Absolute Flow for Ischemia With No Obstructive Coronary Arteries
NCT ID: NCT05825339
Last Updated: 2023-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
121 participants
OBSERVATIONAL
2021-05-01
2024-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Coronary Flow Reserve
Diagnostic of Microvascular Coronary Dysfunction using continuous thermodilution flow reserve
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Spanish Society of Cardiology
OTHER
Responsible Party
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Fernando Alfonso
Principal Investigator
Locations
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Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital Puerta del Mar
Cadiz, , Spain
Hospital Universitario de La Princesa
Madrid, , Spain
Hospital Ramón y Cajal
Madrid, , Spain
Countries
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Facility Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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ES01100023
Identifier Type: -
Identifier Source: org_study_id
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