Predictors and Outcomes of Occlusion of Jailed Side Branches Following Main Vessel Coronary Artery Stenting
1 other identifier
observational
60
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2021
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2020
CompletedFirst Posted
Study publicly available on registry
October 9, 2020
CompletedStudy Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2024
CompletedOctober 9, 2020
October 1, 2020
1 year
September 9, 2020
October 5, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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.
post-procedural (immediately after procedure) and at 3-months follow-up
Secondary Outcomes (1)
Detection of peri-procedural myocardial injury (PMI)
within 3 months
Interventions
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).
Eligibility Criteria
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
You may qualify if:
- 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)
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (6)
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.
PMID: 32121323BACKGROUNDPalinggi 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.
PMID: 31384112BACKGROUNDTsuchida 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.
PMID: 17267457BACKGROUNDZhang 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.
PMID: 26107685BACKGROUNDMohamed 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).
BACKGROUNDWang 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.
PMID: 29340717BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Amr A Youssif, Doctorate
Assiut University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
September 9, 2020
First Posted
October 9, 2020
Study Start
January 1, 2021
Primary Completion
January 1, 2022
Study Completion
January 1, 2024
Last Updated
October 9, 2020
Record last verified: 2020-10