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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04581837
Collaborator
(none)
60
36

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: 2D-speckle tracking echocardiography

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

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Predictors and Outcomes of Occlusion of Jailed Side Branches Following Main Vessel Coronary Artery Stenting
Anticipated Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
Jan 1, 2024

Outcome Measures

Primary Outcome Measures

  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 Outcome Measures

  1. Detection of peri-procedural myocardial injury (PMI) [within 3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ahmed Adel Mekawy, principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT04581837
Other Study ID Numbers:
  • 2DSTEBIFURCATION
First Posted:
Oct 9, 2020
Last Update Posted:
Oct 9, 2020
Last Verified:
Oct 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 9, 2020