Coronary Artery DiseaseNCT04581837
Predictors and Outcomes of Occlusion of Jailed Side Branches Following Main Vessel Coronary Artery Stenting
An observational study of Coronary Artery Disease, run by Assiut University.
Trial summary
Assessment of possible predictors of occlusion of jailed side branches following main vessel coronary artery stenting and detection of clinical, electrocardiographic and echocardiographic changes following occlusion of jailed side branches postprocedural and at 3 months follow-up. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- 2D-speckle tracking echocardiography
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2021to 1 Jan 2024
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients presenting for elective PCI will undergo 2D-STE before the procedure and if found to have bifurcation lesion will undergo 2D-STE within 24 hours after the procedure and after 3 months
Who may be able to join
- Patients presenting to cathlab for elective PCI along one year duration
- patients who have significant main vessel lesion subtending large, sizable (≥2mm) side branches (Medina 1,0,0 / 1,1,0 / 0,1,0)
Who cannot join
- acute myocardial infarction
- previous CABG
- LV EF<50%
- baseline SWMA in the territory of the vessel to be stented
- totally occluded main vessel.
- small (<2mm) side branch
Show all 9Show fewer
- any ostial, mid or distal significant side branch disease at baseline.
- true bifurcation lesions (Medina 1,0,1 / 1,1,1 / 0,1,1) with upfront 2-stent strategy.
- advanced renal impairement
Trial locations and contacts
No sites are listed yet.
About this study
Assessment of possible predictors of occlusion of jailed side branches following main vessel coronary artery stenting and detection of clinical, electrocardiographic and echocardiographic changes following occlusion of jailed side branches postprocedural and at 3 months follow-up.
Read the detailed description
Coronary bifurcation lesion (CBL) involves coronary artery stenosis adjacent to and/or including the origin of a significant side branch (SB) 1. Treatment of bifurcation lesions constitute about 15% of coronary interventions and are consequently of major clinical interest 2. Even in the modern era of per-cutaneous coronary intervention(PCI) with stent implantation, treatment of bifurcations is hampered by a higher event rate and requires longer procedure time, more radiation exposure, and higher volumes of contrast material compared with non-bifurcation lesions 3 .
Occlusion of large side branches (SBs) may result in significant adverse clinical events 4. Occlusion of jailed sizable septal and right ventricular (RV) side branches (non-classic bifurcations) is often overlooked following left anterior descending (LAD) and right coronary artery (RCA) main vessel stenting, respectively. Most of the operators decline intervening in these side branches on contrary to classic bifurcations as diagonals and obtuse marginal branches, for example. Whether or not intervening with these occluded jailed side branches have clinical implications or even sub clinical left ventricular (LV) dysfunction was not previously elucidated and warrants studying.
Left ventricular function is an important predictor of outcome in patients with coronary artery disease (CAD). Extensive myocardial ischemia can cause decreased LV contractility and function 5. Conventional echocardiography enables us to identify significant left ventricular dysfunction but not sub-clinical dysfunction [10]. Two-dimensional speckle tracking echocardiography (2D-STE) allows for an angle-independent evaluation of myocardial strain, and provides comprehensive information on LV myocardial contractility. Thus, 2DSTE is superior in detecting subtle deterioration of contractility 6 .
In this study, investigators tried to explore the possible predictors and outcomes following occlusion of jailed side branches after main vessel coronary artery stenting, in both classic and non-classic bifurcations, and whether intervening via various techniques would have clinical benefit.
- Conditions
- Coronary Artery Disease
- Being tested
- 2D-speckle tracking echocardiography
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2D-speckle tracking echocardiographyDiagnostic test
Two-dimensional speckle tracking echocardiography (2D-STE) allows for an angle-independent evaluation of myocardial strain, and provides comprehensive information on LV myocardial contractility. Thus, 2DSTE is superior in detecting subtle deteriorations of contractility. we will take 2D speckle tracking views for LV and RV strain (4ch, 2ch, 3ch, RV modified view).
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of changes in sub-clinical LV dysfunction after elective PCI to bifurcation lesions by detecting changes in LV global and regional longitudinal strain by 2D-speckle tracking echocardiography.
Measured: post-procedural (immediately after procedure) and at 3-months follow-up
Secondary outcomes (1)
Detection of peri-procedural myocardial injury (PMI)
Measured: within 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start1 Jan 2021 (estimated)
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Adel Mekawy, Assiut University
- Investigators
- Amr A Youssif, Doctorate, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04581837
- Sponsor's protocol ID
- 2DSTEBIFURCATION
- Status last verified
- Oct 2020
- First submitted
- 9 Sep 2020
- Last updated
- 9 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yurtdas M, Asoglu R, Ozdemir M, Asoglu E. An Upfront Two-Stent Strategy for True Coronary Bifurcation Lesions with A Large Side Branch in Acute Coronary Syndrome: A Two-Year Follow-Up Study. Medicina (Kaunas). 2020 Feb 29;56(3):102. doi: 10.3390/medicina56030102.
PubMed 32121323Palinggi BP, Firman D. Carina Bifurcation Angle and Side Branch Occlusion in Coronary Bifurcation Lesions Intervention: Angiographic Lesions Characteristic Role in Determining Its Relation. Int J Angiol. 2019 Jun;28(2):137-141. doi: 10.1055/s-0038-1676042. Epub 2018 Nov 29.
PubMed 31384112Tsuchida K, Colombo A, Lefevre T, Oldroyd KG, Guetta V, Guagliumi G, von Scheidt W, Ruzyllo W, Hamm CW, Bressers M, Stoll HP, Wittebols K, Donohoe DJ, Serruys PW. The clinical outcome of percutaneous treatment of bifurcation lesions in multivessel coronary artery disease with the sirolimus-eluting stent: insights from the Arterial Revascularization Therapies Study part II (ARTS II). Eur Heart J. 2007 Feb;28(4):433-42. doi: 10.1093/eurheartj/ehl539. Epub 2007 Jan 31.
PubMed 17267457Zhang D, Xu B, Yin D, Li Y, He Y, You S, Qiao S, Wu Y, Yan H, Yang Y, Gao R, Dou K. Predictors and Periprocedural Myocardial Injury Rate of Small Side Branches Occlusion in Coronary Bifurcation Intervention. Medicine (Baltimore). 2015 Jun;94(25):e992. doi: 10.1097/MD.0000000000000992.
PubMed 26107685Mohamed Alsenbsey, Basem Asham, Sanaa Shaker Aly, Samar Sayed Ahmed, A. B. Role of insulin resistance in essential hypertensive patients in Qena Governorate, Egypt. Al-Azhar Assiut Med. J. 16, 99-104 (2018).
Wang P, Liu Y, Ren L. Evaluation of left ventricular function after percutaneous recanalization of chronic coronary occlusions : The role of two-dimensional speckle tracking echocardiography. Herz. 2019 Apr;44(2):170-174. doi: 10.1007/s00059-017-4663-1. Epub 2018 Jan 16.
PubMed 29340717
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors and Outcomes of Occlusion of Jailed Side Branches Following Main Vessel Coronary Artery Stenting
- ClinicalTrials.gov ID
- NCT04581837
- Acronym / sponsor ID
- 2DSTEBIFURCATION
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 9 Oct 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.
Assessment of possible predictors of occlusion of jailed side branches following main vessel coronary artery stenting and detection of clinical, electrocardiographic and echocardiographic changes following occlusion of jailed side branches postprocedural and at 3 months follow-up.
Detailed description
Coronary bifurcation lesion (CBL) involves coronary artery stenosis adjacent to and/or including the origin of a significant side branch (SB) 1. Treatment of bifurcation lesions constitute about 15% of coronary interventions and are consequently of major clinical interest 2. Even in the modern era of per-cutaneous coronary intervention(PCI) with stent implantation, treatment of bifurcations is hampered by a higher event rate and requires longer procedure time, more radiation exposure, and higher volumes of contrast material compared with non-bifurcation lesions 3 .
Occlusion of large side branches (SBs) may result in significant adverse clinical events 4. Occlusion of jailed sizable septal and right ventricular (RV) side branches (non-classic bifurcations) is often overlooked following left anterior descending (LAD) and right coronary artery (RCA) main vessel stenting, respectively. Most of the operators decline intervening in these side branches on contrary to classic bifurcations as diagonals and obtuse marginal branches, for example. Whether or not intervening with these occluded jailed side branches have clinical implications or even sub clinical left ventricular (LV) dysfunction was not previously elucidated and warrants studying.
Left ventricular function is an important predictor of outcome in patients with coronary artery disease (CAD). Extensive myocardial ischemia can cause decreased LV contractility and function 5. Conventional echocardiography enables us to identify significant left ventricular dysfunction but not sub-clinical dysfunction [10]. Two-dimensional speckle tracking echocardiography (2D-STE) allows for an angle-independent evaluation of myocardial strain, and provides comprehensive information on LV myocardial contractility. Thus, 2DSTE is superior in detecting subtle deterioration of contractility 6 .
In this study, investigators tried to explore the possible predictors and outcomes following occlusion of jailed side branches after main vessel coronary artery stenting, in both classic and non-classic bifurcations, and whether intervening via various techniques would have clinical benefit.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients presenting for elective PCI will undergo 2D-STE before the procedure and if found to have bifurcation lesion will undergo 2D-STE within 24 hours after the procedure and after 3 months
Key inclusion criteria (2 listed)
- Patients presenting to cathlab for elective PCI along one year duration
- patients who have significant main vessel lesion subtending large, sizable (≥2mm) side branches (Medina 1,0,0 / 1,1,0 / 0,1,0)
Key exclusion criteria (9 listed)
- acute myocardial infarction
- previous CABG
- LV EF<50%
- baseline SWMA in the territory of the vessel to be stented
- totally occluded main vessel.
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 |
|---|---|---|
| 2D-speckle tracking echocardiographyTwo-dimensional speckle tracking echocardiography (2D-STE) allows for an angle-independent evaluation of myocardial strain, and provides comprehensive information on LV myocardial contractility. Thus, 2DSTE is superior in detecting subtle deteriorations of contractility. we will take 2D speckle tracking views for LV and RV strain (4ch, 2ch, 3ch, RV modified view). | Diagnostic test | – |
Primary outcome
Detection of changes in sub-clinical LV dysfunction after elective PCI to bifurcation lesions by detecting changes in LV global and regional longitudinal strain by 2D-speckle tracking echocardiography.
Time frame: post-procedural (immediately after procedure) and at 3-months follow-up
1 secondary outcome
Detection of peri-procedural myocardial injury (PMI)
Time frame: within 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2020.
- Background: PubMed 32121323Yurtdas M, Asoglu R, Ozdemir M, Asoglu E. An Upfront Two-Stent Strategy for True Coronary Bifurcation Lesions with A Large Side Branch in Acute Coronary Syndrome: A Two-Year Follow-Up Study. Medicina (Kaunas). 2020 Feb 29;56(3):102. doi: 10.3390/medicina56030102.
- Background: PubMed 31384112Palinggi BP, Firman D. Carina Bifurcation Angle and Side Branch Occlusion in Coronary Bifurcation Lesions Intervention: Angiographic Lesions Characteristic Role in Determining Its Relation. Int J Angiol. 2019 Jun;28(2):137-141. doi: 10.1055/s-0038-1676042. Epub 2018 Nov 29.
- Background: PubMed 17267457Tsuchida K, Colombo A, Lefevre T, Oldroyd KG, Guetta V, Guagliumi G, von Scheidt W, Ruzyllo W, Hamm CW, Bressers M, Stoll HP, Wittebols K, Donohoe DJ, Serruys PW. The clinical outcome of percutaneous treatment of bifurcation lesions in multivessel coronary artery disease with the sirolimus-eluting stent: insights from the Arterial Revascularization Therapies Study part II (ARTS II). Eur Heart J. 2007 Feb;28(4):433-42. doi: 10.1093/eurheartj/ehl539. Epub 2007 Jan 31.
- Background: PubMed 26107685Zhang D, Xu B, Yin D, Li Y, He Y, You S, Qiao S, Wu Y, Yan H, Yang Y, Gao R, Dou K. Predictors and Periprocedural Myocardial Injury Rate of Small Side Branches Occlusion in Coronary Bifurcation Intervention. Medicine (Baltimore). 2015 Jun;94(25):e992. doi: 10.1097/MD.0000000000000992.
- BackgroundMohamed Alsenbsey, Basem Asham, Sanaa Shaker Aly, Samar Sayed Ahmed, A. B. Role of insulin resistance in essential hypertensive patients in Qena Governorate, Egypt. Al-Azhar Assiut Med. J. 16, 99-104 (2018).
- Background: PubMed 29340717Wang P, Liu Y, Ren L. Evaluation of left ventricular function after percutaneous recanalization of chronic coronary occlusions : The role of two-dimensional speckle tracking echocardiography. Herz. 2019 Apr;44(2):170-174. doi: 10.1007/s00059-017-4663-1. Epub 2018 Jan 16.
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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.
Amr A Youssif, Doctorate study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Assiut University.
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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 9 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed A Mekawy, bachelor (+201004051049, ahmed.adel6871@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of changes in sub-clinical LV dysfunction after elective PCI to bifurcation lesions by detecting changes in LV global and regional longitudinal strain by 2D-speckle tracking echocardiography. (time frame: post-procedural (immediately after procedure) and at 3-months follow-up). 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 NCT04581837, which also lists 6 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 9 Oct 2020.