Predictors and Outcomes of Occlusion of Jailed Side Branches Following Main Vessel Coronary Artery Stenting

NCT ID: NCT04581837

Last Updated: 2020-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2024-01-01

Brief Summary

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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

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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

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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2D-speckle tracking echocardiography

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).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Adel Mekawy

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amr A Youssif, Doctorate

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

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Ahmed A Mekawy, bachelor

Role: CONTACT

+201004051049

Heba M Elnaggar, Doctorate

Role: CONTACT

+201001963100

References

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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.

Reference Type BACKGROUND
PMID: 32121323 (View on PubMed)

Palinggi 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.

Reference Type BACKGROUND
PMID: 31384112 (View on PubMed)

Tsuchida 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.

Reference Type BACKGROUND
PMID: 17267457 (View on PubMed)

Zhang 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.

Reference Type BACKGROUND
PMID: 26107685 (View on PubMed)

Mohamed 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).

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 29340717 (View on PubMed)

Other Identifiers

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2DSTEBIFURCATION

Identifier Type: -

Identifier Source: org_study_id

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