Advanced Coronary Plaque Morphology Assessment Using Photon-counting Detection and Invasive Coronary Imaging (ACDC)

November 18, 2024 updated by: Eva Steinacher, Medical University of Vienna

This clinical trial aims to compare non-invasive photon-counting detector computed tomography (PCD-CT) with invasive intravascular imaging (IVI) for post-interventional follow-up in patients with coronary artery disease (CAD).

Participants will undergo post-interventional follow-up using both PCD-CT and coronary angiography with IVI. Researchers will test qualitative and quantitative PCD-CT results for non-inferiority to IVI regarding stent evaluation and detection of in-stent restenosis and plaque morphology.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

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

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

Description

Inclusion Criteria:

  • Signed written informed consent
  • DES in proximal coronary vessel segments

Exclusion Criteria:

- Any conditions that may interfere with the safety or efficacy of CCTA

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative comparison of PCD-CT and IVI in stent evaluation
Time Frame: Within 1 year
Comparison of post-PCI minimal stent area, stent diameter, stent lumen visualization, coronary wall visualization
Within 1 year
Qualitative comparison of PCD-CT and IVI in stent evaluation
Time Frame: Within 1 year
Two experienced radiologists/cardiologists will independently rate image noise and stent artefacts (1 = inadequate; 5 = excellent)
Within 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative comparison of PCD-CT and IVI for the evaluation of in-stent restenosis
Time Frame: Within 1 year
Severity of stenosis: Calculation of the percentage (%) of lumen diameter and lumen are stenosis with the appropriate CCTA and IVI analysis software
Within 1 year
Quantitative comparison of PCD-CT and IVI for the evaluation of plaque morphology
Time Frame: Within 1 year
Plaque morphology: Characterization of plaque components using Hounsfield units (HU) with the appropriate CCTA and IVI analysis software
Within 1 year
Qualitative comparison of PCD-CT and IVI for the evaluation of in-stent restenosis and plaque morphology
Time Frame: Within 1 year
Two experienced radiologists/cardiologists will independently rate the visualization of in-stent restenosis and plaque morphology using a five-point scale (1 = inadequate; 5 = excellent)
Within 1 year

Collaborators and Investigators

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

Sponsor

Medical University of Vienna

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)

November 20, 2024

Primary Completion (Estimated)

July 15, 2025

Study Completion (Estimated)

July 15, 2026

Study Registration Dates

First Submitted

June 11, 2024

First Submitted That Met QC Criteria

July 8, 2024

First Posted (Actual)

July 12, 2024

Study Record Updates

Last Update Posted (Estimated)

November 20, 2024

Last Update Submitted That Met QC Criteria

November 18, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACDC_2547

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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