Clinical trial NCT04465526: The Influence of Coronary Chronic Total Occlusion on Myocardial Perfusion on Computed Tomography
Official title: The Influence of Coronary Chronic Total Occlusion on Myocardial Perfusion on Dual-energy Computed Tomography (COPACABANA Trial)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Occlusion
Myocardial Ischemia
Myocardial Perfusion Imaging
Percutaneous Coronary Intervention
Lead sponsor: National Institute of Cardiology, Warsaw, Poland
Sponsor class: OTHER
First posted: 2020-07-10
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).


Eligibility criteria: 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)

Primary outcomes:
measure: Feasibility of stress computed tomography perfusion imaging for myocardial ischemia assessment in patients with a coronary chronic total occlusion
timeFrame: 1 day
measure: Evaluation of myocardial ischemia using stress computed tomography perfusion imaging in patients with a coronary chronic total occlusion
timeFrame: 1 day
Secondary outcomes:
measure: 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
timeFrame: 1 day and 3 months
measure: Radiation dose associated with computed tomography perfusion study in patients with a coronary chronic total occlusion
timeFrame: 1 day and 3 months
measure: Contrast volume associated with computed tomography perfusion study in patients with a coronary chronic total occlusion
timeFrame: 1 day and 3 months
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: National Institute of Cardiology
Study officials:
References: