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

NCT05009667 | Completed DMC

• 1 other identifier: Flash III
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Coronary Microvascular Dysfunction

Keywords

Hemodynamics; Computational fluid dynamics; Index of microcirculatory resistance; Fractional flow reserve; Angiography-derived IMR

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy

  To compare diagnostic accuracy of caIMR for coronary microvascular dysfunction with IMR as control.

  Through study completion, an average of 7 months.

Secondary Outcomes (3)

• Sensitivity, specificity, positive predictive value, and negative predictive value

  Through study completion, an average of 7 months.

• ROC curve, and AUC

  Through study completion, an average of 7 months.

• Diagnostic performance on the vessel level

  Through study completion, an average of 7 months.

Study Arms (2)

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.

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.

Device: Angiography-derived Index of Microcirculatory Resistance; Device: Pressure wire-based Index of Microcirculatory Resistance

Interventions

Angiography-derived Index of Microcirculatory Resistance DEVICE

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.

IMR first group; caIMR first group

Pressure wire-based Index of Microcirculatory Resistance DEVICE

IMR will be measured by thermodilution method with pressure wire and arterial physiological detector which are produced by St. Jude Medical. IMR = Pd ∙Tmn

IMR first group; caIMR first group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with stable or unstable angina, or suspected myocardial ischemia.

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Ge Junbo: lead
• RainMed Medical Group: collaborator

Study Sites (3)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Zhongnan Hospital Of Wuhan Uniersity

Wuhan, Hubei, 430062, China

Location

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (12)

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  PMID: 32626906 BACKGROUND

• 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.

  PMID: 14568891 BACKGROUND

• 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.

  PMID: 33391020 BACKGROUND

• 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.

  PMID: 15466646 BACKGROUND

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  PMID: 29146670 BACKGROUND

• 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.

  PMID: 18602508 BACKGROUND

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  PMID: 29132649 BACKGROUND

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  PMID: 29680355 BACKGROUND

• 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.

  PMID: 37054908 DERIVED

Study Officials

• Junbo Ge, PHD

  Fudan University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Coordinating Investigator

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: August 17, 2021
• Study Start: October 14, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 6, 2022

Record last verified: 2022-03

Locations

CN (3)