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The COPACABANA study is designed as a single-centre, open, prospective trial aimed to assess the influence of coronary chronic total occlusion (CTO) on downstream myocardial ischemia via the novel computed tomography perfusion (CTP) imaging technique. To this end, consecutive patients with CTO of a major coronary artery scheduled to undergo percutaneous recanalization of occluded coronary artery based on clinical grounds, will undergo stress CTP using state-of-the-art dual-energy CT scanner at 2 time points (before and 3 months after successful restoration of flow in the CTO vessel).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| computed tomography perfusion imaging | Diagnostic Test | The new-generation dual-source computed tomography scanner Somatom® Force will be used for all CTP studies. Myocardial perfusion will be evaluated in a stress dynamic CT protocol. The scan range will be determined based on a low-dose non-contrast scan. Subsequently, regadenoson will be administered intravenously at a single dose of 0.4 mg, and followed after 50 seconds delay by 35 mL of the iodinated contrast agent (iohexol, concentration 350 mg I/mL) injected at the flow rate of 5 mL/s. Finally, low-dose non-contrast dual-energy CT scan will be performed 5-6 min after the dynamic scan to assess late enhancement of the myocardium. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of stress computed tomography perfusion imaging for myocardial ischemia assessment in patients with a coronary chronic total occlusion | Feasibility of a fast, reliable and safe evaluation of myocardial ischemia in patients with CTO using state-of-the-art computed tomography scanner (SOMATOM® Force) with a dual-energy stress myocardial perfusion imaging protocol in order to obtain in-depth knowledge of the underlying conditions and characteristics of this phenomenon. | 1 day |
| Evaluation of myocardial ischemia using stress computed tomography perfusion imaging in patients with a coronary chronic total occlusion | Qualitative and quantitative assessment of myocardial ischemia using stress computed tomography perfusion imaging in patients with a coronary chronic total occlusion. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Change in myocardial perfusion between baseline (pre-procedural) and follow-up (post-procedural) stress computed tomography perfusion study after successful recanalization of the chronically occluded coronary artery | Qualitative and quantitative assessment of the change in myocardial perfusion between baseline (pre-procedural) and follow-up (post-procedural) stress computed tomography perfusion study after successful recanalization of the chronically occluded coronary artery. |
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Inclusion Criteria:
Exclusion Criteria:
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We intend to include 30 consecutive patients with chronic total occlusion of a major coronary artery and preserved left ventricular ejection fraction (>50%) referred for percutaneous recanalization attempt based on clinical grounds.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Cardiology | Warsaw | 04-628 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37400307 | Derived | Kwiecinski J, Oleksiak A, Kruk M, Zysk A, Debski A, Knaapen P, Schumacher SP, Barbero U, Witkowski A, Kepka C, Opolski MP. Computed tomography perfusion and angiography in patients with chronic total occlusion undergoing percutaneous coronary intervention. Atherosclerosis. 2023 Sep;381:117174. doi: 10.1016/j.atherosclerosis.2023.06.080. Epub 2023 Jun 25. |
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| 1 day and 3 months |
| Radiation dose associated with computed tomography perfusion study in patients with a coronary chronic total occlusion | Radiation dose associated with computed tomography perfusion study in patients with a coronary chronic total occlusion undergoing percutaneous recanalization attempt. | 1 day and 3 months |
| Contrast volume associated with computed tomography perfusion study in patients with a coronary chronic total occlusion | Contrast volume associated with computed tomography perfusion study in patients with a coronary chronic total occlusion undergoing percutaneous recanalization attempt. | 1 day and 3 months |
| ID | Term |
|---|---|
| D054059 | Coronary Occlusion |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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