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AzTrials

Coronary Microvascular DysfunctionAF-INOCANCT05825339

Absolute Flow for Ischemia With No Obstructive Coronary Arteries

An observational study of Coronary Microvascular Dysfunction and Coronary Microvascular Disease, run by Spanish Society of Cardiology at 6 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Coronary Flow Reserve
How many people
121 participants
Where
6 sitesSpain
Study dates
1 May 2021to 30 Jun 2024
Phase
Observational
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
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Spain6 sites, 6 recruiting

  • Hospital Clinic de Barcelona

    Barcelona, 08036

    Monica Masotti, MD, MASOTTI@clinic.cat

    Recruiting

  • Hospital del Mar

    Barcelona

    Beatriz Vaquerizo, MD, beavaquerizo@yahoo.es

    Not yet recruiting

  • Hospital Puerta del Mar

    Cadiz

    Alejandro Gutiérrez, MD, aleklos@hotmail.com

    Recruiting

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

    Rafael Romaguera, MD, rafaromaguera@gmail.com

    Recruiting

  • Hospital Universitario de La Princesa

    Madrid, 28006

    Fernando Alfonso Manterola, MD, PhD, falf@hotmail.com

    Fernando RIVERO, D, PhD

    Recruiting

  • Hospital Ramón y Cajal

    Madrid, 28034

    Rosana Hernández, MD, rhernandez_antolin@hotmail.com

    Recruiting

Other trials in Spain

About this study

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.

Read the 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.

Being tested
Coronary Flow Reserve
Keywords
Microvascular dysfunction, Coronary circulation, Myocardial ischemia Diagnosis, Coronary flow
Medical subject headings
Microvascular Angina, Angina, Stable

What participants receive

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

  • Coronary Flow ReserveDiagnostic test

    Also called Absolute Flow

    Diagnostic of Microvascular Coronary Dysfunction using continuous thermodilution flow reserve

What is being measured

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

  1. Angina Status

    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.

    Measured: At inclusion

Secondary outcomes (2)

  1. Quality of life at 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.

    Measured: 3 months

  2. Accuracy of continuous thermodilution coronary flow reserve (CFR) measured by Youden Index = Sensitivity + Specificity - 1

    Continuous thermodilution measured CFR flow and minimal microvascular resistance (MMR flow).

    Measured: At inclusion

Timeline

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

  1. First posted24 Apr 2023
  2. Study start1 May 2021
  3. Primary completion30 Apr 2024 (estimated)
  4. Study completion30 Jun 2024 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
121 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05825339
Sponsor's protocol ID
ES01100023
Acronym
AF-INOCA
Status last verified
Apr 2023
First submitted
28 Mar 2023
Last updated
24 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rivero F, Gutierrez-Barrios A, Gomez-Lara J, Fuentes-Ferrer M, Cuesta J, Keulards DCJ, Pardo-Sanz A, Bastante T, Izaga-Torralba E, Gomez-Hospital JA, Garcia-Guimaraes M, Pijls NHJ, Alfonso F. Coronary microvascular dysfunction assessed by continuous intracoronary thermodilution: A comparative study with index of microvascular resistance. Int J Cardiol. 2021 Jun 15;333:1-7. doi: 10.1016/j.ijcard.2021.03.005. Epub 2021 Mar 5.

    PubMed 33684380

  • de Vos A, Jansen TPJ, van 't Veer M, Dimitriu-Leen A, Konst RE, Elias-Smale S, Paradies V, Rodwell L, van den Oord S, Smits P, van Royen N, Pijls N, Damman P. Microvascular Resistance Reserve to Assess Microvascular Dysfunction in ANOCA Patients. JACC Cardiovasc Interv. 2023 Feb 27;16(4):470-481. doi: 10.1016/j.jcin.2022.12.012.

    PubMed 36858668

  • Gallinoro E, Bertolone DT, Fernandez-Peregrina E, Paolisso P, Bermpeis K, Esposito G, Gomez-Lopez A, Candreva A, Mileva N, Belmonte M, Mizukami T, Fournier S, Vanderheyden M, Wyffels E, Bartunek J, Sonck J, Barbato E, Collet C, De Bruyne B. Reproducibility of bolus versus continuous thermodilution for assessment of coronary microvascular function in patients with ANOCA. EuroIntervention. 2023 Jun 5;19(2):e155-e166. doi: 10.4244/EIJ-D-22-00772.

    PubMed 36809253

  • De Bruyne B, Pijls NHJ, Gallinoro E, Candreva A, Fournier S, Keulards DCJ, Sonck J, Van't Veer M, Barbato E, Bartunek J, Vanderheyden M, Wyffels E, De Vos A, El Farissi M, Tonino PAL, Muller O, Collet C, Fearon WF. Microvascular Resistance Reserve for Assessment of Coronary Microvascular Function: JACC Technology Corner. J Am Coll Cardiol. 2021 Oct 12;78(15):1541-1549. doi: 10.1016/j.jacc.2021.08.017.

    PubMed 34620412

  • Jansen TPJ, Konst RE, Elias-Smale SE, van den Oord SC, Ong P, de Vos AMJ, van de Hoef TP, Paradies V, Smits PC, van Royen N, Damman P. Assessing Microvascular Dysfunction in Angina With Unobstructed Coronary Arteries: JACC Review Topic of the Week. J Am Coll Cardiol. 2021 Oct 5;78(14):1471-1479. doi: 10.1016/j.jacc.2021.08.028.

    PubMed 34593129

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Microvascular Dysfunction and Coronary Microvascular Disease, run by Spanish Society of Cardiology at 6 sites in Spain.

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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 24 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Spain. 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?

Results are not available in the source record.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Angina Status (time frame: At inclusion). 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 NCT05825339, which also lists 5 linked publications.

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 24 Apr 2023.

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