Clinical trial NCT06269874: Study Comparing Two Administration Pathways for Adenosine During Microvascular Function Assessment
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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Microvascular Coronary Artery Disease
Keywords: adenosine
coronary microvascular assessment
microvascular disease
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized 1:1 to one of the two study arms and then the following study procedures will repeated in cross-over. Randomization will be done by using a computer-generated random sequence (medcalc, mariakerke, BE).
Primary purpose: DIAGNOSTIC

Brief 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

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

Primary outcomes:
measure: Agreement between intravenous and intracoronary adenosine responses (IMR)
timeFrame: 6 months
Secondary outcomes:
measure: Agreement between secondary parameters and reproducibility as compared with absolute
timeFrame: 6 months
measure: Time required for IMR measurements
timeFrame: 6 months
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Center of Cardiology, Cardiology I, university hospital Mainz
state: Rheinland-Pfalz
Study officials:
affiliation: Center of Cardiology, Cardiology I, University Medical Center Mainz
name: Tommaso Gori, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: