Angina, Physiology, Biology (ANgina, FIsiologia BIOlogia)

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Epigenetic Characterization of Angina Pectoris According to the Affected Coronary Compartment: Relationship Between Invasive Physiological Coronary Evaluation and Micro-RNAs

Conditions
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Angina Pectoris

Intervention / Treatment
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* Diagnostic Test: Physiological invasive coronary evaluation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years. Patients with chest pain suggestive of angina evaluated by a cardiologist referred for diagnostic coronary angiography and possible coronary intervention. Echocardiogram ruling out noncoronary cardiac causes of chest pain. Informed consent. Exclusion Criteria: Contrast allergy not susceptible to premedication. Severe bronchial asthma or adenosine intolerance. Atrio-ventricular block (≥ 2nd degree) or acetylcholine intolerance. Acute myocardial infarction with ST-segment elevation. Acute myocardial infarction without ST-segment elevation. Cardiogenic shock. Total occlusion of any coronary artery that precludes measurements with pressure-temperature guidewires. Previous coronary artery bypass grafting. Women with the possibility of being pregnant. Renal dysfunction with an estimated glomerular filtration rate <30 mL/min/1.73m2. Inability to understand the nature of the study and / or sign informed consent. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Macrovasculature + (FFR ≤ 0.80) / Microvasculature + (IMR ≥25) | Diagnostic Test: Physiological invasive coronary evaluation<br>* Performance of FFR, IMR and acetylcholine test (Only patients in groups 3 and 4 will undergo the acetylcholine test)<br>|
| Group 2<br>Macrovasculature + (FFR ≤ 0.80) / Microvasculature - (IMR <25) | Diagnostic Test: Physiological invasive coronary evaluation<br>* Performance of FFR, IMR and acetylcholine test (Only patients in groups 3 and 4 will undergo the acetylcholine test)<br>|
| Group 3<br>Macrovasculature - (FFR>0.80) / Microvasculature + (IMR ≥25) | Diagnostic Test: Physiological invasive coronary evaluation<br>* Performance of FFR, IMR and acetylcholine test (Only patients in groups 3 and 4 will undergo the acetylcholine test)<br>|
| Group 4<br>Macrovasculature - (FFR>0.80) / Microvasculature - (IMR <25) | Diagnostic Test: Physiological invasive coronary evaluation<br>* Performance of FFR, IMR and acetylcholine test (Only patients in groups 3 and 4 will undergo the acetylcholine test)<br>|
| Group 5<br>Microvascular spasm (<90% diameter contraction, Chest pain, ECG changes) or Macrovascular spasm (>90% diameter contraction, Chest pain, ECG changes) *Only patients in groups 3 and 4 will undergo the acetylcholine test. | Diagnostic Test: Physiological invasive coronary evaluation<br>* Performance of FFR, IMR and acetylcholine test (Only patients in groups 3 and 4 will undergo the acetylcholine test)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FFR | Fractional flow reserve | Intraprocedure | 
| IMR | Index of microvascular resistance | Intraprocedure | 
| Ach | Acetilcholine test | Intraprocedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QCA | Quantitative Coronary Angiography | Intraprocedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary physiology, Biology, miRNA, Fractional flow reserve, Index of microcirculatory resistance, Angina pectoris