Angina, Stable Clinical Trial
— AF-INOCAOfficial title:
Absolute Flow for Ischemia With No Obstructive Coronary Arteries
NCT number | NCT05825339 |
Other study ID # | ES01100023 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 1, 2021 |
Est. completion date | June 30, 2024 |
Verified date | April 2023 |
Source | Spanish Society of Cardiology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Recruiting |
Enrollment | 121 |
Est. completion date | June 30, 2024 |
Est. primary completion date | April 30, 2024 |
Accepts healthy volunteers | |
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Spanish Society of Cardiology |
Spain,
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
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 |
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