Calcification on CTCA of a CTO and PCI Outcomes

May 21, 2024 updated by: Vinoda Sharma, Sandwell & West Birmingham Hospitals NHS Trust

Characteristics of Calcification in a Chronic Total Occlusion on Computed Tomography Coronary Angiogram and Percutaneous Coronary Intervention Outcomes- a Single Centre Observational Study

A chronic total occlusion (CTO) is present in 15-20% of patients who are referred for invasive coronary angiography. CTO Percutaneous Coronary Intervention (PCI) procedure success rates have increased over the years and can be as high as 90% when performed by high-volume CTO operators.Procedurally, excess calcification in the CTO anatomy is one factor which makes it difficult to complete the procedure or obtain ideal stent expansion. Excess calcification is best identified by Computed Tomography Coronary Angiography (CTCA) rather than invasive angiography.

The investigators plan to retrospectively evaluate CTCA in patients who underwent CTO PCI and correlate calcification characteristics with CTO PCI outcomes and tools utilised for calcium modification.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Cohort: All coronary CTO patients who underwent a PCI attempt and also underwent CTCA at our centre in the last 5 years.

Method of identifying and consenting patients: Screening of our local database to identify suitable patients who fulfil the inclusion/exclusion criteria. These patients will be telephoned and the consent form and participant information sheet will be maile dot them along with a self addressed stamped envelope.On receipt of the consent form, we will countersign it and return a copy to the patient. Consented patients' images and reports of the CTCA and CTO PCI will be reviewed.

Characteristics of calcification in the CTO on the CTCA will be evaluated including site, density and quantity of calcification. This will be correlated with CTO PCI outcomes of success and failure. Also this will be correlated with use of calcium modification tools for the CTO PCI.

  • Baseline and demographic as well as procedural data will be compared with CTO PCI outcomes and presence/characteristics of calcification.
  • Characteristics of calcification in the CTO assessed will include: site, density in Hounsfield units and quantity.
  • Site of calcification (proximal, body or distal) will be correlated with the CTO PCI outcome by chi square analysis.
  • Calcium density (in Hounsfield Units) on the CTCA will be correlated with successful versus failed CTO PCI by ROC curve analysis.
  • Quantity of calcification will be assessed as a percentage of the cross section of the CTO body (as <50%, 50-75% and 75-100%) and correlated with CTO PCI success by contingency analysis.
  • Use of calcium modification tools will be correlated with CTO PCI outcome (success or failure) and density of calcification on CTCA (ROC curve and ANOVA).
  • Categorical variables will be compared by the chi square or Fisher's test and continuous variables will be compared by the Mann Whitney U test. In addition, based on CTO PCI outcome of success or failure, patients will be compared for demographics and procedural variables.
  • Categorical variables will be presented as percentage and compared with the chi square or Fisher's test
  • Continuous variables will be presented as median (range) and compared with student's t-test or Mann Whitney test.

Study Type

Observational

Enrollment (Estimated)

100

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 Contact Backup

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with coronary CTO who underwent attempt at PCI and also underwent CTCA

Description

Inclusion Criteria:

  • Patients meeting all the below criteria will be included

    • ≥18 years
    • Previous CTO PCI attempt in the last 5 years
    • Undergone CTCA either pre or post CTO PCI
    • Adequate CTCA images for analysis

Exclusion Criteria:

  • Patients meeting any of the following criteria will be excluded

    • <18 years of age
    • Did not undergo CTCA
    • Inadequate/degraded CTCA images

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
CTO patients who underwent attempted PCI
Patients with coronary CTO who underwent attempt at PCI and also underwent a CTCA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of characteristics of calcification with CTO PCI outcome (success or failure)
Time Frame: up to 24 hours
Success or failure
up to 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Utility of calcium modifying tools for the CTO PCI procedure and correlation with severity of calcification
Time Frame: up to 24 hours
Percentage of patients in whom any calcium modifying tool was used and the corelation of this with the severity of calcification.
up to 24 hours

Collaborators and Investigators

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

Sponsor

Sandwell & West Birmingham Hospitals NHS Trust

Investigators

  • Principal Investigator: Vinoda Sharma, FRCP, Sandwell & West Birmingham Hospitals NHS Trust

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 (Estimated)

July 1, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

May 3, 2024

First Submitted That Met QC Criteria

May 9, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 22, 2024

Last Update Submitted That Met QC Criteria

May 21, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRAS Project ID: 333718

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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