Clinical trial NCT05174572: IMR Evaluation in Patients with Coronary Sinus Reducer Implantation (INROAD Study)
Official title: Index of Microcirculatory Resistance Evaluation in Patients with Coronary Sinus Reducer Implantation for the Treatment of Chronic Refractory Angina Pectoris, the INROAD Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractory Angina Pectoris
Keywords: Angina
Microcirculation resistance
Coronary sinus Reducer
Lead sponsor: Consorzio Futuro in Ricerca
Sponsor class: OTHER
First posted: 2021-12-30
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The INROAD is an investigator-driven, prospective, study in which patients undergoing coronary sinus reducer implantation (Reducer) for chronic refractory angina undergo evaluation of the index of microcirculatory resistance (IMR) at the time of implantation, and at 4 months follow-up

Detailed description: Refractory angina (RA) is a chronic condition (present for at least 3 months) of moderate-severe symptoms (Canadian class Cardiovascular Society \[CCS\] II-IV) due to coronary artery disease which cannot be adequately controlled by the combination of optimal medical therapy and coronary revascularization. The clinical impact in terms of quality of life, re-hospitalization and socio-health costs is extremely negative. In this context, the therapeutic goals are primarily the management of the symptom and improvement the patient's quality of life. The unpaid therapeutic demand of these patients has brought out a large number of medical and interventional treatments, including the coronary sinus reduction system (REDUCER). Numerous clinical studies and registries have been carried out and they proved both the efficacy and safety in the use of REDUCER. The physiological mechanism that are supposed to be behind the antianginal effect of coronary sinus intervention are essentially two:

1. Redistribution of coronary flow from the subepicardium to the subendocardium.
2. Coronary neoangiogenesis In both cases, the primum movens of the Reducer's therapeutic mechanism is attributable to the increase in venous pressure due to narrowing of the coronary sinus. Nevertheless, this mechanism of action is theoretical and has never been objectively tested. The evaluation of microcirculatory resistance by IMR before and after REDUCER implantation could be the most effective way to confirm this hypothesis.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old
* Chronic refractory angina refractory to medical and interventional therapies.
* At least one open coronary artery (excluded right coronary artery) where to performs IMR evaluation
* Ability to provide informed written consent
* Life expectancy ≥1 year

Exclusion Criteria:

* Recent (within 3 months) acute coronary syndrome
* Left ventricular ejection fraction of \<30%
* Severe valvular heart disease
* Inability to perform IMR
* Technical contraindications to the implant ( A pacemaker electrode in the coronary sinus, Mean right atrial pressure \>15mmHg, Anomalous coronary sinus anatomy)

Primary outcomes:
measure: Change in IMR value
timeFrame: 4 month after Reducer implantation
Secondary outcomes:
measure: Change in angina severity according to the Seattle Angina Questionnaire
timeFrame: 4 month after Reducer implantation
measure: Change in Canadian Cardiovascular Society angina class a
timeFrame: 4 month after Reducer implantation
measure: Change in Beck depression inventory
timeFrame: 4 month after Reducer implantation
measure: Change in CFR (coronary flow reserve)
timeFrame: 4 month after Reducer implantation
measure: Change in RRR (resistive reserve ratio) value
timeFrame: 4 month after Reducer implantation
measure: Change in LVEDP (left ventricular end-diastolic pressure)
timeFrame: 4 month after Reducer implantation
measure: Change in Speckle tracking echocardiography (STE) value
timeFrame: 4 month after Reducer implantation
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Azienda Ospedaliero Universitaria di Ferrara
Study officials:
References: