Health Condition 1: I248- Other forms of acute ischemic heart disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age >18 years 2. Willing to participate and able to understand, read and sign the informed consent document before the planned procedure 3. Eligible for coronary angiography and/or percutaneous coronary intervention 4. Stable angina 5. Recent and stabilized NSTEMI Angiographic inclusion criteria - Coronary artery disease in two or more native major epicardial vessels or their branches by coronary angiogram with visually assessed de novo coronary stenosis in which one of the lesion has the physiological severity of the lesion is in question (typically 50-90% diameter stenosis) - All lesions are amenable to revascularization
Exclusion criteria
Exclusion criteria: - Terminal disease with life expectancy of less than 12 months - Any patient who at the time of planned angiography has ongoing ischemic symptoms - Angiography performed in the context of primary PCI of STEMI - Acute coronary syndrome with difficulty in assessing the culprit lesion - Pregnancy - Severe aortic stenosis - Significant valvular heart disease indicated for concomitant valve surgery - Cardiogenic shock or hemodynamic instability - Contraindication to adenosine - Previous CABG - Additional investigations planned for the assessment of myocardial viability. - Severe asthma Angiographic exclusion criteria - Heavily calcified or tortuous vessels that in the opinion of the investigator would result in uncrossable of pressure wire
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in treatment strategy after physiologic assessment Healthcare costs Timepoint: In-hospital and at 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| The percentage rate of concordance between FFR and RFR Procedural time Level of agreement in the decision-making strategy based on invasive angiography and physiologic assessment Functional SYNTAX score calculation based on FFR Composite of MACCE (all-cause death, documented myocardial infarction, stroke or unplanned revascularization) Rates of individual components of MACE Change in health status of patients from baselineTimepoint: IN-Hospital, 30 days and 1 year | — |
Countries
Hong Kong, India, Thailand
Contacts
BioQuest Solutions Pvt Ltd