Absolute Flow for Ischemia With No Obstructive Coronary Arteries (AF-INOCA)

April 10, 2023 updated by: Fernando Alfonso, Spanish Society of Cardiology
The main objective is to prospectively validate the capacity of continuous thermodilution coronary flow reserve (CFRflow) as a predictor of the presence of angina measured by SAQ7 in patients with INOCA at 3 months. Secondary objectives include identifying hemodynamic factors related to the persistence of angina at 3 and 12 months, identifying clinical factors associated with the persistence of angina, establishing the prevalence of patients with coronary microvascular dysfunction within the cohort of INOCA patients, identifying predictors of major cardiovascular events at 12 months, validating the pathological value of MMR and establishing the pathological value of AF measured in ml/min. The study also aims to evaluate the concordance between measures of the coronary microvascular function obtained by continuous thermodilution and bolus thermodilution, as well as their concordance with clinical characteristics.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Invasive study of microvascular function has become highly relevant for the diagnosis of alterations in coronary physiology for diagnostic, prognostic, and therapeutic purposes. Currently, the microvascular resistance index (IMR) is considered the gold standard for invasive diagnosis of coronary microvascular function, with a recommendation of 2A in the current clinical practice guidelines of the European Society of Cardiology. In recent years, technical innovation has allowed for the measurement of absolute coronary flow (AF) and minimal microvascular resistance (MMR) using continuous thermodilution, enabling the determination of quantitative flow and resistance units. However, the main limitation is the absence of reference values.

Objectives:

The main objective is to prospectively validate the capacity of CFRflow as a predictor of the presence of angina measured by SAQ7 in patients with INOCA at 3 months. Secondary objectives include identifying hemodynamic factors related to the persistence of angina at 3 and 12 months, identifying clinical factors related to the persistence of angina, establishing the prevalence of patients with coronary microvascular dysfunction within the cohort of INOCA patients, identifying predictors of major cardiovascular events at 12 months, validating the pathological value of MMR and establishing the pathological value of AF measured in ml/min. The study also aims to evaluate the concordance between measures of the coronary microvascular function obtained by continuous thermodilution and bolus thermodilution, as well as their concordance with clinical characteristics.

Study Type

Observational

Enrollment (Anticipated)

121

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic De Barcelona
        • Contact:
      • Barcelona, Spain
      • Cadiz, Spain
        • Recruiting
        • Hospital Puerta del Mar
        • Contact:
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Ramón y Cajal
      • Madrid, Spain, 28006
        • Recruiting
        • Hospital Universitario de La Princesa
        • Principal Investigator:
          • Fernando RIVERO, D, PhD
    • Barcelona
      • L´Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Recruiting
        • Hospital Universitari de Bellvitge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Consecutive patients with a clinical indication for diagnostic study of coronary microvascular function due to angina without obstructive coronary lesions.

Description

Inclusion Criteria:

  • Over 18 years of age, and
  • Clinical indication for coronary angiography and in whom the use of microvascular function diagnosis by pressure guide is considered clinically necessary.
  • Clinical diagnosis of typical or atypical angina.
  • Coronary arteries without lesions or with epicardial lesions <50% by visual estimation or fractional flow reserve (FFR)>0.80.
  • Absence of clinical or anatomical contraindications for the study of microvascular function.

Consent for participation in the study prior to information and consent form signature.

Exclusion Criteria:

  • Decompensated heart failure or cardiogenic shock.
  • Admission due to Acute Coronary Syndrome with an elevation of markers in the month prior to inclusion.
  • Indication for coronary angioplasty.
  • Severe pulmonary hypertension.
  • Obstructive hypertrophic cardiomyopathy.
  • Severe valvular disease.
  • Previous allergy or intolerance to adenosine or adenosine triphosphate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Angina Status
Time Frame: At inclusion
Angina Status assessed by Seattle Angina Questionnaire (SAQ).The total score is also transformed into a scale from 0 to 100, where a higher score indicates better angina-related quality of life.
At inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life at 3 months
Time Frame: 3 months
Quality of life status in patients at 3 months post-diagnosis measured by the Seattle Angina Questionnaire (SAQ).The total score is also transformed into a scale from 0 to 100, where a higher score indicates better angina-related quality of life.
3 months
Accuracy of continuous thermodilution coronary flow reserve (CFR) measured by Youden Index = Sensitivity + Specificity - 1
Time Frame: At inclusion
Continuous thermodilution measured CFR flow and minimal microvascular resistance (MMR flow).
At inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spanish Society of Cardiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Anticipated)

April 30, 2024

Study Completion (Anticipated)

June 30, 2024

Study Registration Dates

First Submitted

March 28, 2023

First Submitted That Met QC Criteria

April 10, 2023

First Posted (Actual)

April 24, 2023

Study Record Updates

Last Update Posted (Actual)

April 24, 2023

Last Update Submitted That Met QC Criteria

April 10, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ES01100023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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