Left Ventricular FunctionNCT04228874
Effect of Stent Size on Dyssynchrony
An observational study of Left Ventricular Function, run by Benha University at 1 site in Egypt.
Trial summary
the effect of stent size and number on left ventricular mechanical dyssynchrony after PCI using drug eluting stent is not clear enough Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Left Ventricular Function
- What is being tested?
- coronary artery stents
- Type of treatment
- Medical device
- How many people
- 265 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 1 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients with electively stented LAD lesion with DES were enrolled in the study
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 10Show fewer
- Complicated or unsuccessful procedure,
- Patients with significant degenerative changes,
- Patients with previous STEMI,
- and dropped patients from follow up were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Short Term Effect of Stent Size and Number on Left Ventricular Mechanical Dyssynchrony After Elective PCI to Left Anterior Descending Artery
the effect of stent size and number on left ventricular mechanical dyssynchrony after PCI using drug eluting stent is not clear enough
Read the detailed 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).
- Conditions
- Left Ventricular Function
- Being tested
- coronary artery stents
- Keywords
- Stent length, Stent diameter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronary artery stentsDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
left ventricular systolic function
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start1 Jan 2018
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, shaimaa Mostafa, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04228874
- Sponsor's protocol ID
- dyssynchrony
- Status last verified
- Jan 2020
- First submitted
- 19 Dec 2019
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: included in the research
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Short Term Effect of Stent Size and Number on Left Ventricular Mechanical Dyssynchrony After Elective PCI to Left Anterior Descending Artery
- ClinicalTrials.gov ID
- NCT04228874
- Acronym / sponsor ID
- dyssynchrony
- Conditions
- Left Ventricular Function
- Keywords
- Stent length, Stent diameter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 14 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
the effect of stent size and number on left ventricular mechanical dyssynchrony after PCI using drug eluting stent is not clear enough
Detailed 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients with electively stented LAD lesion with DES were enrolled in the study
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (10 listed)
- patients with Bundle branch block (BBB),
- Previous percutaneous coronary intervention (PCI),
- Previous coronary artery bypass graft (CABG),
- Rhythm other than sinus,
- Rheumatic heart disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coronary artery stentsCoronary 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. | Device | – |
Primary outcome
left ventricular systolic function
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Individual participant dataSharing planned: Undecided. included in the research
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Ventricular Function, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
left ventricular systolic function (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2020.