Angina CCS Classe II-IV - IMR, RFR, FFR,CFR
Conditions
Keywords
CCS IMR, RFR, FFR,CFR
Brief summary
The aim of the present study will be to identify different phenotypes of microvascular dysfunction and their associations with the severity of anginal symptoms assessed through the Seattle Angina Questionnaire(SAQ-7).
Detailed description
After administration of unfractionated heparin (100UI/Kg), a special pressure guide (Pressure Wire X, Abbott), equipped with a distal sensor capable of measuring pressure and temperature, will be introduced inside the anterior descending branch (IVA) of the left coronary artery and hyperemia will be induced by intravenous infusion of adenosine. The IMR will be calculated using the thermodilution technique, and is given by the product between the mean distal pressure, in the left anterior descending coronary artery, and the mean transit time (Tmn) during maximal hyperemia. During the procedure, additional coronary physiological indices will be calculated such as: * Quiescent full cycle flow ratio (RFR), - Fractional flow reserve (FFR), * Coronary flow reserve (CFR) In order to identify different phenotypes of microvascular dysfunction, as follows: * Phenotype A: Patients with IMR\>25, CFR \<2 and FFR\>0.80 (concordant pure-microvascular pathological results) * Phenotype B: patients with IMR\>25, CFR\>2 and FFR\>0.80 (increased microvascular hyperemic resistance, maintenance of microvascular reactivity) * Phenotype C: Patients with IMR 25, CFR 2 and FFR\>0.80 (normal hyperemic resistance and reduced reactivity) All these phenotypes can also be combined with pathological FFR measures (\<0.80) (phenotypes A1, B1, C1).
Interventions
None listed
Sponsors
University of Catanzaro
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Università degli Studi di Ferrara
IRCCS Multimedica
Università di Siena
University of Parma
Universita di Verona
Ospedale Policlinico San Martino
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
A.O.U. Città della Salute e della Scienza
Azienda Policlinico Umberto I
Azienda Ospedaliero-Universitaria Careggi
Federico II University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Patients who meet all of the following criteria will be considered for study participation: Age ≥18 and \<85 years. Chronic coronary syndrome (including patients with anginal equivalents) Angina CCS class II-IV Evidence of inducible reversible ischemia in noninvasive trials Availability of the following measurements: * Microvascular resistance index (IMR) * Quiescent full cycle flow ratio (RFR), * fractional flow reserve (FFR), * Coronary flow reserve (CFR) Willingness to participate and sign the informed consent document prior to the procedure.
Exclusion criteria
At least one of the following: Pregnancy or breastfeeding. Medical or psychological conditions that would compromise proper and orderly participation. Left ejection fraction less than 30% Prior coronary artery bypass surgery (CABG) Decompensated congestive heart failure (CHF) Chronic or acute renal failure with creatinine \>2mg/dl Severe valve disease Patients with comorbidities limiting life expectancy to less than one year.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| (SAQ-7) | 12 months | Identify different phenotypes of microvascular dysfunction and their associations with anginal symptom severity assessed through the Seattle Angina Questionnaire (SAQ-7). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| characterization of the severity of angina | 12 months | To validate the ability of the microvascular resistance index to identify patients who have microvascular disease and its utility in characterizing angina severity. Identify different phenotypes of microvascular dysfunction and their associations with comorbidities, cardiovascular risk factors, and drug therapy. A sub-analysis on the use of different antianginal drugs will be performed to better understand the impact of pharmacotherapy on different microvascular dysfunction phenotypes. Evaluate the health status of patients in different microvascular dysfunction phenotypes through the EQ-5D-5L questionnaire. EQ-5D is a standardized measure of health status developed by the EuroQoL Group in order to provide a simple and generic measure of health for clinical and economic evaluation. Evaluate the state of depression induced by the disease through The Brief Illness Perception Questionnaire (B-IPQ). |
Countries
Italy
Outcome results
None listed