Study Comparing Two Administration Pathways for Adenosine During Microvascular Function Assessment

NCT06269874 · tracked via the Priya Life Science Germany tracker

Sponsor

Johannes Gutenberg University Mainz

Phase

Not applicable

Started

2027-03-02

Last updated

2024-10-08

Condition(s) studied

Microvascular Coronary Artery Disease

Investigational drug(s) / intervention(s)

microvascular function assessment

microvascular function assessment: mircovascular function parameters will be measured by administering adenosine in two different pathways

Study 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

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Chronic coronary syndrome (including patients with anginal equivalents). * Indication to cardiac catheterization; * Indication to the assessment of microvascular function (note: patients will be asked for participation and consented prior to the first measurement of microvascular function, which will be conducted as per clinical indication) * Willingness to participate and ability to understand, read and sign the informed consent * Age\>18 years Exclusion Criteria: * Age \<18 years * Bronchial asthma, COPD (chronic obstructive pulmonary disease) * Secondary or tertiary atrioventricular block without prior pacemaker implantation * Previous CABG (coronary artery bypass graft) with patent grafts to the left anterior descending coronary * Epicardial coronary disease (FFR \<0.80 with evidence of a focal stenosis) in the left anterior descending territory * Inability to provide informed consent

Primary outcome measure(s)

Agreement between intravenous and intracoronary adenosine responses (IMR) — 6 months
Agreement and reproducibility between IMR (index of microvascular resistance) obtained with intravenous and intracoronary adenosine administration during invasive assessment of microvascular function as assessed by Cohen´s Kappa, intraclass correlation coefficient and Bland-Altman analysis.

Trial sites (1)

Facility	City	Region	Status
Center of Cardiology, Cardiology I, university hospital Mainz	Mainz	Rhineland-Palatinate

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06269874 on ClinicalTrials.gov ↗ ← All trials in Germany