Comparing IVUS-guided and angiography-guided PCI in diabetic patients
Intravascular Imaging-guided Versus Angiography-guided PCI in Patients With Diabetes Mellitus: the Muticenter, Randomized, Prospective IVI-DIABETES Trial
NA · Nanjing First Hospital, Nanjing Medical University · NCT06380868
This study is testing whether using special imaging during heart procedures can help diabetic patients have better outcomes compared to the usual method.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1332 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Nanjing First Hospital, Nanjing Medical University (other) |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06380868 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of intravascular imaging-guided percutaneous coronary intervention (PCI) compared to traditional angiography-guided PCI in patients with diabetes mellitus. It aims to determine whether IVUS-guided procedures lead to better clinical outcomes, specifically targeting vessel failure, cardiac death, and myocardial infarction. The study will involve patients aged 18 to 80 who require PCI with drug-eluting stents and will exclude those with severe comorbidities. The findings could provide valuable insights into optimizing PCI techniques for diabetic patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with confirmed diabetes mellitus who require PCI.
Not a fit: Patients with severe comorbidities or contraindications to the study procedures will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved clinical outcomes for diabetic patients undergoing PCI.
How similar studies have performed: Previous studies have shown promising results for IVUS-guided procedures, but this specific comparison in diabetic patients is novel.
Eligibility criteria
Show full inclusion / exclusion 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.)
Where this trial is running
Nanjing, Jiangsu
- Nanjing First Hospital — Nanjing, Jiangsu, China (RECRUITING)
Study contacts
- Principal investigator: Jing Kan, MD — Nanjing First Hospital, Nanjing Medical University, and Shan'Xi Provincial People's Hospital, China
- Study coordinator: Shao-Liang C Chen, MD
- Email: chmengx@126.com
- Phone: 13605157029
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetes