Angina, Physiology, Biology (ANgina, FIsiologia BIOlogia)

Hospital Arnau de Vilanova100 enrolled

Overview

Relationship between invasive physiological assessment with FFR and IMR and biological markers as micro-RNA's according to coronary vascular compartiment affected (Group 1: Macrovasculature + / Microvasculature +; Group 2: Macrovasculature + / Microvasculature -; Group 3: Macrovasculature - / Microvasculature +; Group 4: Macrovasculature - / Microvasculature -). Also, biological markers will be related with presence of microvascular spasm or macrovascular spasm (Group 5).

Patients with chest pain suggestive of angina after ruling out other cardiac and non-cardiac causes, referred for invasive coronary angiography, will be evaluated by coronary angiography and invasive coronary physiological assessment by determining FFR and IMR and by performing a vasoreactivity test with acetylcholine. A relationship will be established between the invasive physiological assessment with FFR and IMR and biological markers such as micro-RNA's according to the affected coronary vascular compartment (Group 1: Macrovasculature + / Microvasculature +; Group 2: Macrovasculature + / Microvasculature -; Group 3 : Macrovasculature - / Microvasculature +; Group 4: Macrovasculature - / Microvasculature -). In addition, the biological markers will be related to the presence of microvascular spasm or macrovascular spasm (Group 5). Finally, among other biological markers, the following miRNAs will be compared. These miRNA's present consistent data in the literature about their over or underexpression.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Angina Pectoris

Interventions

Physiological invasive coronary evaluationDIAGNOSTIC_TEST

Performance of FFR, IMR and acetylcholine test (Only patients in groups 3 and 4 will undergo the acetylcholine test)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥ 18 years. 2. Patients with chest pain suggestive of angina evaluated by a cardiologist referred for diagnostic coronary angiography and possible coronary intervention. 3. Echocardiogram ruling out noncoronary cardiac causes of chest pain. 4. Informed consent. Exclusion Criteria: 1. Contrast allergy not susceptible to premedication. 2. Severe bronchial asthma or adenosine intolerance. 3. Atrio-ventricular block (≥ 2nd degree) or acetylcholine intolerance. 4. Acute myocardial infarction with ST-segment elevation. 5. Acute myocardial infarction without ST-segment elevation. 6. Cardiogenic shock. 7. Total occlusion of any coronary artery that precludes measurements with pressure-temperature guidewires. 8. Previous coronary artery bypass grafting. 9. Women with the possibility of being pregnant. 10. Renal dysfunction with an estimated glomerular filtration rate \<30 mL/min/1.73m2. 11. Inability to understand the nature of the study and / or sign informed consent. 12. Any other medical condition that, in the opinion of the researcher, may lead to safety issues for patients or may alter the results of the study.

Locations (1)

Hospital Arnau de Vilanova

Lleida, Catalonia, Spain

RECRUITING

Outcomes

Primary Outcomes

FFR

Fractional flow reserve

Time frame: Intraprocedure

IMR

Index of microvascular resistance

Time frame: Intraprocedure

Ach

Acetilcholine test

Time frame: Intraprocedure

Secondary Outcomes

QCA

Quantitative Coronary Angiography

Time frame: Intraprocedure

Central Contacts

Diego Fernández-Rodriguez, MD, PhD

CONTACT

+34-651369729 dfernandez.lleida.ics@gencat.cat

Data from ClinicalTrials.gov

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