Microvascular Coronary Artery Disease
Conditions
Keywords
adenosine, coronary microvascular assessment, microvascular disease
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
Interventions
DIAGNOSTIC_TESTmicrovascular function assessment
mircovascular function parameters will be measured by administering adenosine in two different pathways
Sponsors
Johannes Gutenberg University Mainz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Patients and outcome assessors will be blinded to the randomization group.
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Agreement between secondary parameters and reproducibility as compared with absolute | 6 months | 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 required for IMR measurements | 6 months | Comparison of time required for measuring IMR between intracoronary and intravenous adenosine administration |
Countries
Germany
Contacts
Primary ContactTommaso Gori, MD, PhD
Outcome results
None listed