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

• Sponsor: Institute of Cardiology, Warsaw, Poland (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04465526
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Anticipated Duration (Months): 28.9
• Patients Per Site Per Month: 1

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Coronary Occlusion; Myocardial Ischemia; Myocardial Perfusion Imaging; Percutaneous Coronary Intervention	Diagnostic Test: computed tomography perfusion imaging

Study Design

• Study Type: Observational
• Anticipated Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Influence of Coronary Chronic Total Occlusion on Myocardial Perfusion on Dual-energy Computed Tomography (COPACABANA Trial)
• Actual Study Start Date: Feb 1, 2020
• Anticipated Primary Completion Date: Jul 1, 2022
• Anticipated Study Completion Date: Jul 1, 2022

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

1. 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.

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Institute of Cardiology	Warsaw		Poland	04-628

Sponsors and Collaborators

• Institute of Cardiology, Warsaw, Poland

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institute of Cardiology, Warsaw, Poland
• ClinicalTrials.gov Identifier: NCT04465526
• Other Study ID Numbers: 2.31/III/2020
• First Posted: Jul 10, 2020
• Last Update Posted: Jul 10, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Myocardial Ischemia; Coronary Occlusion; Ischemia

Study Results

No Results Posted as of Jul 10, 2020