CompletedNot Applicable

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

Italy21 participantsStarted 2021-12-03

Plain-language 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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Change in IMR value

Timeframe: 4 month after Reducer implantation

Trial details

NCT IDNCT05174572

SponsorConsorzio Futuro in Ricerca

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-31

View on ClinicalTrials.gov More Refractory Angina Pectoris trials