Effect of Stent Size on Dyssynchrony

Left Ventricular Function Clinical Trial

Official title:

The Short Term Effect of Stent Size and Number on Left Ventricular Mechanical Dyssynchrony After Elective PCI to Left Anterior Descending Artery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04228874
• Other study ID #: dyssynchrony
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: January 2020
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

the effect of stent size and number on left ventricular mechanical dyssynchrony after PCI using drug eluting stent is not clear enough

Description:

Background: the effect of stent size and number on left ventricular mechanical dyssynchrony after PCI using drug eluting stent is not clear enough Aim: to study short term effect of stent size and number on left ventricular mechanical dyssynchrony after elective PCI to LAD artery.

Patients and methods: the study included 150 adult patients with electively stented LAD lesion with DES. Patients were evaluated pre PCI then follow up at 1m and 3m using tissue synchronization image (TSI).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 265
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• adult patients with electively stented LAD lesion with DES were enrolled in the study. Patients were evaluated pre PCI then follow up at 1m and 3m after PCI using TSI.

Exclusion Criteria:

• patients with Bundle branch block (BBB),

• Previous percutaneous coronary intervention (PCI),

• Previous coronary artery bypass graft (CABG),

• Rhythm other than sinus,

• Rheumatic heart disease,

• Prosthetic valve,

• Complicated or unsuccessful procedure,

• Patients with significant degenerative changes,

• Patients with previous STEMI,

• and dropped patients from follow up were excluded from the study.

Related Conditions & MeSH terms

• Left Ventricular Function

Intervention

Device:
• coronary artery stents
Coronary angiography was done for all the patients according to the Judkins technique. All images were evaluated by an experienced operator, significant coronary artery disease was defined as > 70 % luminar diameter stenos. The following data was obtained: Site of stent implantation within LAD. The first Diagonal branch serves as the boundary between the proximal and mid portion of the LAD. Thus, the portion of the artery prior to the origin of the 1st diagonal is known as the proximal LAD, while the segment just below the1st diagonal branch is the mid LAD. The distal segment of the LAD is the terminal third of the artery (Cao et al., 2017). Length, diameter and number of stents. TIMI flow after stent deployment.

Locations

Country	Name	City	State
Egypt	shaimaa Mostafa	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	left ventricular systolic function		3 months