DETErmining the funCTional significance of Intermediate Stenoses in isCHEMIc heArt disease: Diagnostic agreement of iFR and QFR.
- Conditions
- I25.9Chronic ischaemic heart disease, unspecified
- Registration Number
- DRKS00012757
- Lead Sponsor
- Elisabeth Krankenhaus EssenKlinik für Kardiologie und Angiologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 280
•Age > 18 and < 90 years of age with symptoms of myocardial ischemia and angina or angina equivalent (chest pain, abnormal stress testing, abnormal noninvasive testing)
•Patients witch semi recent ( >3 days) acute coronary syndromes can be included but only for the non-culprit vessels and outside of primary intervention during acute myocardial infarction.
•Willing to participate and able to understand, read and sign the informed consent document before the planned procedure
•Eligible for coronary angiography and/or percutaneous coronary intervention
•Coronary artery disease with at least 1 or more visually assessed de novo coronary stenosis (30-90% diameter stenosis) in native major epicardial vessel or its branches by coronary angiogram.
•Contraindication to adenosine administration
•Previous Coronary Artery Bypass surgery with patent grafts to the interrogated vessel
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sensitivity and specificity of quantitative flow Ratio (QFR) according to instantaneous wave-free Ratio (iFR): Proportion of patients with positive/negative QFR and positive/negative iFR resp. (true positives/negatives) <br><br>Diagnostic performance of QFR in comparison to iFR reported as positive and negative likelihood ratio <br><br>Diagnostic grey zone calculation. QFR limits for achieving 95% sensitivity and specificity in comparison to iFR<br>
- Secondary Outcome Measures
Name Time Method