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| Name | Class |
|---|---|
| Clinical Centre of Serbia | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with chronic total occlusion of the coronary artery | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| percutaneous coronary intervention | Procedure | PCI of the chronic total occlusion of the coronary artery |
|
| 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 |
| 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 |
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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):
The diameter of the occluded artery ≥2.5mm
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Branko D Beleslin, MD, PhD | University of Belgrade | Study Director |
| Miodrag C Ostojic, MD, PhD | University of Belgrade | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Centre of Serbia, University of Belgrade | Belgrade | 11000 | Serbia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22580257 | Background | Sianos G, Werner GS, Galassi AR, Papafaklis MI, Escaned J, Hildick-Smith D, Christiansen EH, Gershlick A, Carlino M, Karlas A, Konstantinidis NV, Tomasello SD, Di Mario C, Reifart N; EuroCTO Club. Recanalisation of chronic total coronary occlusions: 2012 consensus document from the EuroCTO club. EuroIntervention. 2012 May 15;8(1):139-45. doi: 10.4244/EIJV8I1A21. No abstract available. | |
| 9193021 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 28, 2017 |
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All patients with chronic total occlusion will undergo the PCI procedure of the occlusion.
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| 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 |
| Background |
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| 32693812 | Derived | Dobric M, Beleslin B, Tesic M, Djordjevic Dikic A, Stojkovic S, Giga V, Tomasevic M, Jovanovic I, Petrovic O, Rakocevic J, Boskovic N, Sobic Saranovic D, Stankovic G, Vukcevic V, Orlic D, Simic D, Nedeljkovic MA, Aleksandric S, Juricic S, Ostojic M. Prompt and consistent improvement of coronary flow velocity reserve following successful recanalization of the coronary chronic total occlusion in patients with viable myocardium. Cardiovasc Ultrasound. 2020 Jul 21;18(1):29. doi: 10.1186/s12947-020-00211-4. |
| Aug 4, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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