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

Launched by GE JUNBO · Apr 18, 2025

Keywords

ClinConnect Summary

This clinical trial, called Flash V, is exploring a new way to assess a condition known as Coronary Microvascular Dysfunction (CMD), which can cause chest pain (angina) and other heart-related issues. The researchers want to see how well a specific test, called the coronary angiography-derived index of microcirculatory resistance (caIMR), can help determine if patients with certain types of angina have this dysfunction. They will focus on two groups: patients with caIMR values between 20 and 30, and those with more widespread heart disease. Over three years, they will track how participants feel and their overall health outcomes using a questionnaire about their angina symptoms.

To participate in the trial, you need to be between 18 and 80 years old and have been diagnosed with stable or unstable angina, or suspected myocardial ischemia. You must also have a specific type of heart blood vessel narrowing (less than 50%) and certain caIMR values. However, there are some exclusions, such as if you've had heart surgery or a heart attack in the past. If you join this trial, you'll be helping researchers understand more about CMD, which could lead to better treatments for patients like you in the future.

Gender

ALL

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.