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

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ClinicalTrials.gov Identifier: NCT04465526
Recruitment Status : Recruiting
First Posted : July 10, 2020
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment
Coronary Occlusion Myocardial Ischemia Myocardial Perfusion Imaging Percutaneous Coronary Intervention Diagnostic Test: computed tomography perfusion imaging

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Study Type : Observational
Estimated 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 : February 1, 2020
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : July 1, 2022

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Intervention Details:
  • Diagnostic Test: 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.


Primary Outcome Measures :
  1. Feasibility of stress computed tomography perfusion imaging for myocardial ischemia assessment in patients with a coronary chronic total occlusion [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04465526


Locations
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Poland
National Institute of Cardiology Recruiting
Warsaw, Poland, 04-628
Contact: Maksymilian P. Opolski, MD, PhD    +48501444303    mopolski@ikard.pl   
Contact: Jacek Kwiecinski, MD, PhD    +48223434127    jkwiecinski@ikard.pl   
Sponsors and Collaborators
Institute of Cardiology, Warsaw, Poland
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Responsible Party: Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier: NCT04465526    
Other Study ID Numbers: 2.31/III/2020
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Ischemia
Coronary Occlusion
Ischemia
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease