Health Condition 1: I200- Unstable angina
Conditions
Interventions
None listed
Sponsors
Ananthapuri Hospitals and Research Institute
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diabetes inclusion criteria a. Previously diagnosed and currently on diabetes medication b. Patient having any one of the below as per American Diabetes Association criteria (HbA1c =6.5% or Fasting plasma glucose =126 mg/dL (7.0 mmol/L) or 2-hour glucose =200 mg/dL (11.1mmol/L)) 2. Patients of either gender, aged = 18 years 3. DM patients with single or multivessel lesions in native vessels, undergoing PCI and suitable for invasive cardiovascular diagnostic procedures, FFR and OCT 4. Patients with Unstable Angina, stable ischemic heart disease, or NSTEMI 5. Willing to provide inform consent to share the data
Exclusion criteria
Exclusion criteria: 1. Patients unwilling to sign the informed consent 2. Hemodynamic instability or cardiogenic shock patients 3. Patients who have a life expectancy of less than 12 months 4. Contraindication for dual antiplatelet therapy (DAPT) 5. Patients with Chronic Total Occlusion lesions, Aorto-Ostial lesions 6. Prior CABG patients 7. Lesions with in-stent restenosis 8. Left Main disease patients 9. Patients with GFR 10. Patients with KILLIP class III or IV 11. Patients with STEMI 12. Distal coronary lesions where OCT or FFR study may be difficult to perform 13. Patients as per the discretion of treating physician, lesions where FFR and/or OCT cannot be performed due to technical reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To study the clinical outcomes of an OCT and FFR guided PCI strategy in patients with diabetes mellitus with respect to target lesion failure at 12 months compared against a clinical acceptance criterion of (12.5% based on historical event rates in patients with diabetes mellitus receiving DES)Timepoint: 12 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Procedural efficiency including Procedure time and Contrast Volume 2. Rate of concordance and discordance between FFR and RFR 3. stent thrombosis 4. Association of RFR/FFR concordance and discordance with plaque characteristics Timepoint: 1. Baseline 2. Baseline 3. 12 months 4. Baseline | — |
Countries
Bangladesh, India
Contacts
Public ContactDr C G Bahuleyan
Ananthapuri Hospitals and Research Institute
Outcome results
None listed