Absolute Flow for Ischemia With No Obstructive Coronary Arteries

NCT05825339 | Unknown DMC

• 1 other identifier: ES01100023
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Coronary Microvascular Dysfunction; Coronary Microvascular Disease; Angina, Stable

Keywords

Microvascular dysfunction; Coronary circulation; Myocardial ischemia Diagnosis; Coronary flow

Outcome Measures

Primary Outcomes (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.

  At inclusion

Secondary Outcomes (2)

• Quality of life at 3 months

  3 months

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

  At inclusion

Interventions

Coronary Flow Reserve DIAGNOSTIC_TEST

Diagnostic of Microvascular Coronary Dysfunction using continuous thermodilution flow reserve

Also known as: Absolute Flow

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Decompensated heart failure or cardiogenic shock.
• Indication for coronary angioplasty.
• Severe pulmonary hypertension.
• Obstructive hypertrophic cardiomyopathy.
• Severe valvular disease.
• Previous allergy or intolerance to adenosine or adenosine triphosphate.

Sponsors & Collaborators

• Spanish Society of Cardiology: lead

Study Sites (6)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

RECRUITING

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

RECRUITING

Hospital del Mar

Barcelona, Spain

NOT YET RECRUITING

Hospital Puerta del Mar

Cadiz, Spain

RECRUITING

Hospital Universitario de La Princesa

Madrid, 28006, Spain

RECRUITING

Hospital Ramón y Cajal

Madrid, 28034, Spain

RECRUITING

Related Publications (5)

• 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.

  PMID: 33684380 BACKGROUND

• 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.

  PMID: 36858668 RESULT

• 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.

  PMID: 36809253 RESULT

• 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.

  PMID: 34620412 RESULT

• 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.

  PMID: 34593129 RESULT

MeSH Terms

Conditions

Microvascular Angina; Angina, Stable

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 24, 2023
• Study Start: May 1, 2021
• Primary Completion: April 30, 2024
• Study Completion: June 30, 2024
• Last Updated: April 24, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (6)