Properties of Myocardial Microcirculation in Patients With Different Pathomorphological Substrates, Before and After Recanalization of Coronary Artery CTO

Study Overview
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Brief Summary
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This study will evaluate the changes in myocardial microcirculatory parameters of the collateral donor artery after recanalization of coronary artery chronic total occlusion.

Detailed Description
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This study will include patients with chronic total occlusion (CTO) of one coronary artery who will undergo the recanalization of the CTO. Before the procedure, myocardial viability, ischemia, functional parameters of the collateral donor blood vessels, echocardiography, and quality of life will be assessed. After the recanalization, these parameters will be assessed again 24h and 6 months after the procedure.

Official Title
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Properties of Myocardial Microcirculation in Patients With Different Pathomorphological Substrates, Before and After Recanalization of Coronary Artery Chronic Total Occlusion

Conditions
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Chronic Total Occlusion of Coronary Artery

Intervention / Treatment
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* Procedure: percutaneous coronary intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over the age of 18 with signed informed consent to participate in the study Presence of one CTO on native coronary arteries (with TIMI 0 flow) Presence of clinical indication for attempting a PCI for CTO (at least one of the criteria present): Symptoms of typical stable angina Presence of inducible ischemia in the territory of the occluded artery Presence of viable myocardium in the territory of the occluded artery The diameter of the occluded artery ≥2.5mm Exclusion Criteria: Acute coronary syndrome in the past month Existing contraindication for administration of dual antiplatelet therapy in the duration of 12 months Contraindications for implanting the drug-eluting stents Existence of 2 or more CTOs on native coronary arteries (with TIMI 0 flow) Severe tortuosity or calcifications of the coronary arteries Left ventricle aneurysm Previous coronary artery bay-pass graft or any other cardiac surgery Previous myocardial infarction in the coronary artery territory different from the CTO Ejection fraction of the left ventricle less than 30% Permanent atrial fibrillation Pregnancy Patients with known allergy to iodine contrast that cannot be controlled with medication Patients who are unable or unwilling to cooperate and come for check-up visits Life expectancy less than a year Hemorrhagic diathesis, coagulopathy, or rejection of blood transfusion

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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All patients with chronic total occlusion will undergo the PCI procedure of the occlusion.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with chronic total occlusion of the coronary artery<br>In each patient before the PCI procedure, the investigators will assess myocardial viability, functional parameters of collateral blood vessels, and quality of life. 24h and 6 months after the procedure these parameters will be reevaluated as well as functional parameters of the treated coronary artery. | Procedure: percutaneous coronary intervention<br>* PCI of the chronic total occlusion of the coronary artery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronary flow reserve | Change in coronary flow reserve of the collateral donor vessel (after PCI as compared to values before PCI) will be regarded as primary outcome measure | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronary flow velocity reserve | Correlation of coronary flow velocity reserve change of the collateral donor vessel (after PCI as compared to values before PCI) with viability measured by the percentage of viable myocardium on Single Photon Emission Computed Tomography (SPECT) of myocardial perfusion. | six months | 
| Wall Motion Score Index (WMSI) | Relation of coronary flow velocity reserve change with wall motion score index on stres-echocardyography test where the wall motion segment abnormalities will be graded as such: 1 - normokinesis, 2 - hypokinesis, 3- akinesis and 4 dyskinesis, and the higher values indicates worse outcome | six months | 
| Change from Baseline Stable Angina questionnaire (SAQ) at 6 months | Relation of coronary flow velocity reserve change with the quality of life measured by 19-item Seattle Angina Questionnaire that assesses angina frequency (with 9 questions where answers range from 1 to 6, the total score ranges from 0 to 100, where the higher value indicates better outcome), angina stability ( with 1 question where answers range from 1 to 6, the total score ranges from 0 to 100, where the higher value indicates better outcome), the angina frequency scale (with 2 questions where answers range from 1 to 5, the total score ranges from 0 to 100, where the higher value indicates better outcome), treatment satisfaction (with 4 questions where answers range from 1 to 6, the total score ranges from 0 to 100, where the higher value indicates better outcome), and disease perception/QoL (with 3 questions where answers range from 1 to 5, the total score ranges from 0 to 100, where the higher value indicates better outcome) | six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic total occlusion, coronary flow reserve