Microvascular Coronary Artery Disease Clinical Trial
Official title:
A Single-centric, ProspectivE, Randomized Controlled Study Comparing Two Administration Pathways for Adenosine During Invasive Assessment of Microvascular Function in Patients With ANOCA.
The aim of this study is to investigate the agreement and reproducibility between intravenous and intracoronary adenosine administration during invasive assessment of microvascular function. Goals of this study are: 1. Agreement and reproducibility between intravenous and intracoronary adenosine administration in the IMR (Index of microvascular resistance) value. 2. Agreement and reproducibility of FFR(fractional flow reserve), CFR (coronary flow reserve), MRR (microvascular resistance reserve), RRR (resistive reserve ratio) and reproducibility of each of these as compared with CFRabs (absolute coronary flow). 3. Time required for IMR measurements
The study is a single-center randomized, cross-over controlled, open label trial to investigate the reproducibility and agreement between intravenous and intracoronary adenosine administration during invasive assessment of microvascular function. The primary analysis will be on the per-protocol population (i.e. including all patients who are not protocol violators). Primary endpoint: 1. Agreement and reproducibility between intravenous and intracoronary adenosine administration in the IMR value. Secondary endpoints: 1. Agreement and reproducibility of FFR, CFR, MRR, RRR and reproducibility of each of these as compared with CFRabs. 2. Time required for IMR measurements 3. Presence and severity of angina, assessed by SAQ(Seattle Angina Questionnaire)-7 4. Assessment of safety: Presence and severity of AV( atrioventricular) block, dyspnea, flush ;
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