NCT04228874

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
265

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2019

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 14, 2020

Completed
Last Updated

January 14, 2020

Status Verified

January 1, 2020

Enrollment Period

1.9 years

First QC Date

December 19, 2019

Last Update Submit

January 13, 2020

Conditions

Keywords

Stent lengthStent diameter

Outcome Measures

Primary Outcomes (1)

  • left ventricular systolic function

    3 months

Interventions

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.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

adult patients with electively stented LAD lesion with DES were enrolled in the study

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

shaimaa Mostafa

Cairo, Egypt

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

December 19, 2019

First Posted

January 14, 2020

Study Start

January 1, 2018

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

January 14, 2020

Record last verified: 2020-01

Locations