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Refractory Angina PectorisINROADNCT05174572

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

A study testing IMR in people with Refractory Angina Pectoris, run by Consorzio Futuro in Ricerca at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Refractory Angina Pectoris
What is being tested?
IMR
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteItaly
Study dates
3 Dec 2021to 11 Feb 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Italy1 site

  • Azienda Ospedaliero Universitaria di Ferrara

    Ferrara, Ferrara, 44124

Other trials in Italy

About this 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

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

Read the 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.
Being tested
IMR
Keywords
Angina, Microcirculation resistance, Coronary sinus Reducer
Medical subject headings
Angina Pectoris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IMRProcedure or surgery

    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.

Study groups in NCT05174572
Study groupRoleWhat they receive
IMROtherIMR evaluation before and after Reducer implantation
Receives: Procedure: IMR

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 4 month after Reducer implantation

Secondary outcomes (7)

  1. Change in angina severity according to the Seattle Angina Questionnaire

    Change in angina severity according to the Seattle Angina Questionnaire (SAQ) after Reducer implantation. The questionnaire is performed before the Reducer implantation and after 4 months. The scores on the SAQ angina frequency scale of 0-30 points indicate daily angina, 31-60 points indicate weekly angina, 61-99 points indicate monthly angina, and 100 points indicate no angina. Zero at SAQ indicate a worst clinical situation.

    Measured: 4 month after Reducer implantation

  2. Change in Canadian Cardiovascular Society angina class a

    Change in Canadian Cardiovascular Society (CCS) angina class by two or more classes after Reducer implantation. The CCS evaluation is performed before the Reducer implantation and after 4 months. A CCS angina class I: ordinary activity such as walking or climbing stairs does not precipitate angina. CCS II : angina precipitated by emnotion, cold weather or meals and by walking up stairs-. CCS III: marked limitation of ordinary physical activity. CCS III indicate a worst clinical situation.

    Measured: 4 month after Reducer implantation

  3. Change in Beck depression inventory

    Change in Beck depression inventory (BDI) scale after Reducer Implantation. The questionnaire is performed before the Reducer implantation and after 4 months. A BDI scores from 0 through 9 indicate no or minimal depression; scores from 10 through 18 indicate mild to moderate depression; scores from 19 through 29 indicate moderate to severe depression; and scores from 30 through 63 indicate severe depression.A BDI of 63 indicate a worst clinical situation.

    Measured: 4 month after Reducer implantation

  4. Change in CFR (coronary flow reserve)

    Change in CFR (coronary flow reserve) value after Reducer Implantation. The CFR is performed before the Reducer implantation and after 4 month. CFR is defined as hyperemic coronary flow divided by resting flow and can be measured invasively in the catheterization laboratory with a cut-off of normality ≥ 2.0.

    Measured: 4 month after Reducer implantation

  5. Change in RRR (resistive reserve ratio) value

    Change in RRR (resistive reserve ratio) value after Reducer implantation. The RRR is performed before Reducer implantation and after 4 month. RRR was calculated as the ratio between resting and hyperemic distal coronary pressure ([resting Tmn/hyperemic Tmn] × [resting Pd/ hyperemic Pd]); which can therefore be simplified as the relationship between CFR x [resting Pd/ hyperemic Pd]. Cut-off values of normality is > 3.5.

    Measured: 4 month after Reducer implantation

  6. Change in LVEDP (left ventricular end-diastolic pressure)

    Change in LVEDP (left ventricular end-diastolic pressure) after Reducer implantation. LVEDP is performed before Reducer implantation and after 4 month. The LVEDP is measure 50 ms after the beginning of the QRS complex, usually coinciding with the R wave. The normal LVEDP cut-off is 15 mmHg.

    Measured: 4 month after Reducer implantation

  7. Change in Speckle tracking echocardiography (STE) value

    Change in Speckle tracking echocardiography (STE) value after Reducer implantation

    Measured: 4 month after Reducer implantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2021
  2. Study start3 Dec 2021
  3. Primary completion31 Mar 2023
  4. Study completion11 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05174572
Sponsor's protocol ID
2021
Acronym
INROAD
Status last verified
Feb 2025
First submitted
3 Dec 2021
Last updated
13 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 38227697

Questions about this trial

What is this clinical trial studying?

A study testing IMR in people with Refractory Angina Pectoris, run by Consorzio Futuro in Ricerca at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in IMR value (time frame: 4 month after Reducer implantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05174572, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.

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