Application of Coronary Artery Chronic Total Occlusion Scoring Systems (CTO-PCI)

May 31, 2023 updated by: Khaled Saber Abdelaal Qayed, Assiut University

Application of Coronary Artery Chronic Total Occlusion (CTO) Scoring Systems Detecting Their Prediction Ability on CTO Percutaneous Coronary Intervention (PCI) Procedures

Studying the prediction ability of different CTO scoring systems on Asian CTO PCI population with their relation to technical success and developing a newer stepwise approach depending on these CTO scoring systems for choosing the suggested successful approach considering collateral channel assessment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Study of applying the Japenese CTO, Castle and Progress CTO scores on all coronary CTO PCI cohort done at national Taiwan university hospital (NTUH)

Study tools:

  1. Basal demographic data collection( age, cardiovascular risk factors, patients clinical data, lesion characteristics, periprocedural complications).

  2. The Japanese Chronic Total Occlusion (J-CTO) score calculated for assessment of CTO procedures complexity and predict the likelihood of guide wire crossing within 30 min, as assembled by Morino et al.

    The J-CTO score is the sum of the following 5 binary parameters: blunt proximal cap, calcification, bending >45°, length of occluded segment >20 mm, and previously failed PCI attempt. Each of these independent variables was assigned a value of 1 when present. With increasing probability of difficulty of wire crossing from 0 as easy till 5 as very difficult.

  3. Also, the PROGRESS-CTO score calculated (reference website: https://www.progresscto.org/cto with evaluation of 4 baseline angiographic characteristics (proximal cap ambiguity, absence of retrograde collaterals, moderate or severe tortuosity, and LCX CTO) used to determine the likelihood of technical success with CTO PCI. Each of these independent variables was assigned a value of 1 when present. With increasing probability of difficulty of success from 0 as easy till 5 as very difficult.

  4. Euro CTO CASTLE scoring calculation

    The CASTLE (coronary artery bypass graft history, age, stump anatomy, tortuosity degree, length of occlusion, and extent of calcification) model applied retrospectively on the patients with every item taking 1 point if present And Technical failure rates range from 8% (CASTLE score 0 to 1) to 35% (CASTLE score ≥4).

  5. Collateral assessment including type (septal, epicardial or bypass grafts), size by Werner classification [is graded as: 0, no visible connection between the donor and the recipient coronary artery; 1, thread-like connection between the donor and the recipient coronary artery; 2, side-branch like connection between the donor and the recipient coronary artery], tortuosity degree as by the CC scoring system of the NTUH--> Channel tortuosity caculated as the presence of ≥2 high-frequency, successive curves (within 2 mm) in the context of epicardial collaterals and ≥1 high-frequency curve that failed to uncoil in diastole for septal channels (thus a measure of channel distensibility). A high-frequency curve is defined as a curve that is >180° occurring within a segment length <3× the diameter of the collateral.

And all these scores references and calculation items are mentioned in the references below….

Study Type

Observational

Enrollment (Estimated)

650

Contacts and Locations

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

Study Contact

Study Locations

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

Sampling Method

Probability Sample

Study Population

coronary CTO PCI patients done by experienced high volume operator at national Taiwan university hospital (NTUH) with their data available for analysis

Description

Inclusion Criteria:

  • All coronary CTO PCI procedures done at national Taiwan university hospital (NTUH) with their data available for analysis from 2015 till the study data collection step.

Exclusion Criteria:

  • Patients whom data not completed

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparison of the effecacy of using CTO scoring systems (J-CTO scoring, Castle Score and progress scoring along with the CC scoring in prediction of technical success.
Time Frame: Two months
comaprling the three CTO scores for all CTO PCI patients done by experienced operator ( J-CTO scoring, Castle Score and progress scoring ) for prediction of technical success with higher scores indicating higher probability of difficulty along with the CC scoring in predicting higher chances of technical success in retrograde CTO PCI patients.
Two months

Collaborators and Investigators

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

Sponsor

Assiut University

Collaborators

National Taiwan University Hospital

Investigators

  • Study Chair: Salwa Rushdy, Professor, Assiut University
  • Study Director: Paul Kao, Professor, National Taiwan 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)

April 1, 2023

Primary Completion (Estimated)

July 1, 2023

Study Completion (Estimated)

August 1, 2023

Study Registration Dates

First Submitted

May 17, 2023

First Submitted That Met QC Criteria

May 31, 2023

First Posted (Actual)

June 1, 2023

Study Record Updates

Last Update Posted (Actual)

June 1, 2023

Last Update Submitted That Met QC Criteria

May 31, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • CTO-PCI scores application

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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