IMR Evaluation in Patients with Coronary Sinus Reducer Implantation (INROAD Study)

Consorzio Futuro in Ricerca

Status: Completed

Conditions: Refractory Angina Pectoris

Treatments: Procedure: IMR

Study type: Interventional

Funder types: Other

Identifiers

NCT05174572

2021

Details and patient eligibility

About

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

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

IMR

Other group

Description:

IMR evaluation before and after Reducer implantation

Treatment:

Procedure: IMR