Impact of Stent Length and Diameter on Patients Undergoing Primary PCI

May 15, 2020 updated by: Nada Deyaa, Assiut University

Impact of Stent Length and Diameter on Short Term Outcomes in Patients With ST Segment Elevation Myocardial Infarction Undergoing Primary PCI.

The goal of the study is to evaluate the Impact of coronary stent length and/or diameter in patients with ST segment myocardial infarction undergoing primary PCI, on Short term clinical outcomes.

Study Overview

Status

Unknown

Conditions

Detailed Description

  • ST segment elevation myocardial infarction is serious condition to the blood supply to the heart muscle. Rapid reperfusion of the ischemic myocardium using percutaneous coronary intervention (PCI) is the standard treatment for acute myocardial infarction (MI) to rescue the ischemic myocardium and reduce infarction size.

  • There are two types of stents:

    1. Drug-eluting stent which achieving local drug delivery to the injured blood vessel at the time of intervention, a drug is released from a polymer coating or loaded directly onto the stent (2). This is the best one.
    2. Bare metal stent is the old one and not effective as DES in reducing vascular restenosis by suppressing smooth muscle cell (SMC) proliferation.
  • The management of long coronary lesions by percutaneous coronary intervention (PCI) has become increasingly important because of the rising incidence of long or complex lesions in aging populations (3) Stent length has been considered as an important predictor of adverse events after PCI. The exact impact of lesion length on the short- and long-term clinical outcomes of DES implantations is not clear yet.
  • Myocardial necrosis complicates one-third of percutaneous coronary intervention (PCI) and may adversely affect the outcome(4)

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

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

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with ST segment elevation myocardial infarction undergoing primary PCI

Description

Inclusion Criteria:

  • Patients with ST segment myocardial infarction who are eligible for PCI.
  • All categories (all age groups and both sex groups)

Exclusion Criteria:

  • Patients with previous PCI.
  • Patients of ectatic lesions.
  • Patients with with multi vessel disease and suitable for CABG.
  • Patients with complex lesions including bifurcational lesions and LM stenting.

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: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prognosis of patients with ST segment myocardial infarction undergoing primary PCI
Time Frame: 3 months
prognosis will be measured with ECG and ECHO
3 months

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Principal Investigator: Nada Deyaa, Assiut University

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)

July 1, 2020

Primary Completion (Anticipated)

September 30, 2021

Study Completion (Anticipated)

January 28, 2022

Study Registration Dates

First Submitted

September 28, 2019

First Submitted That Met QC Criteria

September 28, 2019

First Posted (Actual)

October 1, 2019

Study Record Updates

Last Update Posted (Actual)

May 19, 2020

Last Update Submitted That Met QC Criteria

May 15, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • coronary stents

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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