ANOCACoroPhys-CZNCT07103317
Comprehensive Coronary Physiology in Patients With Angina With Nonobstructive Coronary Arteries - Czech Republic
An observational study of ANOCA and ANOCA - Angina With Non-obstructive Coronary Arteries, run by University Hospital, Motol at 1 site in Czechia.
Trial summary
Coronary artery disease (CAD) is a leading cause of morbidity and mortality. While cardiologists have been focused on discrete, visible stenoses of coronary arteries, there is increasing awareness of the importance of microcirculation and vasospastic disorders in causing angina. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ANOCA, ANOCA - Angina With Non-obstructive Coronary Arteries, MINOCA
- How many people
- 1,000 participants
- Where
- 1 siteCzechia
- Study dates
- 20 Apr 2023to 1 Jan 2030
- How long will I take part?
- 100 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The prospective and observational study will include patients who underwent microcirculation assessment or vasospastic testing using intracoronary Ach (or both as parts of CFT). As described above, participants will undergo routine coronary angiography and comprehensive physiologic testing by coronary thermodilution to evaluate CMD and provocative Ach testing for diagnosing vasospastic angina (VSA).
Who may be able to join
- Adults of both sexes older than 18 years
- Angina symptoms or angina equivalent
- Referred to cath lab for evaluation of CAD
- Invasive physiology testing performed (microcirculation testing +/- vasospasm testing)
Who cannot join
- Persons under the age of 18
- Pregnant of nursing
- No coronary physiology measurements were performed
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Motol
Prague, Česká Republika, 15006
Petr Kala, M.D., Ph.D., +420702024181, petr.kala@fnmotol.cz
Petr Kala, M.D., Ph.D.
About this study
Official title: Comprehensive COROnary PHYSiology Assessment in Patients With Angina With Nonobstructive Coronary Arteries - CZECH Republic (CoroPhys-CZECH)
Coronary artery disease (CAD) is a leading cause of morbidity and mortality. While cardiologists have been focused on discrete, visible stenoses of coronary arteries, there is increasing awareness of the importance of microcirculation and vasospastic disorders in causing angina. The microvascular bed is composed of vessels smaller than 400 microns in diameter. Their network is significantly larger than that of the epicardial vessels and serves essential functions, including regulating myocardial blood flow and cellular metabolism.
Angina pectoris, a most frequent symptom of CAD or myocardial ischemia, was assumed to be caused by significant stenosis of the epicardial coronary artery. However, it was found that in over 50% of cases, there was no obstructive CAD, which is described as angina with no obstructive coronary arteries (ANOCA) or ischemia with no obstructive coronary arteries (INOCA), according to the clinical setting.
Read the detailed description
Two mechanisms are primarily involved in the pathophysiology: structural and functional impairment, which can affect both epicardial and microcirculatory arteries and may also be combined. Thus, from a clinical point of view, two basic endotypes are distinguished in ANOCA: 1) microvascular angina (MVA) due to structural damage of microcirculation (coronary microvascular dysfunction - CMD), or functional microvascular vasospasm (angina and ECG changes without epicardial vasospasm on acetylcholine testing) and 2) epicardial vasospastic angina (VSA) - angina, ECG changes and vasospasm on acetylcholine testing (Table 1).
- Microvascular Angina (MVA) (FFR > 0,80, iFR > 0,89)
- coronary microvascular dysfunction (CMD) (CFR < 2,0 (2,5), MRR < 2,1, IMR > 25)
- microvascular vasospasm (angina + ECG changes + < 90% epicardial spasm during Ach testing)
- Vasospastic Angina (VSA) (angina + ECG changes + > 90% epicardial spasm during Ach testing)
- Non-coronary chest pain (negative thermodilution and Ach testing)
Table 1 - ANOCA endotypes. FFR - fractional flow reserve, iFR - instantaneous wave-free ratio, CFR - coronary flow reserve, MRR - microvascular resistance reserve, IMR - index of microcirculatory resistance, EKG - electrocardiogram, Ach - acetylcholine.
The clinical manifestation of ANOCA includes a wide range of symptoms that reduce the quality of life and are often misdiagnosed, mistreated, and not infrequently, leading to repeated hospitalizations and invasive investigations. At the same time, patients with both MVA and VSA have a poorer long-term prognosis. Direct assessment of the response of the coronary microcirculation to vasodilator stimuli and diagnosis of vasomotor abnormalities are crucial for accurate stratification and selection of treatment strategies for patients with ANOCA, resulting in reduced angina severity and improved quality of life compared to standard care. Comprehensive invasive coronary functional testing (CFT) is currently the only diagnostic method to establish a definitive diagnosis and characterize a specific ANOCA endotype, supported by professional societies' current recommendations.
CFT consists of a complete invasive assessment of epicardial and microcirculatory structural and functional disorders. It starts with coronary angiography (CA) to exclude structural epicardial CAD accompanied by testing of the hemodynamic significance of epicardial stenoses by a hyperemic or non-hyperemic index (i.e., fractional flow reserve (FFR) or instantaneous wave-free ratio (iFR)) if necessary. When there is no significant epicardial CAD, the protocol continues with coronary thermodilution to investigate microcirculatory function by measuring intracoronary blood flow and resistances by temperature-pressure intracoronary wire (PressureWire X, Abbott) during rest and hyperemia caused by saline solution infused by a dedicated microcatheter (RayFlow, HexaCath). Coroventis software calculates the coronary flow reserve (CFR) and microvascular resistance reserve (MRR) or index of microcirculatory resistance (IMR) when using bolus thermodilution. CMD occurs when CFR and MRR are reduced, or IMR is increased (Table 2). The last part of the CFT aims to test coronary vasoreactivity to an intracoronary bolus of Acetylcholine (Ach), which should cause vasodilatation in physiological circumstances; however, it may lead to vasoconstriction and vasospasm if endothelial dysfunction or imbalance between vasodilatation and vasoconstriction vascular pathways. The Ach test is positive for VSA when Ach induces symptoms typical for the patient (the reason for the invasive examination), ischemic EKG changes, and proven epicardial spasm by angiography after Ach bolus. When there are only typical symptoms and ischemic EKG changes, but without visible epicardial spasms on angiography, it is concluded as microvascular vasospasm (a sub-endotype of MVA). When all three parts of CFT are negative (CA for epicardial structural CAD, thermodilution for microvascular structural CAD, and Ach testing for vasospasm), the symptoms are suggested to be non-coronary or non-cardiac.
Abbreviation Parameter Methodology Pathology Calculation
- CFR coronary flow reserve intracoronary Doppler, thermodilution < 2,0-2,5 Doppler: APVhyper/APVrest bolus thermodilution: Tmn,rest/Tmn,hyper cont. thermodilution: Qhyper/Qrest
- IMR index of microcirculatory resistance bolus thermodilution > 25 Pd x Tmn during hyperemia
- MRR microvascular resistance reserve continuous thermodilution < 2,1 (CFR/FFR) x (Pa,rest/ Pa,hyper) (Qhyper/Qrest) x (Pa,rest / Pd,hyper)
- Rmikro absolute resistance continuous thermodilution > 500 WU Pd/Q
Table 2 - Microcirculatory indexes. CFR - coronary flow reserve, MRR - microvascular resistance reserve, IMR - index of microcirculatory resistance, Rmikro - absolute resistance, APV - average peak velocity, Tmn - mean transit time, Q - flow, Pd - distal pressure, FFR - fractional flow reserve, Pa - aortic pressure, WU - Wood Units.
Given all the evidence outlined above, a hypothesis has been formulated:
Specific ANOCA endotypes differ in prevalence, clinical presentation, and therapeutic management. A tailored approach based on leading pathophysiology would improve symptoms and quality of life. EAT plays an important role in the development and pathophysiology of CMD and vasospastic disorders.
The aim is to evaluate the practice of patient selection for the assessment of ANOCA endotypes, including indications, ischemia tests performed, medications prescribed, procedural aspects of microcirculation, and changes in evaluation and treatment following testing. Additionally, investigators seek insight into adverse cardiovascular events in these patients following invasive coronary physiology. Furthermore, the aim is to investigate the pathophysiology of microvascular dysfunction and coronary vasospastic disorders, specifically the relationship between EAT measured by CMR and CMD measured by invasive hemodynamic techniques.
Within this aim, the following specific goals will be addressed:
Aim 1: To assess the practice of patient selection for assessment of invasive coronary physiology, including vasospasm testing and estimation of microcirculation by measuring CFR and IMR or MRR.
Aim 2: To assess procedural aspects of invasive coronary physiology - how parameters mentioned above are measured in the catheterization laboratory.
Aim 3: To assess patients' treatment and changes after invasive coronary physiology measurements at each follow-up visit.
Aim 4: To compare the cardiovascular outcomes and additional procedures (stress testing, angiography, etc.) done after comprehensive invasive coronary physiology evaluation.
Aim 5: To correlate the volume of EAT measured by CMR with results of CFT, especially CFR, MRR, IMR, and vasospasms.
To address these specific goals, the investigators plan to employ the following experimental models and the following drugs.
- Conditions
- ANOCA, ANOCA - Angina With Non-obstructive Coronary Arteries, MINOCA, Microvascular Dysfunction, Microvascular Angina, Vasospastic Angina
- Keywords
- ANOCA, INOCA, MINOCA, Coronary Microvascular Dysfunction, Microvascular Angina, Vasospastic Angina, Acetylcholine Testing, Coronary Termodilution
- Medical subject headings
- MINOCA, Microvascular Angina, Angina Pectoris, Variant
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause death
All-cause death
Measured: 1 year
Components of MACE
Cardiovascular death, MI, coronary revascularisation, stroke, hospitalization for heart failure, hospitalization for acute coronary syndrome, repeated coronary angiography
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start20 Apr 2023
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ANOCAStudies 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
- 1,000 participants (estimated)
- Target duration
- 100 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Motol
- Sponsor type
- University, hospital or other
- Collaborators
- St. Anne's University Hospital Brno, Czech Republic, Nemocnice AGEL Trinec-Podlesi a.s., Brno University Hospital, Institute for Clinical and Experimental Medicine
- Responsible party
- Principal investigator, Petr Kala, MD, University Hospital, Motol
- Investigators
- Petr Kala, M.D., Ph.D., Principal investigator, University Hospital Motol, Charles University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07103317
- Sponsor's protocol ID
- EK -151.42/25
- Acronym
- CoroPhys-CZ
- Status last verified
- Aug 2025
- First submitted
- 16 Jul 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive COROnary PHYSiology Assessment in Patients With Angina With Nonobstructive Coronary Arteries - CZECH Republic (CoroPhys-CZECH)
- ClinicalTrials.gov ID
- NCT07103317
- Acronym / sponsor ID
- CoroPhys-CZ / EK -151.42/25
- Conditions
- ANOCA, ANOCA - Angina With Non-obstructive Coronary Arteries, MINOCA, Microvascular Dysfunction, Microvascular Angina, Vasospastic Angina
- Keywords
- ANOCA, INOCA, MINOCA, Coronary Microvascular Dysfunction, Microvascular Angina, Vasospastic Angina, Acetylcholine Testing, Coronary Termodilution
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, MotolUniversity, hospital or other
- Collaborators
- St. Anne's University Hospital Brno, Czech Republic, Nemocnice AGEL Trinec-Podlesi a.s., Brno University Hospital, Institute for Clinical and Experimental Medicine
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 5 Aug 2025 (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.
Coronary artery disease (CAD) is a leading cause of morbidity and mortality. While cardiologists have been focused on discrete, visible stenoses of coronary arteries, there is increasing awareness of the importance of microcirculation and vasospastic disorders in causing angina. The microvascular bed is composed of vessels smaller than 400 microns in diameter. Their network is significantly larger than that of the epicardial vessels and serves essential functions, including regulating myocardial blood flow and cellular metabolism.
Angina pectoris, a most frequent symptom of CAD or myocardial ischemia, was assumed to be caused by significant stenosis of the epicardial coronary artery. However, it was found that in over 50% of cases, there was no obstructive CAD, which is described as angina with no obstructive coronary arteries (ANOCA) or ischemia with no obstructive coronary arteries (INOCA), according to the clinical setting.
Detailed description
Two mechanisms are primarily involved in the pathophysiology: structural and functional impairment, which can affect both epicardial and microcirculatory arteries and may also be combined. Thus, from a clinical point of view, two basic endotypes are distinguished in ANOCA: 1) microvascular angina (MVA) due to structural damage of microcirculation (coronary microvascular dysfunction - CMD), or functional microvascular vasospasm (angina and ECG changes without epicardial vasospasm on acetylcholine testing) and 2) epicardial vasospastic angina (VSA) - angina, ECG changes and vasospasm on acetylcholine testing (Table 1).
- Microvascular Angina (MVA) (FFR > 0,80, iFR > 0,89)
- coronary microvascular dysfunction (CMD) (CFR < 2,0 (2,5), MRR < 2,1, IMR > 25)
- microvascular vasospasm (angina + ECG changes + < 90% epicardial spasm during Ach testing)
- Vasospastic Angina (VSA) (angina + ECG changes + > 90% epicardial spasm during Ach testing)
- Non-coronary chest pain (negative thermodilution and Ach testing)
Table 1 - ANOCA endotypes. FFR - fractional flow reserve, iFR - instantaneous wave-free ratio, CFR - coronary flow reserve, MRR - microvascular resistance reserve, IMR - index of microcirculatory resistance, EKG - electrocardiogram, Ach - acetylcholine.
The clinical manifestation of ANOCA includes a wide range of symptoms that reduce the quality of life and are often misdiagnosed, mistreated, and not infrequently, leading to repeated hospitalizations and invasive investigations. At the same time, patients with both MVA and VSA have a poorer long-term prognosis. Direct assessment of the response of the coronary microcirculation to vasodilator stimuli and diagnosis of vasomotor abnormalities are crucial for accurate stratification and selection of treatment strategies for patients with ANOCA, resulting in reduced angina severity and improved quality of life compared to standard care. Comprehensive invasive coronary functional testing (CFT) is currently the only diagnostic method to establish a definitive diagnosis and characterize a specific ANOCA endotype, supported by professional societies' current recommendations.
CFT consists of a complete invasive assessment of epicardial and microcirculatory structural and functional disorders. It starts with coronary angiography (CA) to exclude structural epicardial CAD accompanied by testing of the hemodynamic significance of epicardial stenoses by a hyperemic or non-hyperemic index (i.e., fractional flow reserve (FFR) or instantaneous wave-free ratio (iFR)) if necessary. When there is no significant epicardial CAD, the protocol continues with coronary thermodilution to investigate microcirculatory function by measuring intracoronary blood flow and resistances by temperature-pressure intracoronary wire (PressureWire X, Abbott) during rest and hyperemia caused by saline solution infused by a dedicated microcatheter (RayFlow, HexaCath). Coroventis software calculates the coronary flow reserve (CFR) and microvascular resistance reserve (MRR) or index of microcirculatory resistance (IMR) when using bolus thermodilution. CMD occurs when CFR and MRR are reduced, or IMR is increased (Table 2). The last part of the CFT aims to test coronary vasoreactivity to an intracoronary bolus of Acetylcholine (Ach), which should cause vasodilatation in physiological circumstances; however, it may lead to vasoconstriction and vasospasm if endothelial dysfunction or imbalance between vasodilatation and vasoconstriction vascular pathways. The Ach test is positive for VSA when Ach induces symptoms typical for the patient (the reason for the invasive examination), ischemic EKG changes, and proven epicardial spasm by angiography after Ach bolus. When there are only typical symptoms and ischemic EKG changes, but without visible epicardial spasms on angiography, it is concluded as microvascular vasospasm (a sub-endotype of MVA). When all three parts of CFT are negative (CA for epicardial structural CAD, thermodilution for microvascular structural CAD, and Ach testing for vasospasm), the symptoms are suggested to be non-coronary or non-cardiac.
Abbreviation Parameter Methodology Pathology Calculation
- CFR coronary flow reserve intracoronary Doppler, thermodilution < 2,0-2,5 Doppler: APVhyper/APVrest bolus thermodilution: Tmn,rest/Tmn,hyper cont. thermodilution: Qhyper/Qrest
- IMR index of microcirculatory resistance bolus thermodilution > 25 Pd x Tmn during hyperemia
- MRR microvascular resistance reserve continuous thermodilution < 2,1 (CFR/FFR) x (Pa,rest/ Pa,hyper) (Qhyper/Qrest) x (Pa,rest / Pd,hyper)
- Rmikro absolute resistance continuous thermodilution > 500 WU Pd/Q
Table 2 - Microcirculatory indexes. CFR - coronary flow reserve, MRR - microvascular resistance reserve, IMR - index of microcirculatory resistance, Rmikro - absolute resistance, APV - average peak velocity, Tmn - mean transit time, Q - flow, Pd - distal pressure, FFR - fractional flow reserve, Pa - aortic pressure, WU - Wood Units.
Given all the evidence outlined above, a hypothesis has been formulated:
Specific ANOCA endotypes differ in prevalence, clinical presentation, and therapeutic management. A tailored approach based on leading pathophysiology would improve symptoms and quality of life. EAT plays an important role in the development and pathophysiology of CMD and vasospastic disorders.
The aim is to evaluate the practice of patient selection for the assessment of ANOCA endotypes, including indications, ischemia tests performed, medications prescribed, procedural aspects of microcirculation, and changes in evaluation and treatment following testing. Additionally, investigators seek insight into adverse cardiovascular events in these patients following invasive coronary physiology. Furthermore, the aim is to investigate the pathophysiology of microvascular dysfunction and coronary vasospastic disorders, specifically the relationship between EAT measured by CMR and CMD measured by invasive hemodynamic techniques.
Within this aim, the following specific goals will be addressed:
Aim 1: To assess the practice of patient selection for assessment of invasive coronary physiology, including vasospasm testing and estimation of microcirculation by measuring CFR and IMR or MRR.
Aim 2: To assess procedural aspects of invasive coronary physiology - how parameters mentioned above are measured in the catheterization laboratory.
Aim 3: To assess patients' treatment and changes after invasive coronary physiology measurements at each follow-up visit.
Aim 4: To compare the cardiovascular outcomes and additional procedures (stress testing, angiography, etc.) done after comprehensive invasive coronary physiology evaluation.
Aim 5: To correlate the volume of EAT measured by CMR with results of CFT, especially CFR, MRR, IMR, and vasospasms.
To address these specific goals, the investigators plan to employ the following experimental models and the following drugs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 100 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The prospective and observational study will include patients who underwent microcirculation assessment or vasospastic testing using intracoronary Ach (or both as parts of CFT). As described above, participants will undergo routine coronary angiography and comprehensive physiologic testing by coronary thermodilution to evaluate CMD and provocative Ach testing for diagnosing vasospastic angina (VSA).
Key inclusion criteria (4 listed)
- Adults of both sexes older than 18 years
- Angina symptoms or angina equivalent
- Referred to cath lab for evaluation of CAD
- Invasive physiology testing performed (microcirculation testing +/- vasospasm testing)
Key exclusion criteria (3 listed)
- Persons under the age of 18
- Pregnant of nursing
- No coronary physiology measurements were performed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause death
Time frame: 1 year
All-cause death
Components of MACE
Time frame: 1 year
Cardiovascular death, MI, coronary revascularisation, stroke, hospitalization for heart failure, hospitalization for acute coronary syndrome, repeated coronary angiography
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for ANOCA
Recruiting
Invasive Evaluation and Phenotype-Guided Treatment of ANOCA in Women
ANOCA - Angina With Non-obstructive Coronary Arteries, Coronary Microvascular Dysfunction (CMD)
Active, not recruiting
Coronary Sinus Reducer Implantation in Patients With Ischaemia and Non-obstructed Coronary Arteries and Coronary Microvascular Dysfunction.
Refractory Angina, Microvascular Angina
Recruiting
Analysis of Coronary Reactivity Testing With and Without Intracoronary Nitrate Testing
ANOCA - Angina With Non-obstructive Coronary Arteries, INOCA (Ischemia With Non Obstructive Coronary Artery Disease)
Not yet recruiting
Non-invasive Evaluation of Patients With Angina and Non-obstructive Coronary Artery Disease
ANOCA - Angina With Non-obstructive Coronary Arteries
Recruiting
Coronary Sinus Reducer in Patients With Angina With no Obstructive Coronary Disease
Angina With No Obstructive Coronary Artery Disease, ANOCA
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.
Petr Kala, M.D., Ph.D. principal investigator
University Hospital Motol, Charles 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 ANOCA and ANOCA - Angina With Non-obstructive Coronary Arteries, run by University Hospital, Motol at 1 site in Czechia.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Petr Kala, M.D., Ph.D. (+420702024181, petr.kala@fnmotol.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause death (time frame: 1 year). 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?
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 5 Aug 2025; AzTrials last refreshed its copy on 7 Nov 2026.