NCT05174572

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

December 3, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 30, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2025

Completed
Last Updated

February 13, 2025

Status Verified

February 1, 2025

Enrollment Period

1.3 years

First QC Date

December 3, 2021

Last Update Submit

February 11, 2025

Conditions

Refractory Angina Pectoris

Keywords

AnginaMicrocirculation resistanceCoronary sinus Reducer

Outcome Measures

Primary Outcomes (1)

  • Change in IMR value

    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.

    4 month after Reducer implantation

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (1)

IMR

OTHER

IMR evaluation before and after Reducer implantation

Procedure: IMR

Interventions

IMRPROCEDURE

Patients undergoing coronary sinus reducer implantation (Reducer) undergo evaluation of the index of microcirculatory resistance (IMR) at the time of implantation, and at 4 months follow-up.

IMR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliero Universitaria di Ferrara

Ferrara, Ferrara, 44124, Italy

Location

Related Publications (1)

  • Tebaldi M, Campo G, Ugo F, Guarracini S, Marrone A, Clo S, Abdirashid M, Di Mauro M, Rametta F, Di Marco M, Cocco M, Marchini F, Penzo C, Erriquez A, Banai S, Biscaglia S. Coronary Sinus Narrowing Improves Coronary Microcirculation Function in Patients With Refractory Angina: A Multicenter Prospective INROAD Study. Circ Cardiovasc Interv. 2024 Jan;17(1):e013481. doi: 10.1161/CIRCINTERVENTIONS.123.013481. Epub 2024 Jan 16.

    PMID: 38227697DERIVED

MeSH Terms

Conditions

Angina Pectoris

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2021

First Posted

December 30, 2021

Study Start

December 3, 2021

Primary Completion

March 31, 2023

Study Completion

February 11, 2025

Last Updated

February 13, 2025

Record last verified: 2025-02

Locations

IT(1)