Coronary OcclusionCOPACABANANCT04465526
The Influence of Coronary Chronic Total Occlusion on Myocardial Perfusion on Computed Tomography
An observational study of Coronary Occlusion and Myocardial Ischemia, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Occlusion, Myocardial Ischemia, Myocardial Perfusion Imaging
- What is being tested?
- computed tomography perfusion imaging
- Type of treatment
- Injection or infusion
- How many people
- 27 participants
- Where
- 1 sitePoland
- Study dates
- 1 Feb 2020to 1 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Coronary Occlusion, Myocardial Ischemia, Myocardial Perfusion Imaging, Percutaneous Coronary Intervention
- Being tested
- computed tomography perfusion imaging
- Medical subject headings
- Coronary Occlusion, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computed tomography perfusion imagingDiagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 day
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 1 day and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start1 Feb 2020
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary OcclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04465526
- Sponsor's protocol ID
- 2.31/III/2020
- Acronym
- COPACABANA
- Status last verified
- Dec 2023
- First submitted
- 9 Jul 2020
- Last updated
- 16 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kwiecinski J, Oleksiak A, Kruk M, Zysk A, Debski A, Knaapen P, Schumacher SP, Barbero U, Witkowski A, Kepka C, Opolski MP. Computed tomography perfusion and angiography in patients with chronic total occlusion undergoing percutaneous coronary intervention. Atherosclerosis. 2023 Sep;381:117174. doi: 10.1016/j.atherosclerosis.2023.06.080. Epub 2023 Jun 25.
PubMed 37400307
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Coronary Chronic Total Occlusion on Myocardial Perfusion on Dual-energy Computed Tomography (COPACABANA Trial)
- ClinicalTrials.gov ID
- NCT04465526
- Acronym / sponsor ID
- COPACABANA / 2.31/III/2020
- Conditions
- Coronary Occlusion, Myocardial Ischemia, Myocardial Perfusion Imaging, Percutaneous Coronary Intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- National Institute of Cardiology, Warsaw, PolandUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 10 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| computed tomography perfusion imagingThe 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. | Diagnostic test | – |
Primary outcome
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.
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.
3 secondary outcomes
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
Radiation dose 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
Time frame: 1 day and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Derived from this study: PubMed 37400307Kwiecinski J, Oleksiak A, Kruk M, Zysk A, Debski A, Knaapen P, Schumacher SP, Barbero U, Witkowski A, Kepka C, Opolski MP. Computed tomography perfusion and angiography in patients with chronic total occlusion undergoing percutaneous coronary intervention. Atherosclerosis. 2023 Sep;381:117174. doi: 10.1016/j.atherosclerosis.2023.06.080. Epub 2023 Jun 25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Occlusion and Myocardial Ischemia, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of stress computed tomography perfusion imaging for myocardial ischemia assessment in patients with a coronary chronic total occlusion (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04465526, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024.