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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-01

Study Completion Date

2022-07-01

Brief Summary

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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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Detailed Description

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Conditions

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Coronary Occlusion Myocardial Ischemia Myocardial Perfusion Imaging Percutaneous Coronary Intervention

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No