I25.9
Conditions
Interventions
Group 1: Detect Ischemia is an single center, prospective observational study. All patients with clinical indication for invasive coronary angiography and intermediate coronary artery stenosis will be
Sponsors
Elisabeth Krankenhaus EssenKlinik für Kardiologie und Angiologie
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: •Age > 18 and 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.
Exclusion criteria
Exclusion criteria: • Contraindication to adenosine administration • Previous Coronary Artery Bypass surgery with patent grafts to the interrogated vessel
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) Diagnostic performance of QFR in comparison to iFR reported as positive and negative likelihood ratio Diagnostic grey zone calculation. QFR limits for achieving 95% sensitivity and specificity in comparison to iFR | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of quantitative flow Ratio (QFR) and instantaneous wave-free Ratio (iFR) with fractional flow Ratio (FFR) - Sensitivity and specificity of QFR according to FFR: Proportion of patients with positive/negative QFR and positive/negative FFR resp. (true positives/negatives) - Diagnostic performance of QFR in comparison to FFR reported as positive and negative likelihood ratio - Diagnostic grey zone calculation. QFR limits for achieving 95% sensitivity and specificity in comparison to FFR - Sensitivity and specificity of iFR according to FFR: Proportion of patients with positive/negative iFR and positive/negative FFR resp. (true positives/negatives) - Diagnostic performance of iFR in comparison to FFR reported as positive and negative likelihood ratio - Diagnostic grey zone calculation. iFR limits for achieving 95% sensitivity and specificity in comparison to FFR • Cost analysis - Cost savings of removing secondary investigations by using QFR - Cost savings of removing the need for Adenosine by using iFR. - Evaluation of costs by excess/reduced need for stenting when iFR and FFR disagree • Lesion characteristics - Influence of 3D QCA characteristics (minimum luminal area (MLA), percentage area stenosis, lesion length, minimum luminal diameter (MLD) and percentage diameter stenosis) in the prediction of iFR -FFR disagreement. - Influence of lesion location in the prediction of iFR -FFR disagreement. - Influence of p20-DAC2 score in proximal and mid-LAD stenosis in the prediction of iFR -FFR disagreement. | — |
Countries
Germany
Contacts
Public ContactChristoph Jensen
Elisabeth Krankenhaus EssenKlinik für Kardiologie und Angiologie
Outcome results
None listed