A Multi-center, Real-World Clinical Trial of caIMR on Two Specific Kinds of Patients.

NCT ID: NCT06945094

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 508 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2029-12-30

Brief Summary

The coronary angiography-derived index of microcirculatory resistance (caIMR) can be used to provide a binary assessment whether patients（with stable angina, unstable angina, suspected myocardial ischemia, or coronary artery stenosis of less than 50%, and without cardiomyopathy or obstructive epicardial coronary artery disease） have microcirculatory dysfunction, using a cutoff value of 25.

This study aims to evaluate the binary classification performance of caIMR in two specific groups of patients: (1) those with caIMR values between 20 and 30, and (2) those with diffuse disease. We will do this by looking at differences in their Seattle Angina Questionnaire (SAQ) scores and their health outcomes over a three-year period.

Detailed Description

The coronary angiography-derived index of microcirculatory resistance (caIMR) is a novel, non-invasive, imaging-based functional index for diagnosing coronary microvascular disease, which has been clinically validated for market release. It can be used to provide a binary assessment of whether patients with stable angina, unstable angina, suspected myocardial ischemia, or coronary artery stenosis of less than 50% (without cardiomyopathy or obstructive epicardial coronary artery disease) have microcirculatory dysfunction, using a cutoff value of 25.

This trial is a prospective, multicenter, observational real-world study. We will regularly collect clinical diagnostic data (including angiographic images) patients who undergo caIMR measurement using the Coronary Artery Functional Measurement System and single-use pressure sensors as part of their routine medical care. After verifying the inclusion and exclusion criteria, patients who meet the inclusion criteria and do not meet the exclusion criteria will be enrolled in this trial.

The primary objective of this trial is to evaluate the binary classification performance of caIMR by comparing patients' Seattle Angina Questionnaire (SAQ) scores before the procedure and at six months post-procedure in two specific groups of patients: :

1. Assessing the binary classification performance of caIMR in patients with values between 20 and 30.

2. Assessing the binary classification performance of caIMR in patients with diffuse disease.

The secondary objective is to validate the prognostic value of caIMR in these two groups of patients based on the occurrence of major adverse cardiovascular events (MACE) over a three-year period.

Conditions

Coronary Microvascular Dysfunction (CMD); Stable Angina Pectoris; Unstable Angina Pectoris; Myocardial Ischemia, Angina Pectoris

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Grey zone patients

Patients with caIMR values between 20 and 30 can be enrolled in this group, a total of 254 patients of this type will be enrolled in the study.The binary classification performance of caIMR will be validated based on differences in their Seattle Angina Questionnaire (SAQ) scores and their health outcomes.

caIMR

Intervention Type: 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

Diffuse disease patients.

Patients with diffuse coronary disease and less than 50% stenosis can be enrolled in this group, a total of 254 patients of this type will be enrolled in the study. CaIMR will be assessed in these patients, and its binary classification performance will be validated based on differences in their Seattle Angina Questionnaire (SAQ) scores and their health outcomes.

caIMR

Intervention Type: 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

Interventions

caIMR

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age between 18 and 80 years, regardless of gender;

2. Diagnosed with stable angina, unstable angina, or suspected myocardial ischemia;

3. targeted vessel stenosis < 50% and caIMR values between 20 and 30; or

(3) Targeted vessel stenosis < 50%, but with lesion length > 20 mm and caFFR > 0.8, representing diffuse disease.

Exclusion Criteria

1. Previously undergone percutaneous coronary intervention (PCI);

2. History of heart failure or myocardial infarction;

3. Acute myocardial infarction;

4. Primary or secondary cardiomyopathy;

5. Primary or secondary severe valvular heart disease;

6. Severe systemic infections;

7. Malignant cachectic diseases and an estimated survival of less than one year;

8. Patients who are currently participating in other clinical trials involving drugs or devices and have not yet reached the primary endpoint of those trials;

9. Patients whom the investigator deems to have other conditions that make them unsuitable for participation in the clinical trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RainMed Medical Group

INDUSTRY

Sponsor Role: collaborator

Ge Junbo

OTHER

Sponsor Role: lead

Responsible Party

Ge Junbo

Coordinating Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Dong Huang, Doctor

Role: CONTACT

huang.dong@zs-hospital.sh.cn

+8618124009136

References

Ford TJ, Stanley B, Good R, Rocchiccioli P, McEntegart M, Watkins S, Eteiba H, Shaukat A, Lindsay M, Robertson K, Hood S, McGeoch R, McDade R, Yii E, Sidik N, McCartney P, Corcoran D, Collison D, Rush C, McConnachie A, Touyz RM, Oldroyd KG, Berry C. Stratified Medical Therapy Using Invasive Coronary Function Testing in Angina: The CorMicA Trial. J Am Coll Cardiol. 2018 Dec 11;72(23 Pt A):2841-2855. doi: 10.1016/j.jacc.2018.09.006. Epub 2018 Sep 25.

Reference Type: BACKGROUND

PMID: 30266608 (View on PubMed)

Chan PS, Jones PG, Arnold SA, Spertus JA. Development and validation of a short version of the Seattle angina questionnaire. Circ Cardiovasc Qual Outcomes. 2014 Sep;7(5):640-7. doi: 10.1161/CIRCOUTCOMES.114.000967. Epub 2014 Sep 2.

Reference Type: BACKGROUND

PMID: 25185249 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32626906 (View on PubMed)

Sara JD, Widmer RJ, Matsuzawa Y, Lennon RJ, Lerman LO, Lerman A. Prevalence of Coronary Microvascular Dysfunction Among Patients With Chest Pain and Nonobstructive Coronary Artery Disease. JACC Cardiovasc Interv. 2015 Sep;8(11):1445-1453. doi: 10.1016/j.jcin.2015.06.017.

Reference Type: BACKGROUND

PMID: 26404197 (View on PubMed)

Liu L, Abdu FA, Yin G, Xu B, Mohammed AQ, Xu S, Lv X, Luo Y, Zu L, Yang C, Zhang Z, Zhou Y, Cai H, Lv Z, Xu Y, Che W. Prognostic value of myocardial perfusion imaging with D-SPECT camera in patients with ischemia and no obstructive coronary artery disease (INOCA). J Nucl Cardiol. 2021 Dec;28(6):3025-3037. doi: 10.1007/s12350-020-02252-8. Epub 2020 Sep 30.

Reference Type: BACKGROUND

PMID: 33000403 (View on PubMed)

Radico F, Zimarino M, Fulgenzi F, Ricci F, Di Nicola M, Jespersen L, Chang SM, Humphries KH, Marzilli M, De Caterina R. Determinants of long-term clinical outcomes in patients with angina but without obstructive coronary artery disease: a systematic review and meta-analysis. Eur Heart J. 2018 Jun 14;39(23):2135-2146. doi: 10.1093/eurheartj/ehy185.

Reference Type: BACKGROUND

PMID: 29688324 (View on PubMed)

Zhang D, Lv S, Song X, Yuan F, Xu F, Zhang M, Yan S, Cao X. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention: a meta-analysis. Heart. 2015 Mar;101(6):455-62. doi: 10.1136/heartjnl-2014-306578. Epub 2015 Jan 30.

Reference Type: BACKGROUND

PMID: 25637372 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37054908 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31693092 (View on PubMed)

Other Identifiers

FlashV

Identifier Type: -

Identifier Source: org_study_id