manas DM. Submaximal cardiopulmonary exercise testing predicts complications and hospital length of stay in patients undergoing major elective surgery. Ann Surg. 2010 Mar;251(3):535-41. doi: 10.1097/SLA.0b013e3181cf811d.
- Background: PubMed 15851872Le Manach Y, Perel A, Coriat P, Godet G, Bertrand M, Riou B. Early and delayed myocardial infarction after abdominal aortic surgery. Anesthesiology. 2005 May;102(5):885-91. doi: 10.1097/00000542-200505000-00004.
- Background: PubMed 16157727Devereaux PJ, Goldman L, Cook DJ, Gilbert K, Leslie K, Guyatt GH. Perioperative cardiac events in patients undergoing noncardiac surgery: a review of the magnitude of the problem, the pathophysiology of the events and methods to estimate and communicate risk. CMAJ. 2005 Sep 13;173(6):627-34. doi: 10.1503/cmaj.050011.
- Background: PubMed 26541926Patel AY, Eagle KA, Vaishnava P. Cardiac risk of noncardiac surgery. J Am Coll Cardiol. 2015 Nov 10;66(19):2140-2148. doi: 10.1016/j.jacc.2015.09.026.
- Individual participant dataSharing planned: Yes. The study protocol, statistical analysis plan, informed consent and human study record will be provided. A deidentified dataset will be uploaded to the data sharing repository NIBIB physionet website.
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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.
Zyad J Carr, M.D. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-sensitivity troponin, serum, Submaximal Cardiopulmonary Exercise Testing and Duke Activity Status Index in people with Myocardial Injury After Non-cardiac Surgery and Submaximal Exercise Performance, run by Yale 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 20 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 22 May 2026. 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 stopped early (reason given: Funding limitations.). 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?
MINS (time frame: Operative Day 0, Postoperative Day 1, 2 or 3). 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 NCT06474754, which also lists 4 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 22 May 2026.