Impact of OCT Imaging on Decision Making During PCI in ACS Patients

June 22, 2020 updated by: Amir Khalifa Mahfouz Khalifa, Assiut University

Impact of Optical Coherence Tomography Imaging on Decision-making During Percutaneous Coronary Intervention in Patients Presented With Acute Coronary Syndromes

Optical coherence tomography (OCT) provides valuable information to guide percutaneous coronary intervention (PCI) in acute coronary syndrome (ACS) regarding lesion preparation, stent sizing, and stent optimization.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OCT can be used in acute coronary syndrome (ACS). ACS has more complex culprit lesion morphologies and larger extent of coronary atherosclerosis compared with stable coronary artery disease. The detailed vascular information obtained by OCT may impact PCI in ACS, and which may improve acute results and late outcomes of PCI. Stent expansion immediately after PCI is a strong predictor of late outcomes of PCI, and it is associated with late clinical outcomes in many previous trials.

Study Type

Observational

Enrollment (Actual)

390

Contacts and Locations

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

Study Locations

  • Japan
      • Wakayama, Japan, 641-8509
        • Wakayama Medical University

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

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient either underwent PCI with angiography alone or OCT guided and is grouped accordingly

Description

Inclusion Criteria:

  • Patients presented with acute coronary syndrome.
  • PCI was done to them with stent implantation.

Exclusion Criteria:

  • Multivessel PCI at the index procedure.
  • Patients with ACS due to graft failure post CABG.
  • Patients treated with no stent implantation.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
OCT-guided PCI
PCI procedure was done with intra-coronary imaging OCT.
Device: OCT-guided PCI
using optical coherence tomography imaging to help PCI procedure
Angiography-guided PCI
PCI procedure was done without any intra-coronary imaging assistance, guided by angiography alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent difference in lumen expansion in stent treated lesion
Time Frame: Immediately after the procedure
Compare residual percent diameter stenosis, percent area stenosis, and acute lumen gain between the two groups.
Immediately after the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical outcomes at 1 year follow up
Time Frame: During 1 year following the index procedure
Cardiac death, MI, clinical-driven target-lesion revascularization (TLR), and stroke
During 1 year following the index procedure

Collaborators and Investigators

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

Sponsor

Assiut University

Collaborators

Wakayama Medical University

Investigators

  • Study Chair: Yehia T Kishk, MD, Assiut University
  • Study Chair: Hossam H Ali, MD, Assiut University
  • Study Chair: Ahmed Abdel-Galeel, MD, Assiut University
  • Study Chair: Takashi Akasaka, MD, PhD, Wakayama Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

January 1, 2019

Primary Completion (Actual)

March 31, 2020

Study Completion (Actual)

April 30, 2020

Study Registration Dates

First Submitted

June 20, 2020

First Submitted That Met QC Criteria

June 20, 2020

First Posted (Actual)

June 23, 2020

Study Record Updates

Last Update Posted (Actual)

June 24, 2020

Last Update Submitted That Met QC Criteria

June 22, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OCT in ACS patients

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Nothing

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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