Chronic Total Occlusion of Coronary Artery
Conditions
Keywords
chronic total occlusion, coronary flow reserve
Brief summary
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
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.
Interventions
PROCEDUREpercutaneous coronary intervention
PCI of the chronic total occlusion of the coronary artery
Sponsors
University of Belgrade
Clinical Centre of Serbia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All patients with chronic total occlusion will undergo the PCI procedure of the occlusion.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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): 1. Symptoms of typical stable angina 2. Presence of inducible ischemia in the territory of the occluded artery 3. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Coronary flow reserve | six months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Coronary flow velocity reserve | six months | 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. |
| Wall Motion Score Index (WMSI) | six months | 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 |
| Change from Baseline Stable Angina questionnaire (SAQ) at 6 months | six 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) |
Countries
Serbia
Outcome results
None listed