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

Completed

• Conditions: Myocardial Ischemia; Percutaneous Coronary Intervention; Coronary Occlusion; Myocardial Perfusion Imaging

• Registration Number: NCT04465526
• Lead Sponsor: National Institute of Cardiology, Warsaw, Poland

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-01
• Study First Submitted: 2020-07-09
• Study First Submitted QC: 2020-07-09
• Study First Posted: 2020-07-10
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-01
• Status Verified: 2023-12
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of stress computed tomography perfusion imaging for myocardial ischemia assessment in patients with a coronary chronic total occlusion	1 day	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.
Evaluation of myocardial ischemia using stress computed tomography perfusion imaging in patients with a coronary chronic total occlusion	1 day	Qualitative and quantitative assessment of myocardial ischemia using stress computed tomography perfusion imaging in patients with a coronary chronic total occlusion.

Secondary Outcome Measures

Name	Time	Method
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	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.
Radiation dose associated with computed tomography perfusion study in patients with a coronary chronic total occlusion	1 day and 3 months	Radiation dose associated with computed tomography perfusion study in patients with a coronary chronic total occlusion undergoing percutaneous recanalization attempt.
Contrast volume associated with computed tomography perfusion study in patients with a coronary chronic total occlusion	1 day and 3 months	Contrast volume associated with computed tomography perfusion study in patients with a coronary chronic total occlusion undergoing percutaneous recanalization attempt.

Trial Locations

Locations (1)

National Institute of Cardiology; 🇵🇱 Warsaw, Poland