TO assess the Safety and feasibility of OCT -Optical Coherence Tomography (medical imaging technique) guided zero contrast PCI (Percutaneous Coronary Intervention) using non contrast flush media in patients at risk of Contrast Induced-Acute Kidney Injury.
Not Applicable
- Conditions
- Health Condition 1: - Health Condition 2: I220- Subsequent ST elevation (STEMI) myocardial infarction of anterior wall
- Registration Number
- CTRI/2019/07/020154
- Lead Sponsor
- Institute of cardiovascular diseases
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patients who will be undergoing PCI for chronic stable angina or acute coronary syndrome (ACS) â?? unstable angina (UA)/ non ST-elevation myocardial infarction (NSTEMI), with at least one of the following risk factors for CI-AKI.
Age > 18 years
Diabetic or hypertensive nephropathy
eGFR < 60ml/min/1.73m2
Functionally single kidney
Previous renal transplantation
Haemoglobin < 10g/dL
Recent decompensated heart failure within one month
Left ventricular ejection fraction < 45%
Systolic blood pressure < 100mmHg
Exclusion Criteria
Complex type C lesions
Chronic total occlusion
Planned double stent strategy for bifurcation lesion
Lesions requiring rotational atherectomy
Cardiogenic shock
STEMI patients who will be undergoing Primary PCI
Stent thrombosis
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Successful completion of PCI without contrast and absence of geographic miss, coronary artery perforation or coronary artery dissection and TIMI III flow in the final check angiogram. <br/ ><br>Timepoint: Successful completion of PCI without contrast and absence of geographic miss, coronary artery perforation or coronary artery dissection and TIMI III flow in the final check angiogram.
- Secondary Outcome Measures
Name Time Method 1)Composite of major adverse cardio cerebro vascular events at one month follow up namely death, myocardial infarction (MI), repeat revasculariisation and stroke. <br/ ><br>2) Death at one month followup <br/ ><br>3) MI at one month followup <br/ ><br>4) Repeat revascularisation at one month followup <br/ ><br>5) Stroke at one month followup <br/ ><br>6) percent change in eGFR at one month followup <br/ ><br>7) Need for renal replacement therapy (RRT) at one month followupTimepoint: 1)Composite of major adverse cardio cerebro vascular events at one month follow up namely death, myocardial infarction (MI), repeat revasculariisation and stroke. <br/ ><br>2) Death at one month followup <br/ ><br>3) MI at one month followup <br/ ><br>4) Repeat revascularisation at one month followup <br/ ><br>5) Stroke at one month followup <br/ ><br>6) percent change in eGFR at one month followup <br/ ><br>7) Need for renal replacement therapy (RRT) at one month followup