Evaluation of the Impact of Fractional flow reserve and Optical Coherence Tomography on the Outcomes of Percutaneous coronary intervention in Diabetic Patients
- Conditions
- Health Condition 1: I200- Unstable angina
- Registration Number
- CTRI/2021/09/036375
- Lead Sponsor
- Ananthapuri Hospitals and Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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 < 30 ml/min
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 1. Procedural efficiency including Procedure time and Contrast Volume <br/ ><br>2. Rate of concordance and discordance between FFR and RFR <br/ ><br>3. stent thrombosis <br/ ><br>4. Association of RFR/FFR concordance and discordance with plaque characteristics <br/ ><br>Timepoint: 1. Baseline <br/ ><br>2. Baseline <br/ ><br>3. 12 months <br/ ><br>4. Baseline