IVI-guided Versus Angiography-guided PCI in Patients With Diabetes Mellitus

Launched by NANJING FIRST HOSPITAL, NANJING MEDICAL UNIVERSITY · Apr 23, 2024

Keywords

ClinConnect Summary

The clinical trial titled "IVI-guided Versus Angiography-guided PCI in Patients With Diabetes Mellitus" is studying the best way to perform a heart procedure called percutaneous coronary intervention (PCI) in people with diabetes. This procedure is often done to open narrowed arteries and may involve placing a special type of stent (a small mesh tube) to keep the artery open. The trial will compare two methods: using intravascular ultrasound (IVUS), which provides detailed images of the arteries, versus traditional angiography, which uses X-rays. Researchers hope to find out if using IVUS can lead to better outcomes for patients with diabetes.

To participate in this trial, you need to be between 18 and 80 years old, have a confirmed diagnosis of diabetes, and require the PCI procedure due to heart-related issues. However, there are some conditions that might exclude you, such as severe heart failure or recent major surgeries. If you join the trial, you can expect to receive close monitoring and care throughout the process, helping researchers understand which guiding method is more effective for patients like you. This study aims to improve care for individuals with diabetes who need heart procedures, ultimately benefiting future patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age between 18 \~ 80 years old,
• • 2. Confirmed diabetes mellitus
• • 3. Indications for undergoing percutaneous coronary intervention using a drug-eluting stent (Invasive or quantitative fractional flow reserve (QFR or FFR) \<0.80)
• • 4. Silent angina, stable angina, unstable angina, or Non-ST-elevation myocardial infarction
• Exclusion Criteria:
• • 1. Cardiogenic shock
• • 2. Previous coronary artery bypass graft (CABG)
• • 3. Left ventricular ejection fraction \< 30%
• • 4. Requiring oral anticoagulation medications
• • 5. Any planned surgery within 12 months
• • 6. Severe chronic kidney disease defined as an estimated glomerular filtration rate (eGFR) \< 20 ml/min/1.73m2
• • 7. Platelet count \< 100,000 mm3
• • 8. Contraindication to study medications or metal
• • 9. Women of childbearing potential
• • 10. Life expectancy \< 1 year
• • 11. Any condition likely to interfere with study processes including medication compliance or follow-up visits (e.g. dementia, alcohol abuse, severe frailty, long distance to travel for follow-up visits, etc.)