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Study Comparing Two Administration Pathways for Adenosine During Microvascular Function Assessment

ConditionMicrovascular Coronary Artery Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohannes Gutenberg University Mainz

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • microvascular function assessment

    Diagnostic test

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Intravenous AdenosineActive comparator 1 intervention
Group B: Intracoronary AdenosineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Agreement between intravenous and intracoronary adenosine responses (IMR)

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.

Time frame
6 months

Secondary outcomes

1

Agreement between secondary parameters and reproducibility as compared with absolute

Agreement and reproducibility between secondary parameters (MRR, RRR, Pd/Pa, FFR, CFR, Ach-IMR) 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.

Time frame
6 months
2

Time required for IMR measurements

Comparison of time required for measuring IMR between intracoronary and intravenous adenosine administration

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johannes Gutenberg University Mainz

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: