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Study Comparing Two Administration Pathways for Adenosine During Microvascular Function Assessment — ASPERA-ANOCA  

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.

Clinical Trial Summary

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

Clinical Trial Description

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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06269874
Study type Interventional
Source Johannes Gutenberg University Mainz
Contact Tommaso Gori, MD, PhD
Phone 00496131172829
Email tomgori@hotmail.com
Status Not yet recruiting
Phase N/A
Start date March 2, 2024
Completion date August 31, 2024
View Details
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