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

NCT06945094 | Not Yet Recruiting DMC

• 1 other identifier: FlashV
• Study Type: observational
• Target: 508
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Hemodynamics; Computational fluid dynamics; Angiography-derived IMR; coronary microvascular dysfunction; stable and unstable angina

Outcome Measures

Primary Outcomes (1)

• Patients' Seattle Angina Questionnaire (SAQ) scores

  The Seattle Angina Questionnaire (SAQ) is a rigorously validated disease-specific health status assessment tool widely used to evaluate symptoms, functional status, and quality of life in patients with coronary artery disease (CAD). Utilizing the SAQ as an endpoint in clinical trials ensures the scientific validity and comparability of study results, providing valuable insights for clinical practice.

  Before the procedure and six months post-procedure.

Secondary Outcomes (1)

• MACE (Major Adverse Cardiovascular Events)

  At 6 months, 1 year, 2 years, and 3 years post-procedure.

Study Arms (2)

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.

Device: caIMR

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.

Device: caIMR

Interventions

caIMR 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.; Grey zone patients

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

This study will enroll patients with stable angina, unstable angina, suspected myocardial ischemia, or coronary artery stenosis of less than 50%, who do not have cardiomyopathy or obstructive epicardial coronary artery disease. Specifically, we will focus on two groups: (1) patients with caIMR values between 20 and 30, and (2) patients with diffuse disease.

You may qualify if:

• Age between 18 and 80 years, regardless of gender;
• Diagnosed with stable angina, unstable angina, or suspected myocardial ischemia;
• 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.

You may not qualify if:

• Previously undergone percutaneous coronary intervention (PCI);
• History of heart failure or myocardial infarction;
• Acute myocardial infarction;
• Primary or secondary cardiomyopathy;
• Primary or secondary severe valvular heart disease;
• Severe systemic infections;
• Malignant cachectic diseases and an estimated survival of less than one year;
• Patients who are currently participating in other clinical trials involving drugs or devices and have not yet reached the primary endpoint of those trials;
• Patients whom the investigator deems to have other conditions that make them unsuitable for participation in the clinical trial.

Sponsors & Collaborators

• Ge Junbo: lead
• RainMed Medical Group: collaborator

Related Publications (9)

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  PMID: 30266608 BACKGROUND

• 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.

  PMID: 25185249 BACKGROUND

• 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.

  PMID: 32626906 BACKGROUND

• 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.

  PMID: 26404197 BACKGROUND

• 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.

  PMID: 33000403 BACKGROUND

• 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.

  PMID: 29688324 BACKGROUND

• 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.

  PMID: 25637372 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 BACKGROUND

• 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.

  PMID: 31693092 BACKGROUND

MeSH Terms

Conditions

Angina, Stable; Angina, Unstable; Myocardial Ischemia; Angina Pectoris

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dong Huang, Doctor

CONTACT

+8618124009136; huang.dong@zs-hospital.sh.cn

Study Design

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

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: April 25, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2029
• Last Updated: April 27, 2025

Record last verified: 2025-04