Index of Microcirculatory Resistance Evaluation in Patients with Coronary Sinus Reducer Implantation for the Treatment of Chronic Refractory Angina Pectoris, the INROAD Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Refractory Angina Pectoris
- Sponsor
- Consorzio Futuro in Ricerca
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Change in IMR value
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
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)
Outcomes
Primary Outcomes
Change in IMR value
Time Frame: 4 month after Reducer implantation
Significant Change (≥ 20%) in index of microcirculatory resistance (IMR) value at 4 month follow-up as compared to baseline value (before Reducer implantation). The IMR is calculated by multiplying the distal coronary pressure by the mean transit time of a 3 ml bolus of saline at room temperature during coronary hyperaemia induced by intravenous adenosine. Normal values are usually reported as ≤25.
Secondary Outcomes
- Change in angina severity according to the Seattle Angina Questionnaire(4 month after Reducer implantation)
- Change in Canadian Cardiovascular Society angina class a(4 month after Reducer implantation)
- Change in Beck depression inventory(4 month after Reducer implantation)
- Change in CFR (coronary flow reserve)(4 month after Reducer implantation)
- Change in RRR (resistive reserve ratio) value(4 month after Reducer implantation)
- Change in LVEDP (left ventricular end-diastolic pressure)(4 month after Reducer implantation)
- Change in Speckle tracking echocardiography (STE) value(4 month after Reducer implantation)