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

October 5, 2020 updated by: Ahmed Adel Mekawy, Assiut University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
post-procedural (immediately after procedure) and at 3-months follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Detection of peri-procedural myocardial injury (PMI)
Time Frame: within 3 months
within 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Amr A Youssif, Doctorate, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2021

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

September 9, 2020

First Submitted That Met QC Criteria

October 5, 2020

First Posted (Actual)

October 9, 2020

Study Record Updates

Last Update Posted (Actual)

October 9, 2020

Last Update Submitted That Met QC Criteria

October 5, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2DSTEBIFURCATION

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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