NCT06269874

Study Comparing Two Administration Pathways for Adenosine During Microvascular Function Assessment

A Single-centric, ProspectivE, Randomized Controlled Study Comparing Two Administration Pathways for Adenosine During Invasive Assessment of Microvascular Function in Patients With ANOCA.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Johannes Gutenberg University Mainz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• Microvascular Coronary Artery Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	microvascular function assessment	mircovascular function parameters will be measured by administering adenosine in two different pathways

Timeline

• Start date: 2027-03-02
• Primary completion: 2027-07-31
• Completion: 2027-08-31
• First posted: 2024-02-21
• Last updated: 2024-10-08

Locations

1 site across 1 country: Germany