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Not yet recruiting NCT06269874

Study Comparing Two Administration Pathways for Adenosine During Microvascular Function Assessment

No phase Interventional Microvascular Coronary Artery Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: microvascular function assessment.
Who it may be relevant to
Registry conditions: Microvascular Coronary Artery Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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.

Overview

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

Interventions

  • Diagnostic test microvascular function assessment
    mircovascular function parameters will be measured by administering adenosine in two different pathways

Primary outcome measures

  • Agreement between intravenous and intracoronary adenosine responses (IMR) [Time frame: 6 months]
Secondary outcome measures (2)
  • Agreement between secondary parameters and reproducibility as compared with absolute [Time frame: 6 months]
  • Time required for IMR measurements [Time frame: 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Diagnostic

Study locations

Germany · 1 center
  • Center of Cardiology, Cardiology I, university hospital Mainz — Mainz

Identifiers

NCT: NCT06269874 · ASPERA-ANOCA · 20240124

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗