Coronary Artery DiseaseCT-PRECISIONNCT03709836
Computed Tomography Angiography Prediction Score for Side Branch Occlusion
An observational study of Coronary Artery Disease, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
Trial summary
Lesions involving coronary bifurcations account for approximately 20% of all percutaneous coronary interventions (PCI). Revascularization within bifurcation sites remains technically challenging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 363 participants
- Where
- 1 sitePoland
- Study dates
- 25 Sep 2018to 1 Jan 2019
- 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: The study population consists of patients undergoing preprocedural coronary CTA before attempted PCI involving coronary bifurcation with a significant SB. All consecutive patients meeting all inclusion criteria and no exclusion criteria will be included within the CT-PRECISION registry.
Who may be able to join
- Patients referred for attempted PCI of a bifurcation lesion with a significant SB as part of their standard of care
- Initial stenting of the main branch with a provisional approach to the SB
- Performance of dual-source coronary CTA within 30 days before attempted PCI
Who cannot join
- Age <18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Computed Tomography Angiography Prediction Score for Side Branch Occlusion in Coronary Bifurcation Intervention (CT-PRECISION)
Lesions involving coronary bifurcations account for approximately 20% of all percutaneous coronary interventions (PCI). Revascularization within bifurcation sites remains technically challenging. While the most optimal interventional treatment strategy for bifurcation lesions is still debatable, side branch (SB) occlusion is one of the most serious procedural complications with prevalence rates over 7%.
Numerous mechanisms of the SB occlusion (e.g. plaque or carina shift, coronary artery dissection, thromboembolism, coronary artery spasm, etc) have been postulated. Regardless of the cause, loss of the SB is associated with increased risk of periprocedural mortality and myocardial infarction. Therefore, PCI involving coronary bifurcation mandates consideration of the risk of SB compromise. The CT-PRECISION (Computed Tomography angiography PREdiCtIon score for SIde branch Occlusion in coronary bifurcation interventioN) registry was designed to evaluate the application of coronary computed tomography angiography (coronary CTA) for the prediction of SB occlusion during percutaneous revascularization of bifurcation lesions. The main purpose of this single-center study is to develop a noninvasive CTA-based prediction tool to determine the procedural outcome of PCI in bifurcation lesions.
Read the detailed description
Coronary CTA allows for precise and noninvasive evaluation of coronary bifurcation lesions. Pre-procedural planning for coronary revascularization using CTA provides detailed characterization of bifurcation anatomy and morphology including the spatial distribution of coronary plaque. To date there has been no compiled CTA-based prediction model for SB occlusion in coronary bifurcation intervention.
The CT-PRECISION registry is a retrospective observational cohort study of patients undergoing preprocedural coronary CTA before PCI involving coronary bifurcation lesions between January 2010 and July 2018. The study is designed to enroll 400 consecutive patients undergoing elective main vessel stenting with a provisional approach to the SB at a single high-volume PCI center.
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, Coronary bifurcation lesion, Coronary angiography, Coronary computed tomography angiography, Percutaneous coronary intervention
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
SB occlusion
SB occlusion defined as a any decrease in Thrombolysis in Myocardial Infarction (TIMI) flow grade or the absence of flow in the SB after main vessel stenting
Measured: intraprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start25 Sep 2018
- Primary completion1 Dec 2018
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Retrospective
- Enrolment
- 363 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam D. Staruch, MD, Principal investigator, Department of Interventional Cardiology, and Angiology, Institute of Cardiology, Warsaw, PolandMaksymilian P. Opolski, MD, PhD, Study chair, Department of Interventional Cardiology, and Angiology, Institute of Cardiology, Warsaw, PolandAdam Witkowski, MD, PhD, Study chair, Department of Interventional Cardiology, and Angiology, Institute of Cardiology, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03709836
- Sponsor's protocol ID
- 2.43/III/16
- Acronym
- CT-PRECISION
- Status last verified
- Oct 2020
- First submitted
- 15 Oct 2018
- Last updated
- 2 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Grodecki K, Cadet S, Staruch AD, Michalowska AM, Kepka C, Wolny R, Pregowski J, Kruk M, Debski M, Debski A, Michalowska I, Slomka PJ, Witkowski A, Dey D, Opolski MP. Noncalcified plaque burden quantified from coronary computed tomography angiography improves prediction of side branch occlusion after main vessel stenting in bifurcation lesions: results from the CT-PRECISION registry. Clin Res Cardiol. 2021 Jan;110(1):114-123. doi: 10.1007/s00392-020-01658-1. Epub 2020 May 8.
PubMed 32385529Opolski MP, Grodecki K, Staruch AD, Michalowska AM, Kepka C, Wolny R, Knaapen P, Schumacher SP, Pregowski J, Kruk M, Debski M, Debski A, Michalowska I, Witkowski A. Accuracy of RESOLVE score derived from coronary computed tomography versus visual angiography to predict side branch occlusion in percutaneous bifurcation intervention. J Cardiovasc Comput Tomogr. 2020 May-Jun;14(3):258-265. doi: 10.1016/j.jcct.2019.11.007. Epub 2019 Nov 21.
PubMed 31806391
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computed Tomography Angiography Prediction Score for Side Branch Occlusion in Coronary Bifurcation Intervention (CT-PRECISION)
- ClinicalTrials.gov ID
- NCT03709836
- Acronym / sponsor ID
- CT-PRECISION / 2.43/III/16
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, Coronary bifurcation lesion, Coronary angiography, Coronary computed tomography angiography, Percutaneous coronary intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 363 participants (actual)
- Lead sponsor
- National Institute of Cardiology, Warsaw, PolandUniversity, hospital or other
- Study start
- 25 Sep 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 17 Oct 2018 (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.
Lesions involving coronary bifurcations account for approximately 20% of all percutaneous coronary interventions (PCI). Revascularization within bifurcation sites remains technically challenging. While the most optimal interventional treatment strategy for bifurcation lesions is still debatable, side branch (SB) occlusion is one of the most serious procedural complications with prevalence rates over 7%.
Numerous mechanisms of the SB occlusion (e.g. plaque or carina shift, coronary artery dissection, thromboembolism, coronary artery spasm, etc) have been postulated. Regardless of the cause, loss of the SB is associated with increased risk of periprocedural mortality and myocardial infarction. Therefore, PCI involving coronary bifurcation mandates consideration of the risk of SB compromise. The CT-PRECISION (Computed Tomography angiography PREdiCtIon score for SIde branch Occlusion in coronary bifurcation interventioN) registry was designed to evaluate the application of coronary computed tomography angiography (coronary CTA) for the prediction of SB occlusion during percutaneous revascularization of bifurcation lesions. The main purpose of this single-center study is to develop a noninvasive CTA-based prediction tool to determine the procedural outcome of PCI in bifurcation lesions.
Detailed description
Coronary CTA allows for precise and noninvasive evaluation of coronary bifurcation lesions. Pre-procedural planning for coronary revascularization using CTA provides detailed characterization of bifurcation anatomy and morphology including the spatial distribution of coronary plaque. To date there has been no compiled CTA-based prediction model for SB occlusion in coronary bifurcation intervention.
The CT-PRECISION registry is a retrospective observational cohort study of patients undergoing preprocedural coronary CTA before PCI involving coronary bifurcation lesions between January 2010 and July 2018. The study is designed to enroll 400 consecutive patients undergoing elective main vessel stenting with a provisional approach to the SB at a single high-volume PCI center.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients undergoing preprocedural coronary CTA before attempted PCI involving coronary bifurcation with a significant SB. All consecutive patients meeting all inclusion criteria and no exclusion criteria will be included within the CT-PRECISION registry.
Key inclusion criteria (3 listed)
- Patients referred for attempted PCI of a bifurcation lesion with a significant SB as part of their standard of care
- Initial stenting of the main branch with a provisional approach to the SB
- Performance of dual-source coronary CTA within 30 days before attempted PCI
Key exclusion criteria (1 listed)
- Age <18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
SB occlusion
Time frame: intraprocedural
SB occlusion defined as a any decrease in Thrombolysis in Myocardial Infarction (TIMI) flow grade or the absence of flow in the SB after main vessel stenting
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 2 Nov 2020.
- Derived from this study: PubMed 32385529Grodecki K, Cadet S, Staruch AD, Michalowska AM, Kepka C, Wolny R, Pregowski J, Kruk M, Debski M, Debski A, Michalowska I, Slomka PJ, Witkowski A, Dey D, Opolski MP. Noncalcified plaque burden quantified from coronary computed tomography angiography improves prediction of side branch occlusion after main vessel stenting in bifurcation lesions: results from the CT-PRECISION registry. Clin Res Cardiol. 2021 Jan;110(1):114-123. doi: 10.1007/s00392-020-01658-1. Epub 2020 May 8.
- Derived from this study: PubMed 31806391Opolski MP, Grodecki K, Staruch AD, Michalowska AM, Kepka C, Wolny R, Knaapen P, Schumacher SP, Pregowski J, Kruk M, Debski M, Debski A, Michalowska I, Witkowski A. Accuracy of RESOLVE score derived from coronary computed tomography versus visual angiography to predict side branch occlusion in percutaneous bifurcation intervention. J Cardiovasc Comput Tomogr. 2020 May-Jun;14(3):258-265. doi: 10.1016/j.jcct.2019.11.007. Epub 2019 Nov 21.
- Individual participant dataSharing planned: Undecided
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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.
Adam D. Staruch, MD principal investigator
Department of Interventional Cardiology, and Angiology, Institute of Cardiology, Warsaw, Poland
Maksymilian P. Opolski, MD, PhD study chair
Department of Interventional Cardiology, and Angiology, Institute of Cardiology, Warsaw, Poland
Adam Witkowski, MD, PhD study chair
Department of Interventional Cardiology, and Angiology, Institute of Cardiology, Warsaw, Poland
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 Artery Disease, 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 3 inclusion and 1 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 2 Nov 2020. 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?
SB occlusion (time frame: intraprocedural). 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 NCT03709836, which also lists 2 linked publications.
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 2 Nov 2020.