The Influence of Coronary Chronic Total Occlusion on Myocardial Perfusion on Computed Tomography

Myocardial Ischemia Clinical Trial

— COPACABANA  

Official title:

The Influence of Coronary Chronic Total Occlusion on Myocardial Perfusion on Dual-energy Computed Tomography (COPACABANA Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04465526
• Other study ID #: 2.31/III/2020
• Status: Completed
• Start date: February 1, 2020
• Est. completion date: July 1, 2022

Study information

• Verified date: December 2023
• Source: National Institute of Cardiology, Warsaw, Poland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• delivery of an informed consent and compliance with study protocol
• persistent angina pectoris (CCS class =2) refractory to optimal medical therapy
• CTO of a major coronary artery (left anterior descending artery, right coronary artery, left circumflex artery) of at least 2.5 mm vessel diameter confirmed by invasive angiography
• preserved left ventricular ejection fraction (>50%) on echocardiography or cardiac magnetic resonance with preserved contractility in the CTO territory (normokinesia and/or hypokinesia)

Exclusion Criteria:

• unstable angina and/or myocardial infarction
• prior myocardial infarction within 4 weeks before study enrolment
• occurrence of myocardial infarction and/or unplanned revascularization between the index procedure and post-procedural CTP study
• impaired renal function (eGFR =45 ml/min/m2)
• contraindications to antiplatelet therapy and/or heparin
• other contraindications to CTP (pregnancy, allergy to contrast media or pharmacologic stress agents, tachyarrhythmia, claustrophobia)

Related Conditions & MeSH terms

• Coronary Occlusion
• Ischemia
• Myocardial Ischemia
• Myocardial Perfusion Imaging
• Percutaneous Coronary Intervention

Intervention

Diagnostic Test:
• computed tomography perfusion imaging
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.

Locations

Country	Name	City	State
Poland	National Institute of Cardiology	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Cardiology, Warsaw, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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.	1 day and 3 months
Secondary	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
Secondary	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