Ischemic Heart DiseaseEMPIRENCT03217227
Evaluating Myocardial Ischemia in Chest Pain Using Exercise CMR
An observational study of Ischemic Heart Disease and Coronary Artery Disease, run by National Heart Centre Singapore at 2 sites in Singapore.
Trial summary
Ischemic Heart Disease (IHD) is a condition of recurring chest pain or discomfort that occurs when a part of the heart is not receiving sufficient blood flow. It is a major public health concern internationally and in Singapore, the leading cause of death from cardiovascular disease. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Ischemic Heart Disease, Coronary Artery Disease, Cardiovascular Diseases
- What is being tested?
- Cardiovascular Magnetic Resonance Imaging with Exercise Bike, Cardiac Catheterization and Retinal Photography (Optional)
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 2 sitesSingapore
- Study dates
- 1 May 2017to 1 Mar 2025
- 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 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The major source of recruitment for healthy volunteers will be from an existing database of healthy volunteers who have participated in the biobank program and have indicated interest in future studies. Other sources include co-workers of the department who volunteer and indicate on the Informed Consent Document that their participation was entirely voluntary and not coerced. Study Team members are ineligible. The major source of recruitment for patients with stable angina will be from the imaging and admission databases of the National Heart Centre Singapore. Patients are also referred by their attending healthcare professionals. The primary physicians of the patients identified will be notified and recruitment will only proceed if the primary physician is agreeable.
Who may be able to join
- Healthy Volunteers:
- 21 years and above
- Normal physical examination
- No known significant medical history
- Able to give informed consent
- Patients:
Show all 14Show fewer
- 21 years and above
- Stable angina or angina-equivalent
- Has at least one of the following risk factors:
- Smoking
- Diabetes (fasting glucose level > 140 mg/dL)
- Hyperlipidemia (total cholesterol level > 250 mg/dL)
- Abnormal ECG
- Hypertension
Who cannot join
- Healthy Volunteers:
- Contraindications to CMR implantable devices, cerebral aneurysm clips, cochlear implants
- Claustrophobia
- Women who are pregnant
- Inability to comply with study protocol
- Not able to exercise
Show all 17Show fewer
- Patients:
- Unstable cardiac conditions that are deemed by primary investigator to be unsuitable for this study
- Prior coronary revascularization or percutaneous coronary intervention
- Pulmonary disease
- Anemia
- Asthma
- Hyperthermia
- Hyperthyroidism
- Sympathomimetic toxicity
- Polycythemia
- Severely uncontrolled hypertension despite being on at least 3 anti-hypertensive medications
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites, 2 recruiting
- Recruiting
National Heart Centre Singapore
Singapore, 169609
Le Thu Thao, PhD, 6704 2241, le.thu.thao@nhcs.com.sg
Sheryl Lieo, BSc, 6704 2305, sheryl.lieo.w.x@nhcs.com.sg
- Recruiting
National Heart Centre Singapore
Singapore
Thu Thao Le, PhD, 67042241, le.thu.thao@nhcs.com.sg
About this study
Official title: Evaluating Myocardial Ischemia in Chest Pain Using Cardiovascular Magnetic Resonance (CMR) Imaging Exercise Bike
Ischemic Heart Disease (IHD) is a condition of recurring chest pain or discomfort that occurs when a part of the heart is not receiving sufficient blood flow. It is a major public health concern internationally and in Singapore, the leading cause of death from cardiovascular disease. Cardiovascular magnetic resonance (CMR) has the ability to assess heart structures, scarring or lack of blood supply to the heart muscle with great accuracy and without any radiation involved. A CMR-compatible cycle ergometer can offer a safe and low cost stress equipment to assess heart function and motion abnormalities, and restrictions of the blood supply to the heart tissues due to partial or complete blockages of the blood vessels.
This study aims
- to develop an exercise-CMR stress protocol by testing its feasibility and robustness in assessing changes in cardiac volumes and function due to physical exertion in healthy individuals and
- to assess the accuracy of the multiparametric stress-CMR as a diagnostic tool for ischemic-causing coronary artery disease (CAD) with coronary fractional flow reserve (FFR) as a reference.
- to measure the overall economic impact of ischaemic heart disease by estimating the direct and indirect medical costs for each participant. The current sample costs will be extrapolated to estimate the annual costs of treating and managing ischaemic heart disease in the local population.
- to evaluate the effects of coronary microvascular dysfunction on coronary flow and regulation, physiological response and cardiac sympathetic signaling in patients with chest pain.
Read the detailed description
Suspected ischemic heart disease (IHD) or coronary artery disease (CAD) is commonly diagnosed by stress testing where patients undergo exercise tests in order to make their hearts work hard and beat fast to require more blood and oxygen. Pharmacological-induced stress is employed in the case where the patient is unable to exercise. Since plaque-narrowed arteries cannot supply enough oxygen-rich blood to meet the heart's needs, the stress test can show signs and symptoms of IHD. Some of the symptoms include abnormal changes in the heart rate or blood pressure, shortness of breath, chest pain, or abnormal changes in the heart's rhythm and electrical activity.
As part of the stress tests, images of the heart are taken while the patient is exercising and while the patient is at rest. The imaging stress tests will show how well the blood flows in and out of the heart. An example would be a stress echocardiogram where an ultrasound is performed on the chest to produce video images of the heart to. IHD is detected through development of new regional wall motion abnormalities or worsening of preexisting regional wall motions. The patient will be required to exercise on a treadmill before lying on the examination bed for the ultrasound scan. This however, would require the patient to move from the treadmill to the bed, which would result in some time delay.
Another diagnostic test commonly used to diagnose IHD would be a nuclear scan known as myocardial perfusion imaging where a radioactive isotope acting as a tracer is injected into the bloodstream. During exercise, the tracer is monitored while it flows through the heart and lungs to allow detection for any blood-flow problems. However, this test would involve ionizing radiation due to the radioactive isotopic tracer used.
A detailed test to view blood flow through the heart, would be through a cardiac catheterization or an angiogram where a thin and flexible tube known as a catheter is threaded through an artery, usually in the leg, to the heart arteries. An invisible dye is injected through the catheter and special x-rays will be taken while the dye flows through the coronary arteries, allowing the doctor to study the blood flow through the heart and blood vessels. Due to the nature of the catheterization with the insertion of the tube, it makes the procedure invasive and hence involving risks although they are rare.
Cardiovascular magnetic resonance (CMR) is able to accurately and non-radiatively assess the heart structure, any scarring or lack of blood supply to the heart muscle. A CMR-compatible cycle ergometer offers a one-stop diagnostic test that is non-radiative and non-invasive. Hence, our investigators aim to develop a protocol that does not require any invasive procedure by assessing its accuracy and develop reference ranges in healthy individuals.
- Conditions
- Ischemic Heart Disease, Coronary Artery Disease, Cardiovascular Diseases, Myocardial Ischemia, Coronary Heart Disease, Microvascular Coronary Artery Disease
- Being tested
- Cardiovascular Magnetic Resonance Imaging with Exercise Bike, Cardiac Catheterization, Retinal Photography (Optional), I123 MIBG Scintigraphy (Optional)
- Medical subject headings
- Myocardial Ischemia, Coronary Artery Disease, Cardiovascular Diseases, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular Magnetic Resonance Imaging with Exercise BikeOther
Also called Bike MRI, CMR stress protocol
A rest scan is performed and a gadolinium contrast may be administered during the scan (depending on the kidney function). After the rest scan is completed, images of the subject's heart during exercise via cycling in the supine position, will be scanned.
Cardiac CatheterizationProcedure or surgery
Also called Coronary Angiogram, Fractional Flow Resistance Measurement (FFR), Index of Microvascular Resistance Measurement (IMR), Coronary Pressure Measurement
It is a procedure to diagnose and treat cardiovascular diseases by inserting a long and thin tube known as a catheter into the artery or vein in the neck, groin or arm and threaded through the blood vessels to the heart.
A coronary angiogram is also performed during the procedure where an invisible contrast dye (only visible in the X-rays) is injected through the catheter and X-ray images scanned will show the flow of the dye through the heart arteries to determine any blockages in the arteries.
In the case where there is severe narrowings, fractional flow reserve (FFR) may be performed to measure the pressure in the coronary arteries.
If there is no significant narrowing lesions, the interventionist may perform additional flow resistance measurements of the small vessels to further investigate the cause of angina
Retinal Photography (Optional)Other
The test studies the structure and function of the eye vessels. It involves using eye drops to dilate the pupils, allowing the retinal photographer to have a better view of the back of the eye.
I123 MIBG Scintigraphy (Optional)Diagnostic test
Also called Iodine-123-metaiodobenzylguanidine scintigraphy
The test studies the cardiac sympathetic signalling that may help to identify patients with high risks of adverse events. The scan consists of 2 acquisitions of images 3-4 hours apart.
For this study, only patients without clinically significant lesions (diagnosed via the cardiac catetherisation and have normal FFR results) will undergo this test.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteer | Healthy Volunteers will undergo the following study procedures:
1. Cardiovascular Magnetic Resonance Imaging with Exercise Bike
2. Blood Sampling
3. Activity and Lifestyle Questionnaires
4. Fat Mass Measurement Receives: Other: Cardiovascular Magnetic Resonance Imaging with Exercise Bike | |
| Patients with Stable Angina | Patients will undergo the following study procedures:
1. Cardiovascular Magnetic Resonance Imaging with Exercise Bike
2. Blood Sampling
3. Cardiac Catheterization
4. Activity, Lifestyle and Medication Compliance Questionnaires
5. Fat Mass Measurement
6. Retinal Photography (Optional)
7. I123 MIBG scan (Optional) Receives: Other: Cardiovascular Magnetic Resonance Imaging with Exercise Bike; Procedure: Cardiac Catheterization; Other: Retinal Photography (Optional); Diagnostic Test: I123 MIBG Scintigraphy (Optional) |
What is being measured
The primary outcome is the main question the study is designed to answer.
First occurrence of cardiovascular event
The outcomes are obtained via hospital records or phone follow-ups
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start1 May 2017
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart DiseaseStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Heart Centre Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Le Thu Thao, PhD, Principal investigator, National Heart Research Institute Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03217227
- Sponsor's protocol ID
- 2017/2123
- Acronym
- EMPIRE
- Status last verified
- Apr 2023
- First submitted
- 11 Jul 2017
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Le TT, Ang BWY, Bryant JA, Chin CY, Yeo KK, Wong PEH, Ho KW, Tan JWC, Lee PT, Chin CWL, Cook SA. Multiparametric exercise stress cardiovascular magnetic resonance in the diagnosis of coronary artery disease: the EMPIRE trial. J Cardiovasc Magn Reson. 2021 Mar 4;23(1):17. doi: 10.1186/s12968-021-00705-8.
PubMed 33658056
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Myocardial Ischemia in Chest Pain Using Cardiovascular Magnetic Resonance (CMR) Imaging Exercise Bike
- ClinicalTrials.gov ID
- NCT03217227
- Acronym / sponsor ID
- EMPIRE / 2017/2123
- Conditions
- Ischemic Heart Disease, Coronary Artery Disease, Cardiovascular Diseases, Myocardial Ischemia, Coronary Heart Disease, Microvascular Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Heart Centre SingaporeUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 14 Jul 2017 (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.
Ischemic Heart Disease (IHD) is a condition of recurring chest pain or discomfort that occurs when a part of the heart is not receiving sufficient blood flow. It is a major public health concern internationally and in Singapore, the leading cause of death from cardiovascular disease. Cardiovascular magnetic resonance (CMR) has the ability to assess heart structures, scarring or lack of blood supply to the heart muscle with great accuracy and without any radiation involved. A CMR-compatible cycle ergometer can offer a safe and low cost stress equipment to assess heart function and motion abnormalities, and restrictions of the blood supply to the heart tissues due to partial or complete blockages of the blood vessels.
This study aims
- to develop an exercise-CMR stress protocol by testing its feasibility and robustness in assessing changes in cardiac volumes and function due to physical exertion in healthy individuals and
- to assess the accuracy of the multiparametric stress-CMR as a diagnostic tool for ischemic-causing coronary artery disease (CAD) with coronary fractional flow reserve (FFR) as a reference.
- to measure the overall economic impact of ischaemic heart disease by estimating the direct and indirect medical costs for each participant. The current sample costs will be extrapolated to estimate the annual costs of treating and managing ischaemic heart disease in the local population.
- to evaluate the effects of coronary microvascular dysfunction on coronary flow and regulation, physiological response and cardiac sympathetic signaling in patients with chest pain.
Detailed description
Suspected ischemic heart disease (IHD) or coronary artery disease (CAD) is commonly diagnosed by stress testing where patients undergo exercise tests in order to make their hearts work hard and beat fast to require more blood and oxygen. Pharmacological-induced stress is employed in the case where the patient is unable to exercise. Since plaque-narrowed arteries cannot supply enough oxygen-rich blood to meet the heart's needs, the stress test can show signs and symptoms of IHD. Some of the symptoms include abnormal changes in the heart rate or blood pressure, shortness of breath, chest pain, or abnormal changes in the heart's rhythm and electrical activity.
As part of the stress tests, images of the heart are taken while the patient is exercising and while the patient is at rest. The imaging stress tests will show how well the blood flows in and out of the heart. An example would be a stress echocardiogram where an ultrasound is performed on the chest to produce video images of the heart to. IHD is detected through development of new regional wall motion abnormalities or worsening of preexisting regional wall motions. The patient will be required to exercise on a treadmill before lying on the examination bed for the ultrasound scan. This however, would require the patient to move from the treadmill to the bed, which would result in some time delay.
Another diagnostic test commonly used to diagnose IHD would be a nuclear scan known as myocardial perfusion imaging where a radioactive isotope acting as a tracer is injected into the bloodstream. During exercise, the tracer is monitored while it flows through the heart and lungs to allow detection for any blood-flow problems. However, this test would involve ionizing radiation due to the radioactive isotopic tracer used.
A detailed test to view blood flow through the heart, would be through a cardiac catheterization or an angiogram where a thin and flexible tube known as a catheter is threaded through an artery, usually in the leg, to the heart arteries. An invisible dye is injected through the catheter and special x-rays will be taken while the dye flows through the coronary arteries, allowing the doctor to study the blood flow through the heart and blood vessels. Due to the nature of the catheterization with the insertion of the tube, it makes the procedure invasive and hence involving risks although they are rare.
Cardiovascular magnetic resonance (CMR) is able to accurately and non-radiatively assess the heart structure, any scarring or lack of blood supply to the heart muscle. A CMR-compatible cycle ergometer offers a one-stop diagnostic test that is non-radiative and non-invasive. Hence, our investigators aim to develop a protocol that does not require any invasive procedure by assessing its accuracy and develop reference ranges in healthy individuals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteer | – | Other: Cardiovascular Magnetic Resonance Imaging with Exercise BikeHealthy Volunteers will undergo the following study procedures: 1. Cardiovascular Magnetic Resonance Imaging with Exercise Bike 2. Blood Sampling 3. Activity and Lifestyle Questionnaires 4. Fat Mass Measurement |
| Patients with Stable Angina | – | Other: Cardiovascular Magnetic Resonance Imaging with Exercise Bike, Procedure: Cardiac Catheterization, Other: Retinal Photography (Optional), Diagnostic Test: I123 MIBG Scintigraphy (Optional)Patients will undergo the following study procedures: 1. Cardiovascular Magnetic Resonance Imaging with Exercise Bike 2. Blood Sampling 3. Cardiac Catheterization 4. Activity, Lifestyle and Medication Compliance Questionnaires 5. Fat Mass Measurement 6. Retinal Photography (Optional) 7. I123 MIBG scan (Optional) |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The major source of recruitment for healthy volunteers will be from an existing database of healthy volunteers who have participated in the biobank program and have indicated interest in future studies. Other sources include co-workers of the department who volunteer and indicate on the Informed Consent Document that their participation was entirely voluntary and not coerced. Study Team members are ineligible. The major source of recruitment for patients with stable angina will be from the imaging and admission databases of the National Heart Centre Singapore. Patients are also referred by their attending healthcare professionals. The primary physicians of the patients identified will be notified and recruitment will only proceed if the primary physician is agreeable.
Key inclusion criteria (14 listed)
- 21 years and above
- Normal physical examination
- No known significant medical history
- Able to give informed consent
- 21 years and above
Key exclusion criteria (17 listed)
- Contraindications to CMR implantable devices, cerebral aneurysm clips, cochlear implants
- Claustrophobia
- Women who are pregnant
- Inability to comply with study protocol
- Not able to exercise
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 |
|---|---|---|
| Cardiovascular Magnetic Resonance Imaging with Exercise BikeAlso: Bike MRI, CMR stress protocolA rest scan is performed and a gadolinium contrast may be administered during the scan (depending on the kidney function). After the rest scan is completed, images of the subject's heart during exercise via cycling in the supine position, will be scanned. | Other | Healthy Volunteer, Patients with Stable Angina |
| Cardiac CatheterizationAlso: Coronary Angiogram, Fractional Flow Resistance Measurement (FFR), Index of Microvascular Resistance Measurement (IMR), Coronary Pressure MeasurementIt is a procedure to diagnose and treat cardiovascular diseases by inserting a long and thin tube known as a catheter into the artery or vein in the neck, groin or arm and threaded through the blood vessels to the heart. A coronary angiogram is also performed during the procedure where an invisible contrast dye (only visible in the X-rays) is injected through the catheter and X-ray images scanned will show the flow of the dye through the heart arteries to determine any blockages in the arteries. In the case where there is severe narrowings, fractional flow reserve (FFR) may be performed to measure the pressure in the coronary arteries. If there is no significant narrowing lesions, the interventionist may perform additional flow resistance measurements of the small vessels to further investigate the cause of angina | Procedure or surgery | Patients with Stable Angina |
| Retinal Photography (Optional)The test studies the structure and function of the eye vessels. It involves using eye drops to dilate the pupils, allowing the retinal photographer to have a better view of the back of the eye. | Other | Patients with Stable Angina |
| I123 MIBG Scintigraphy (Optional)Also: Iodine-123-metaiodobenzylguanidine scintigraphyThe test studies the cardiac sympathetic signalling that may help to identify patients with high risks of adverse events. The scan consists of 2 acquisitions of images 3-4 hours apart. For this study, only patients without clinically significant lesions (diagnosed via the cardiac catetherisation and have normal FFR results) will undergo this test. | Diagnostic test | Patients with Stable Angina |
Primary outcome
First occurrence of cardiovascular event
Time frame: One year
The outcomes are obtained via hospital records or phone follow-ups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Derived from this study: PubMed 33658056Le TT, Ang BWY, Bryant JA, Chin CY, Yeo KK, Wong PEH, Ho KW, Tan JWC, Lee PT, Chin CWL, Cook SA. Multiparametric exercise stress cardiovascular magnetic resonance in the diagnosis of coronary artery disease: the EMPIRE trial. J Cardiovasc Magn Reson. 2021 Mar 4;23(1):17. doi: 10.1186/s12968-021-00705-8.
- Individual participant dataSharing planned: No
Related trials for Ischemic Heart Disease
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Active, not recruitingPhase 4
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Coronary Artery Disease
RecruitingPhase 4
CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes Patients With Stage 4 CKM Syndrome
ACS (Acute Coronary Syndrome), SGLT2 Inhibitors
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
RecruitingObservational study
Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors
Testicular Cancer, Survivorship
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.
Le Thu Thao, PhD principal investigator
National Heart Research Institute Singapore
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 Ischemic Heart Disease and Coronary Artery Disease, run by National Heart Centre Singapore at 2 sites in Singapore.
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 14 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 12 Apr 2023. 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 Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thu Thao Le, PhD (67042241, le.thu.thao@nhcs.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First occurrence of cardiovascular event (time frame: One year). 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 NCT03217227, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.