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

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

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).

Study Overview

• Status: Completed
• Conditions: Myocardial Ischemia; Percutaneous Coronary Intervention; Coronary Occlusion; Myocardial Perfusion Imaging
• Intervention / Treatment: Diagnostic test: computed tomography perfusion imaging

• Study Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 04-628
    • National Institute of Cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: National Institute of Cardiology, Warsaw, Poland

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: July 9, 2020
• First Submitted That Met QC Criteria: July 9, 2020
• First Posted (Actual): July 10, 2020

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Myocardial Ischemia; Ischemia; Coronary Occlusion
• Other Study ID Numbers: 2.31/III/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No