Absolute Flow for Ischemia With No Obstructive Coronary Arteries

Angina, Stable Clinical Trial

— AF-INOCA  

Official title:

Absolute Flow for Ischemia With No Obstructive Coronary Arteries

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05825339
• Other study ID #: ES01100023
• Status: Recruiting
• Start date: May 1, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2023
• Source: Spanish Society of Cardiology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 121
• Est. completion date: June 30, 2024
• Est. primary completion date: April 30, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Angina, Stable
• Coronary Microvascular Disease
• Coronary Microvascular Dysfunction
• Ischemia
• Microvascular Angina

Intervention

Diagnostic Test:
• Coronary Flow Reserve
Diagnostic of Microvascular Coronary Dysfunction using continuous thermodilution flow reserve

Locations

Country	Name	City	State
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Puerta del Mar	Cadiz
Spain	Hospital Universitari de Bellvitge	L´Hospitalet de Llobregat	Barcelona
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital Universitario de La Princesa	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Spanish Society of Cardiology

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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 Ass — View Citation

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 Car — View Citation

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. Reproducibilit — View Citation

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 C — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At inclusion
Secondary	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.	3 months
Secondary	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).	At inclusion