Coronary Microvascular DysfunctionFlash IIINCT05009667

A Prospective, Multi-center Clinical Trial for Evaluating the Effectiveness and Safety of Online Coronary Angiography-Derived Index of Microcirculatory Resistance (caIMR)

An observational study of Coronary Microvascular Dysfunction, run by Ge Junbo at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Coronary Microvascular Dysfunction
What is being tested?: Angiography-derived Index of Microcirculatory Resistance and Pressure wire-based Index of Microcirculatory Resistance
Type of treatment: Medical device
How many people: 116 participants
Where: 3 sitesChina
Study dates: 14 Oct 2021to 31 Dec 2021
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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients with stable or unstable angina, or suspected myocardial ischemia.

Who may be able to join

Patients aged 18 years and above, 80 years old and below, with no gender limitation;
Patients with stable or unstable angina or suspected myocardial ischemia;
Patients voluntarily participated in this clinical trial and signed an informed consent form;
Target coronary with <50% diameter stenosis (DS%) by visual estimation.

Who cannot join

Patients with suspected acute myocardial infarction;
Patients with old myocardial infarction;
Patients with primary or secondary cardiomyopathy;
Patients with primary or secondary heart valve disease;
Patients with severe cardiac insufficiency and LVEF≤35%;
Patients with renal insufficiency (eGFR<60ml/min (1.73m^2)) or patients undergoing dialysis;

Show all 15Show fewer

Patients who are allergic to iodine contrast agents, adenosine, and ATP;
Patients with severe organ disease or life expectancy less than 24 months;
Patients who are participating in other clinical studies of investigational drugs or devices and have not reached their primary endpoint;
The patient who has other conditions that are not suitable for clinical trials;
Patients with coronary artery involved in coronary fistula and myocardial bridge;
The contrast media is not filled, the blood vessels are overlapped, or the target blood vessel is severely distorted, and the lesion location cannot be fully exposed, or the image quality is poor and cannot be recognized;
Left main coronary artery disease and right coronary artery orifice disease;
After angiography, the investigator believes that the patient cannot tolerate any of the detection methods between caIMR and IMR;
The investigator believes that the patient is not suitable for clinical trials after angiography;

Trial locations and contacts

3 sites in 1 country.

China3 sites

Peking University First Hospital
Beijing, Beijing Municipality, 100034
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Zhongnan Hospital Of Wuhan Uniersity
Wuhan, Hubei, 430062

Other trials in China

About this study

Official title: A Prospective, Multi-center Clinical Trial for Evaluating the Effectiveness and Safety of Coronary Angiography-Derived Index of Microcirculatory Resistance Measured Online by a Coronary Functional Measurement System

More than 50% of patients with stable or unstable angina pectoris have no obstructive coronary arteries by angiographic visual estimation, in which coronary microvascular dysfunction (CMD) is one of the causes of myocardial ischemia and chest pain. A coronary angiography-derived index of microcirculatory resistance (caIMR) is proposed for physiological assessment of microvascular diseases in coronary circulation. The aim of the trial is to assess diagnostic performance of caIMR, using wire-derived index of microcirculatory resistance (IMR) as the reference standard.

Read the detailed description

More than 50% of patients with stable or unstable angina pectoris have no obstructive coronary arteries by angiographic visual estimation, in which coronary microvascular dysfunction (CMD) is one of the causes of myocardial ischemia and chest pain. Presently, the index of microcirculatory resistance (IMR) measured by the pressure wire is recognized as standard for evaluating coronary microcirculatory function. A coronary angiography-derived index of microcirculatory resistance (caIMR) is proposed for physiological assessment of microvascular diseases in coronary circulation without pressure wire, hyperemic agents, or thermodilution method.

This study is a prospective, multi-center clinical trial. In the study, IMR (measured by pressure wire) will be used as a reference standard to evaluate the feasibility, accuracy and safety of caIMR measured by a non-invasive diagnosis system (FM21a) based on angiography images and aortic pressure wave. 116 patients eligible for inclusion criteria will be enrolled in the study. Both IMR and caIMR measurement will be performed in the same patient in a random order after angiography. The definitions of IMR and caIMR for coronary microcirculatory ischemia are IMR≥25 and caIMR≥25. The primary endpoint is the diagnostic accuracy of caIMR. The secondary endpoint is caIMR's sensitivity, specificity, positive predictive value, negative predictive value, ROC curve and AUC of caIMR diagnosis, and the diagnostic characteristics of caIMR at the vascular level.

Conditions: Coronary Microvascular Dysfunction
Being tested: Angiography-derived Index of Microcirculatory Resistance, Pressure wire-based Index of Microcirculatory Resistance
Keywords: Hemodynamics, Computational fluid dynamics, Index of microcirculatory resistance, Fractional flow reserve, Angiography-derived IMR

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Angiography-derived Index of Microcirculatory ResistanceDevice
caIMR will be measured by pressure sensors which are produced by Suzhou Rainmed Medical Technology Co., Ltd.
caIMR is calculated based on angiography images and Hyperemic Pa estimated from resting Pa according to prespecified equation.
Pressure wire-based Index of Microcirculatory ResistanceDevice
IMR will be measured by thermodilution method with pressure wire and arterial physiological detector which are produced by St. Jude Medical.
IMR = Pd ∙Tmn

Study groups in NCT05009667
Study group	Role	What they receive
IMR first group		In this group, IMR based on pressure wire and arterial physiological detector will be measured first, and then caIMR base on angiography images and pressure sensor will be measured secondly. Receives: Device: Angiography-derived Index of Microcirculatory Resistance; Device: Pressure wire-based Index of Microcirculatory Resistance
caIMR first group		In this group, caIMR based on angiography images and pressure sensor will be measured first, and then IMR based on pressure wire and arterial physiological detector will be measured secondly. Receives: Device: Angiography-derived Index of Microcirculatory Resistance; Device: Pressure wire-based Index of Microcirculatory Resistance

What is being measured

The primary outcome is the main question the study is designed to answer.

Diagnostic accuracy
To compare diagnostic accuracy of caIMR for coronary microvascular dysfunction with IMR as control.
Measured: Through study completion, an average of 7 months.

Secondary outcomes (3)

Sensitivity, specificity, positive predictive value, and negative predictive value
To compare the diagnostic performance between caIMR and IMR in the patient level, with IMR as the reference standard.
Measured: Through study completion, an average of 7 months.
ROC curve, and AUC
Using IMR as reference standard, draw the ROC curve of caIMR. The definition of ischemia is IMR≥25.
Measured: Through study completion, an average of 7 months.
Diagnostic performance on the vessel level
The diagnostic features of caIMR compared with IMR on the vessel level.
Measured: Through study completion, an average of 7 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Oct 202131 Dec 2021

First posted17 Aug 2021
Study start14 Oct 2021
Primary completion31 Dec 2021
Study completion31 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Coronary Microvascular DysfunctionStudies 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: 116 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05009667
Sponsor's protocol ID: Flash III
Acronym: Flash III
Status last verified: Mar 2022
First submitted: 23 Jul 2021
Last updated: 6 Apr 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Li J, Gong Y, Wang W, Yang Q, Liu B, Lu Y, Xu Y, Huo Y, Yi T, Liu J, Li Y, Xu S, Zhao L, Ali ZA, Huo Y. Accuracy of computational pressure-fluid dynamics applied to coronary angiography to derive fractional flow reserve: FLASH FFR. Cardiovasc Res. 2020 Jun 1;116(7):1349-1356. doi: 10.1093/cvr/cvz289.
PubMed 31693092
Fearon WF, Balsam LB, Farouque HM, Caffarelli AD, Robbins RC, Fitzgerald PJ, Yock PG, Yeung AC. Novel index for invasively assessing the coronary microcirculation. Circulation. 2003 Jul 1;107(25):3129-32. doi: 10.1161/01.CIR.0000080700.98607.D1. Epub 2003 Jun 23.
PubMed 12821539
Ford TJ, Berry C. How to Diagnose and Manage Angina Without Obstructive Coronary Artery Disease: Lessons from the British Heart Foundation CorMicA Trial. Interv Cardiol. 2019 May 21;14(2):76-82. doi: 10.15420/icr.2019.04.R1. eCollection 2019 May.
PubMed 31178933
Kunadian V, Chieffo A, Camici PG, Berry C, Escaned J, Maas AHEM, Prescott E, Karam N, Appelman Y, Fraccaro C, Louise Buchanan G, Manzo-Silberman S, Al-Lamee R, Regar E, Lansky A, Abbott JD, Badimon L, Duncker DJ, Mehran R, Capodanno D, Baumbach A. An EAPCI Expert Consensus Document on Ischaemia with Non-Obstructive Coronary Arteries in Collaboration with European Society of Cardiology Working Group on Coronary Pathophysiology & Microcirculation Endorsed by Coronary Vasomotor Disorders International Study Group. Eur Heart J. 2020 Oct 1;41(37):3504-3520. doi: 10.1093/eurheartj/ehaa503.
PubMed 32626906
Fearon WF, Farouque HM, Balsam LB, Caffarelli AD, Cooke DT, Robbins RC, Fitzgerald PJ, Yeung AC, Yock PG. Comparison of coronary thermodilution and Doppler velocity for assessing coronary flow reserve. Circulation. 2003 Nov 4;108(18):2198-200. doi: 10.1161/01.CIR.0000099521.31396.9D. Epub 2003 Oct 20.
PubMed 14568891
Ai H, Feng Y, Gong Y, Zheng B, Jin Q, Zhang HP, Sun F, Li J, Chen Y, Huo Y, Huo Y. Coronary Angiography-Derived Index of Microvascular Resistance. Front Physiol. 2020 Dec 16;11:605356. doi: 10.3389/fphys.2020.605356. eCollection 2020.
PubMed 33391020
Aarnoudse W, Fearon WF, Manoharan G, Geven M, van de Vosse F, Rutten M, De Bruyne B, Pijls NH. Epicardial stenosis severity does not affect minimal microcirculatory resistance. Circulation. 2004 Oct 12;110(15):2137-42. doi: 10.1161/01.CIR.0000143893.18451.0E. Epub 2004 Oct 4.
PubMed 15466646
Kobayashi Y, Lee JM, Fearon WF, Lee JH, Nishi T, Choi DH, Zimmermann FM, Jung JH, Lee HJ, Doh JH, Nam CW, Shin ES, Koo BK. Three-Vessel Assessment of Coronary Microvascular Dysfunction in Patients With Clinical Suspicion of Ischemia: Prospective Observational Study With the Index of Microcirculatory Resistance. Circ Cardiovasc Interv. 2017 Nov;10(11):e005445. doi: 10.1161/CIRCINTERVENTIONS.117.005445.
PubMed 29146670
Yoon MH, Tahk SJ, Yang HM, Woo SI, Lim HS, Kang SJ, Choi BJ, Choi SY, Hwang GS, Shin JH. Comparison of accuracy in the prediction of left ventricular wall motion changes between invasively assessed microvascular integrity indexes and fluorine-18 fluorodeoxyglucose positron emission tomography in patients with ST-elevation myocardial infarction. Am J Cardiol. 2008 Jul 15;102(2):129-34. doi: 10.1016/j.amjcard.2008.03.024. Epub 2008 May 29.
PubMed 18602508
Williams RP, de Waard GA, De Silva K, Lumley M, Asrress K, Arri S, Ellis H, Mir A, Clapp B, Chiribiri A, Plein S, Teunissen PF, Hollander MR, Marber M, Redwood S, van Royen N, Perera D. Doppler Versus Thermodilution-Derived Coronary Microvascular Resistance to Predict Coronary Microvascular Dysfunction in Patients With Acute Myocardial Infarction or Stable Angina Pectoris. Am J Cardiol. 2018 Jan 1;121(1):1-8. doi: 10.1016/j.amjcard.2017.09.012. Epub 2017 Oct 10.
PubMed 29132649
De 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 29680355
Huang D, Gong Y, Fan Y, Zheng B, Lu Z, Li J, Huo Y, Escaned J, Huo Y, Ge J. Coronary angiography-derived index for assessing microcirculatory resistance in patients with non-obstructed vessels: The FLASH IMR study. Am Heart J. 2023 Sep;263:56-63. doi: 10.1016/j.ahj.2023.03.016. Epub 2023 Apr 12.
PubMed 37054908

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multi-center Clinical Trial for Evaluating the Effectiveness and Safety of Coronary Angiography-Derived Index of Microcirculatory Resistance Measured Online by a Coronary Functional Measurement System
ClinicalTrials.gov ID: NCT05009667
Acronym / sponsor ID: Flash III / Flash III
Conditions: Coronary Microvascular Dysfunction
Keywords: Hemodynamics, Computational fluid dynamics, Index of microcirculatory resistance, Fractional flow reserve, Angiography-derived IMR
Study type: Observational
Recruitment status: Completed
Enrolment: 116 participants (actual)
Lead sponsor: Ge JunboUniversity, hospital or other
Collaborators: RainMed Medical Group
Study start: 14 Oct 2021 (actual)
Primary completion: 31 Dec 2021 (actual)
Study completion: 31 Dec 2021 (actual)
First posted: 17 Aug 2021 (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.

Detailed description

More than 50% of patients with stable or unstable angina pectoris have no obstructive coronary arteries by angiographic visual estimation, in which coronary microvascular dysfunction (CMD) is one of the causes of myocardial ischemia and chest pain. Presently, the index of microcirculatory resistance (IMR) measured by the pressure wire is recognized as standard for evaluating coronary microcirculatory function. A coronary angiography-derived index of microcirculatory resistance (caIMR) is proposed for physiological assessment of microvascular diseases in coronary circulation without pressure wire, hyperemic agents, or thermodilution method.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
IMR first group	–	Device: Angiography-derived Index of Microcirculatory Resistance, Device: Pressure wire-based Index of Microcirculatory ResistanceIn this group, IMR based on pressure wire and arterial physiological detector will be measured first, and then caIMR base on angiography images and pressure sensor will be measured secondly.
caIMR first group	–	Device: Angiography-derived Index of Microcirculatory Resistance, Device: Pressure wire-based Index of Microcirculatory ResistanceIn this group, caIMR based on angiography images and pressure sensor will be measured first, and then IMR based on pressure wire and arterial physiological detector will be measured secondly.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with stable or unstable angina, or suspected myocardial ischemia.

Key inclusion criteria (4 listed)

Patients aged 18 years and above, 80 years old and below, with no gender limitation;
Patients with stable or unstable angina or suspected myocardial ischemia;
Patients voluntarily participated in this clinical trial and signed an informed consent form;
Target coronary with <50% diameter stenosis (DS%) by visual estimation.

Key exclusion criteria (15 listed)

Patients with suspected acute myocardial infarction;
Patients with old myocardial infarction;
Patients with primary or secondary cardiomyopathy;
Patients with primary or secondary heart valve disease;
Patients with severe cardiac insufficiency and LVEF≤35%;

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
Angiography-derived Index of Microcirculatory ResistancecaIMR will be measured by pressure sensors which are produced by Suzhou Rainmed Medical Technology Co., Ltd. caIMR is calculated based on angiography images and Hyperemic Pa estimated from resting Pa according to prespecified equation.	Device	IMR first group, caIMR first group
Pressure wire-based Index of Microcirculatory ResistanceIMR will be measured by thermodilution method with pressure wire and arterial physiological detector which are produced by St. Jude Medical. IMR = Pd ∙Tmn	Device	IMR first group, caIMR first group

Primary outcome

Diagnostic accuracy
Time frame: Through study completion, an average of 7 months.
To compare diagnostic accuracy of caIMR for coronary microvascular dysfunction with IMR as control.

3 secondary outcomes

Sensitivity, specificity, positive predictive value, and negative predictive value
Time frame: Through study completion, an average of 7 months.
ROC curve, and AUC
Time frame: Through study completion, an average of 7 months.
Diagnostic performance on the vessel level
Time frame: Through study completion, an average of 7 months.

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 6 Apr 2022.
Background: PubMed 31693092Li J, Gong Y, Wang W, Yang Q, Liu B, Lu Y, Xu Y, Huo Y, Yi T, Liu J, Li Y, Xu S, Zhao L, Ali ZA, Huo Y. Accuracy of computational pressure-fluid dynamics applied to coronary angiography to derive fractional flow reserve: FLASH FFR. Cardiovasc Res. 2020 Jun 1;116(7):1349-1356. doi: 10.1093/cvr/cvz289.
Background: PubMed 12821539Fearon WF, Balsam LB, Farouque HM, Caffarelli AD, Robbins RC, Fitzgerald PJ, Yock PG, Yeung AC. Novel index for invasively assessing the coronary microcirculation. Circulation. 2003 Jul 1;107(25):3129-32. doi: 10.1161/01.CIR.0000080700.98607.D1. Epub 2003 Jun 23.
Background: PubMed 31178933Ford TJ, Berry C. How to Diagnose and Manage Angina Without Obstructive Coronary Artery Disease: Lessons from the British Heart Foundation CorMicA Trial. Interv Cardiol. 2019 May 21;14(2):76-82. doi: 10.15420/icr.2019.04.R1. eCollection 2019 May.
Background: PubMed 32626906Kunadian V, Chieffo A, Camici PG, Berry C, Escaned J, Maas AHEM, Prescott E, Karam N, Appelman Y, Fraccaro C, Louise Buchanan G, Manzo-Silberman S, Al-Lamee R, Regar E, Lansky A, Abbott JD, Badimon L, Duncker DJ, Mehran R, Capodanno D, Baumbach A. An EAPCI Expert Consensus Document on Ischaemia with Non-Obstructive Coronary Arteries in Collaboration with European Society of Cardiology Working Group on Coronary Pathophysiology & Microcirculation Endorsed by Coronary Vasomotor Disorders International Study Group. Eur Heart J. 2020 Oct 1;41(37):3504-3520. doi: 10.1093/eurheartj/ehaa503.
Background: PubMed 14568891Fearon WF, Farouque HM, Balsam LB, Caffarelli AD, Cooke DT, Robbins RC, Fitzgerald PJ, Yeung AC, Yock PG. Comparison of coronary thermodilution and Doppler velocity for assessing coronary flow reserve. Circulation. 2003 Nov 4;108(18):2198-200. doi: 10.1161/01.CIR.0000099521.31396.9D. Epub 2003 Oct 20.
Background: PubMed 33391020Ai H, Feng Y, Gong Y, Zheng B, Jin Q, Zhang HP, Sun F, Li J, Chen Y, Huo Y, Huo Y. Coronary Angiography-Derived Index of Microvascular Resistance. Front Physiol. 2020 Dec 16;11:605356. doi: 10.3389/fphys.2020.605356. eCollection 2020.
Background: PubMed 15466646Aarnoudse W, Fearon WF, Manoharan G, Geven M, van de Vosse F, Rutten M, De Bruyne B, Pijls NH. Epicardial stenosis severity does not affect minimal microcirculatory resistance. Circulation. 2004 Oct 12;110(15):2137-42. doi: 10.1161/01.CIR.0000143893.18451.0E. Epub 2004 Oct 4.
Background: PubMed 29146670Kobayashi Y, Lee JM, Fearon WF, Lee JH, Nishi T, Choi DH, Zimmermann FM, Jung JH, Lee HJ, Doh JH, Nam CW, Shin ES, Koo BK. Three-Vessel Assessment of Coronary Microvascular Dysfunction in Patients With Clinical Suspicion of Ischemia: Prospective Observational Study With the Index of Microcirculatory Resistance. Circ Cardiovasc Interv. 2017 Nov;10(11):e005445. doi: 10.1161/CIRCINTERVENTIONS.117.005445.
Background: PubMed 18602508Yoon MH, Tahk SJ, Yang HM, Woo SI, Lim HS, Kang SJ, Choi BJ, Choi SY, Hwang GS, Shin JH. Comparison of accuracy in the prediction of left ventricular wall motion changes between invasively assessed microvascular integrity indexes and fluorine-18 fluorodeoxyglucose positron emission tomography in patients with ST-elevation myocardial infarction. Am J Cardiol. 2008 Jul 15;102(2):129-34. doi: 10.1016/j.amjcard.2008.03.024. Epub 2008 May 29.
Background: PubMed 29132649Williams RP, de Waard GA, De Silva K, Lumley M, Asrress K, Arri S, Ellis H, Mir A, Clapp B, Chiribiri A, Plein S, Teunissen PF, Hollander MR, Marber M, Redwood S, van Royen N, Perera D. Doppler Versus Thermodilution-Derived Coronary Microvascular Resistance to Predict Coronary Microvascular Dysfunction in Patients With Acute Myocardial Infarction or Stable Angina Pectoris. Am J Cardiol. 2018 Jan 1;121(1):1-8. doi: 10.1016/j.amjcard.2017.09.012. Epub 2017 Oct 10.
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.
Derived from this study: PubMed 37054908Huang D, Gong Y, Fan Y, Zheng B, Lu Z, Li J, Huo Y, Escaned J, Huo Y, Ge J. Coronary angiography-derived index for assessing microcirculatory resistance in patients with non-obstructed vessels: The FLASH IMR study. Am Heart J. 2023 Sep;263:56-63. doi: 10.1016/j.ahj.2023.03.016. Epub 2023 Apr 12.
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.

Junbo Ge, PHD study director

Fudan University

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Microvascular Dysfunction, run by Ge Junbo at 3 sites 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 4 inclusion and 15 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 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Diagnostic accuracy (time frame: Through study completion, an average of 7 months.). 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 NCT05009667, which also lists 12 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 6 Apr 2022.