Coronary Artery DiseaseNCT06947564
AccuIMR Predicts Microvascular Obstruction and Infarct Size in STEMI Patients
An observational study of Coronary Artery Disease and STEMI - ST Elevation Myocardial Infarction, run by RenJi Hospital at 1 site in China.
Trial summary
In this study, we aimed to investigate the clinical significance of the angiography-based IMR calculation method (AccuIMR) and its prognostic assessment capability by evaluating the concordance or discordance between AccuIMR values and cardiac magnetic resonance (CMR) results. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, STEMI - ST Elevation Myocardial Infarction, Microvascular Coronary Artery Disease
- What is being tested?
- CMR
- How many people
- 843 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2012to 31 Dec 2024
- 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: STEMI patients who underwent PCI within 12 hours of symptom onset, and coronary microvascular function was assessed using contrast-enhanced CMR after PCI.
Who may be able to join
- (1) STEMI patients who underwent PCI within 12 hours of symptom onset.
- (2) coronary microvascular function was assessed using contrast-enhanced CMR after PCI.
Who cannot join
- (1) Suboptimal coronary angiographic images, including inadequate contrast opacification, unsatisfactory projection view, and severe overlap or distortion of the target vessel.
- (2) Lacking two angiographic projections separated by at least 25° apart post-PCI.
- (3) Inadequate CMR image quality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Angiography-derived Index of Microcirculatory Resistance Predicts Microvascular Obstruction and Infarct Size in Patients With ST-segment-elevation Myocardial Infarction
In this study, we aimed to investigate the clinical significance of the angiography-based IMR calculation method (AccuIMR) and its prognostic assessment capability by evaluating the concordance or discordance between AccuIMR values and cardiac magnetic resonance (CMR) results.
- Conditions
- Coronary Artery Disease, STEMI - ST Elevation Myocardial Infarction, Microvascular Coronary Artery Disease
- Being tested
- CMR
- Keywords
- AccuIMR, CMR, infarct size
- Medical subject headings
- Coronary Artery Disease, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMRDiagnostic test
Coronary microvascular function was assessed using contrast-enhanced CMR after PCI.
| Study group | Role | What they receive |
|---|---|---|
| STEMI patients underwent CMR | STEMI patients who underwent PCI within 12 hours of symptom onset. Receives: Diagnostic Test: CMR |
What is being measured
The primary outcome is the main question the study is designed to answer.
CMR
Contrast-enhanced CMR was performed on a 3.0-T scanner (Achieva TX, Philips Healthcare, Best, The Netherlands) . All sequences were acquired during breath-hold with a field of view at 350 × 350 mm2. Two experienced readers, blinded to clinical data, evaluated the CMR results using validated software (QMass MR 7.5, Medis, Leiden, The Netherlands). The acquired images were utilized to assess ventricular parameters and calculate the left ventricular ejection fraction (LVEF).
Measured: CMR was performed at a median of 5 days post-reperfusion.
Secondary outcomes (2)
LDL-C, mmol/L
Low-density cholesterol (LDL-C) is the cholesterol in low-density lipoprotein (LDL), which reflects how much LDL is present.
Measured: Blood samples were collected after a 12-hour fast in the second day post-PCI.
HbA1c, %
Hemoglobin a1c (HbA1c) is the combination of hemoglobin and blood sugar. Its concentration in the blood is stable and is not affected by short-term blood sugar concentrations. Hemoglobin A1C has obvious clinical value in the diagnosis of diabetes.
Measured: Blood samples were collected after a 12-hour fast in the second day post-PCI.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start1 Jan 2012
- Primary completion31 Dec 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 843 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Pu, MD, PhD, Study chair, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06947564
- Sponsor's protocol ID
- Early MYO IMR-CMR
- Status last verified
- Apr 2025
- First submitted
- 20 Apr 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tsao CW, Aday AW, Almarzooq ZI, Alonso A, Beaton AZ, Bittencourt MS, Boehme AK, Buxton AE, Carson AP, Commodore-Mensah Y, Elkind MSV, Evenson KR, Eze-Nliam C, Ferguson JF, Generoso G, Ho JE, Kalani R, Khan SS, Kissela BM, Knutson KL, Levine DA, Lewis TT, Liu J, Loop MS, Ma J, Mussolino ME, Navaneethan SD, Perak AM, Poudel R, Rezk-Hanna M, Roth GA, Schroeder EB, Shah SH, Thacker EL, VanWagner LB, Virani SS, Voecks JH, Wang NY, Yaffe K, Martin SS. Heart Disease and Stroke Statistics-2022 Update: A Report From the American Heart Association. Circulation. 2022 Feb 22;145(8):e153-e639. doi: 10.1161/CIR.0000000000001052. Epub 2022 Jan 26.
PubMed 35078371Frampton J, Devries JT, Welch TD, Gersh BJ. Modern Management of ST-Segment Elevation Myocardial Infarction. Curr Probl Cardiol. 2020 Mar;45(3):100393. doi: 10.1016/j.cpcardiol.2018.08.005. Epub 2018 Sep 14.
PubMed 30660333Gibson CM, Cannon CP, Murphy SA, Ryan KA, Mesley R, Marble SJ, McCabe CH, Van De Werf F, Braunwald E. Relationship of TIMI myocardial perfusion grade to mortality after administration of thrombolytic drugs. Circulation. 2000 Jan 18;101(2):125-30. doi: 10.1161/01.cir.101.2.125.
PubMed 10637197Fearon WF, Shah M, Ng M, Brinton T, Wilson A, Tremmel JA, Schnittger I, Lee DP, Vagelos RH, Fitzgerald PJ, Yock PG, Yeung AC. Predictive value of the index of microcirculatory resistance in patients with ST-segment elevation myocardial infarction. J Am Coll Cardiol. 2008 Feb 5;51(5):560-5. doi: 10.1016/j.jacc.2007.08.062.
PubMed 18237685Fearon WF, Low AF, Yong AS, McGeoch R, Berry C, Shah MG, Ho MY, Kim HS, Loh JP, Oldroyd KG. Prognostic value of the Index of Microcirculatory Resistance measured after primary percutaneous coronary intervention. Circulation. 2013 Jun 18;127(24):2436-41. doi: 10.1161/CIRCULATIONAHA.112.000298. Epub 2013 May 16.
PubMed 23681066Scarsini R, Kotronias RA, Della Mora F, Portolan L, Andreaggi S, Benenati S, Marin F, Sgreva S, Comuzzi A, Butturini C, Pesarini G, Tavella D, Channon KM, Garcia Garcia HM, Ribichini F, Banning AP, De Maria GL. Angiography-Derived Index of Microcirculatory Resistance to Define the Risk of Early Discharge in STEMI. Circ Cardiovasc Interv. 2024 Mar;17(3):e013556. doi: 10.1161/CIRCINTERVENTIONS.123.013556. Epub 2024 Feb 20.
PubMed 38375667Jiang J, Li C, Hu Y, Li C, He J, Leng X, Xiang J, Ge J, Wang J. A novel CFD-based computed index of microcirculatory resistance (IMR) derived from coronary angiography to assess coronary microcirculation. Comput Methods Programs Biomed. 2022 Jun;221:106897. doi: 10.1016/j.cmpb.2022.106897. Epub 2022 May 18.
PubMed 35636354Zhang Y, Pu J, Niu T, Fang J, Chen D, Yidilisi A, Zheng Y, Lu J, Hu Y, Koo BK, Xiang J, Wang J, Jiang J. Prognostic Value of Coronary Angiography-Derived Index of Microcirculatory Resistance in Non-ST-Segment Elevation Myocardial Infarction Patients. JACC Cardiovasc Interv. 2024 Aug 26;17(16):1874-1886. doi: 10.1016/j.jcin.2024.04.048. Epub 2024 Aug 7.
PubMed 39115479Yidilisi A, Chen D, Zhang Y, Pu J, Niu T, Hu Y, Fang J, Gong Q, Zheng Y, Huang J, Xiang J, Wang Y, Wang J, Jiang J. Coronary Angiography-Derived Index of Microcirculatory Resistance Predicts Outcome in Patients With ST-Segment-Elevation Myocardial Infarction. Circ Cardiovasc Interv. 2024 May;17(5):e013899. doi: 10.1161/CIRCINTERVENTIONS.123.013899. Epub 2024 Apr 25. No abstract available.
PubMed 38660822Fan Y, Li C, Hu Y, Hu X, Wang S, He J, Leng X, Xiang J, Lu Z. Angiography-based index of microcirculatory resistance (AccuIMR) for the assessment of microvascular dysfunction in acute coronary syndrome and chronic coronary syndrome. Quant Imaging Med Surg. 2023 Jun 1;13(6):3556-3568. doi: 10.21037/qims-22-961. Epub 2023 Apr 17.
PubMed 37284070Symons R, Pontone G, Schwitter J, Francone M, Iglesias JF, Barison A, Zalewski J, de Luca L, Degrauwe S, Claus P, Guglielmo M, Nessler J, Carbone I, Ferro G, Durak M, Magistrelli P, Lo Presti A, Aquaro GD, Eeckhout E, Roguelov C, Andreini D, Vogt P, Guaricci AI, Mushtaq S, Lorenzoni V, Muller O, Desmet W, Agati L, Janssens S, Bogaert J, Masci PG. Long-Term Incremental Prognostic Value of Cardiovascular Magnetic Resonance After ST-Segment Elevation Myocardial Infarction: A Study of the Collaborative Registry on CMR in STEMI. JACC Cardiovasc Imaging. 2018 Jun;11(6):813-825. doi: 10.1016/j.jcmg.2017.05.023. Epub 2017 Aug 16.
PubMed 28823746De Maria GL, Alkhalil M, Wolfrum M, Fahrni G, Borlotti A, Gaughran L, Dawkins S, Langrish JP, Lucking AJ, Choudhury RP, Porto I, Crea F, Dall'Armellina E, Channon KM, Kharbanda RK, Banning AP. Index of Microcirculatory Resistance as a Tool to Characterize Microvascular Obstruction and to Predict Infarct Size Regression in Patients With STEMI Undergoing Primary PCI. JACC Cardiovasc Imaging. 2019 May;12(5):837-848. doi: 10.1016/j.jcmg.2018.02.018. Epub 2018 Apr 18.
PubMed 29680355Qi Y, Gu R, Xu J, Kang L, Liu Y, Wang L, Chen J, Zhang J, Wang K. Index of microcirculatory resistance predicts long term cardiac systolic function in patients with STEMI undergoing primary PCI. BMC Cardiovasc Disord. 2021 Feb 2;21(1):66. doi: 10.1186/s12872-021-01887-w.
PubMed 33530931Sheng X, Hu Y, Zhang Y, Chen J, Xiang J, Ding S, Pu J. Angiography-Derived Index of Microcirculatory Resistance Predicts Microvascular Obstruction and Infarct Size in Patients With STEMI. JACC Asia. 2026 Jul 28:S2772-3747(26)00445-X. doi: 10.1016/j.jacasi.2026.06.013. Online ahead of print.
PubMed 42541504
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Angiography-derived Index of Microcirculatory Resistance Predicts Microvascular Obstruction and Infarct Size in Patients With ST-segment-elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT06947564
- Acronym / sponsor ID
- Early MYO IMR-CMR
- Conditions
- Coronary Artery Disease, STEMI - ST Elevation Myocardial Infarction, Microvascular Coronary Artery Disease
- Keywords
- AccuIMR, CMR, infarct size
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 843 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 27 Apr 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.
In this study, we aimed to investigate the clinical significance of the angiography-based IMR calculation method (AccuIMR) and its prognostic assessment capability by evaluating the concordance or discordance between AccuIMR values and cardiac magnetic resonance (CMR) results.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STEMI patients underwent CMR | – | Diagnostic Test: CMRSTEMI patients who underwent PCI within 12 hours of symptom onset. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- STEMI patients who underwent PCI within 12 hours of symptom onset, and coronary microvascular function was assessed using contrast-enhanced CMR after PCI.
Key inclusion criteria (2 listed)
- (1) STEMI patients who underwent PCI within 12 hours of symptom onset.
- (2) coronary microvascular function was assessed using contrast-enhanced CMR after PCI.
Key exclusion criteria (3 listed)
- (1) Suboptimal coronary angiographic images, including inadequate contrast opacification, unsatisfactory projection view, and severe overlap or distortion of the target vessel.
- (2) Lacking two angiographic projections separated by at least 25° apart post-PCI.
- (3) Inadequate CMR image quality
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 |
|---|---|---|
| CMRCoronary microvascular function was assessed using contrast-enhanced CMR after PCI. | Diagnostic test | STEMI patients underwent CMR |
Primary outcome
CMR
Time frame: CMR was performed at a median of 5 days post-reperfusion.
Contrast-enhanced CMR was performed on a 3.0-T scanner (Achieva TX, Philips Healthcare, Best, The Netherlands) . All sequences were acquired during breath-hold with a field of view at 350 × 350 mm2. Two experienced readers, blinded to clinical data, evaluated the CMR results using validated software (QMass MR 7.5, Medis, Leiden, The Netherlands). The acquired images were utilized to assess ventricular parameters and calculate the left ventricular ejection fraction (LVEF).
2 secondary outcomes
LDL-C, mmol/L
Time frame: Blood samples were collected after a 12-hour fast in the second day post-PCI.
HbA1c, %
Time frame: Blood samples were collected after a 12-hour fast in the second day post-PCI.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Background: PubMed 35078371Tsao CW, Aday AW, Almarzooq ZI, Alonso A, Beaton AZ, Bittencourt MS, Boehme AK, Buxton AE, Carson AP, Commodore-Mensah Y, Elkind MSV, Evenson KR, Eze-Nliam C, Ferguson JF, Generoso G, Ho JE, Kalani R, Khan SS, Kissela BM, Knutson KL, Levine DA, Lewis TT, Liu J, Loop MS, Ma J, Mussolino ME, Navaneethan SD, Perak AM, Poudel R, Rezk-Hanna M, Roth GA, Schroeder EB, Shah SH, Thacker EL, VanWagner LB, Virani SS, Voecks JH, Wang NY, Yaffe K, Martin SS. Heart Disease and Stroke Statistics-2022 Update: A Report From the American Heart Association. Circulation. 2022 Feb 22;145(8):e153-e639. doi: 10.1161/CIR.0000000000001052. Epub 2022 Jan 26.
- Background: PubMed 30660333Frampton J, Devries JT, Welch TD, Gersh BJ. Modern Management of ST-Segment Elevation Myocardial Infarction. Curr Probl Cardiol. 2020 Mar;45(3):100393. doi: 10.1016/j.cpcardiol.2018.08.005. Epub 2018 Sep 14.
- Background: PubMed 10637197Gibson CM, Cannon CP, Murphy SA, Ryan KA, Mesley R, Marble SJ, McCabe CH, Van De Werf F, Braunwald E. Relationship of TIMI myocardial perfusion grade to mortality after administration of thrombolytic drugs. Circulation. 2000 Jan 18;101(2):125-30. doi: 10.1161/01.cir.101.2.125.
- Background: PubMed 18237685Fearon WF, Shah M, Ng M, Brinton T, Wilson A, Tremmel JA, Schnittger I, Lee DP, Vagelos RH, Fitzgerald PJ, Yock PG, Yeung AC. Predictive value of the index of microcirculatory resistance in patients with ST-segment elevation myocardial infarction. J Am Coll Cardiol. 2008 Feb 5;51(5):560-5. doi: 10.1016/j.jacc.2007.08.062.
- Background: PubMed 23681066Fearon WF, Low AF, Yong AS, McGeoch R, Berry C, Shah MG, Ho MY, Kim HS, Loh JP, Oldroyd KG. Prognostic value of the Index of Microcirculatory Resistance measured after primary percutaneous coronary intervention. Circulation. 2013 Jun 18;127(24):2436-41. doi: 10.1161/CIRCULATIONAHA.112.000298. Epub 2013 May 16.
- Background: PubMed 38375667Scarsini R, Kotronias RA, Della Mora F, Portolan L, Andreaggi S, Benenati S, Marin F, Sgreva S, Comuzzi A, Butturini C, Pesarini G, Tavella D, Channon KM, Garcia Garcia HM, Ribichini F, Banning AP, De Maria GL. Angiography-Derived Index of Microcirculatory Resistance to Define the Risk of Early Discharge in STEMI. Circ Cardiovasc Interv. 2024 Mar;17(3):e013556. doi: 10.1161/CIRCINTERVENTIONS.123.013556. Epub 2024 Feb 20.
- Background: PubMed 35636354Jiang J, Li C, Hu Y, Li C, He J, Leng X, Xiang J, Ge J, Wang J. A novel CFD-based computed index of microcirculatory resistance (IMR) derived from coronary angiography to assess coronary microcirculation. Comput Methods Programs Biomed. 2022 Jun;221:106897. doi: 10.1016/j.cmpb.2022.106897. Epub 2022 May 18.
- Background: PubMed 39115479Zhang Y, Pu J, Niu T, Fang J, Chen D, Yidilisi A, Zheng Y, Lu J, Hu Y, Koo BK, Xiang J, Wang J, Jiang J. Prognostic Value of Coronary Angiography-Derived Index of Microcirculatory Resistance in Non-ST-Segment Elevation Myocardial Infarction Patients. JACC Cardiovasc Interv. 2024 Aug 26;17(16):1874-1886. doi: 10.1016/j.jcin.2024.04.048. Epub 2024 Aug 7.
- Background: PubMed 38660822Yidilisi A, Chen D, Zhang Y, Pu J, Niu T, Hu Y, Fang J, Gong Q, Zheng Y, Huang J, Xiang J, Wang Y, Wang J, Jiang J. Coronary Angiography-Derived Index of Microcirculatory Resistance Predicts Outcome in Patients With ST-Segment-Elevation Myocardial Infarction. Circ Cardiovasc Interv. 2024 May;17(5):e013899. doi: 10.1161/CIRCINTERVENTIONS.123.013899. Epub 2024 Apr 25. No abstract available.
- Background: PubMed 37284070Fan Y, Li C, Hu Y, Hu X, Wang S, He J, Leng X, Xiang J, Lu Z. Angiography-based index of microcirculatory resistance (AccuIMR) for the assessment of microvascular dysfunction in acute coronary syndrome and chronic coronary syndrome. Quant Imaging Med Surg. 2023 Jun 1;13(6):3556-3568. doi: 10.21037/qims-22-961. Epub 2023 Apr 17.
- Background: PubMed 28823746Symons R, Pontone G, Schwitter J, Francone M, Iglesias JF, Barison A, Zalewski J, de Luca L, Degrauwe S, Claus P, Guglielmo M, Nessler J, Carbone I, Ferro G, Durak M, Magistrelli P, Lo Presti A, Aquaro GD, Eeckhout E, Roguelov C, Andreini D, Vogt P, Guaricci AI, Mushtaq S, Lorenzoni V, Muller O, Desmet W, Agati L, Janssens S, Bogaert J, Masci PG. Long-Term Incremental Prognostic Value of Cardiovascular Magnetic Resonance After ST-Segment Elevation Myocardial Infarction: A Study of the Collaborative Registry on CMR in STEMI. JACC Cardiovasc Imaging. 2018 Jun;11(6):813-825. doi: 10.1016/j.jcmg.2017.05.023. Epub 2017 Aug 16.
- Background: PubMed 29680355De Maria GL, Alkhalil M, Wolfrum M, Fahrni G, Borlotti A, Gaughran L, Dawkins S, Langrish JP, Lucking AJ, Choudhury RP, Porto I, Crea F, Dall'Armellina E, Channon KM, Kharbanda RK, Banning AP. Index of Microcirculatory Resistance as a Tool to Characterize Microvascular Obstruction and to Predict Infarct Size Regression in Patients With STEMI Undergoing Primary PCI. JACC Cardiovasc Imaging. 2019 May;12(5):837-848. doi: 10.1016/j.jcmg.2018.02.018. Epub 2018 Apr 18.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Pu, MD, PhD study chair
RenJi Hospital
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 Coronary Artery Disease and STEMI - ST Elevation Myocardial Infarction, run by RenJi Hospital at 1 site in China.
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 2 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: finished, as of the sponsor's last update on 27 Apr 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 China. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
CMR (time frame: CMR was performed at a median of 5 days post-reperfusion.). 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 NCT06947564, which also lists 14 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 27 Apr 2025.