NCT06438393

Brief Summary

This project aims to improve direct patient care by reducing the risks of futile exposure to ionizing radiation and iodinated contrast in patients referred for coronary computed tomography angiography

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Jun 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Jun 2024Dec 2027

First Submitted

Initial submission to the registry

May 27, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 31, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

May 31, 2024

Status Verified

February 1, 2024

Enrollment Period

3 years

First QC Date

May 27, 2024

Last Update Submit

May 27, 2024

Conditions

Coronary Artery DiseaseCoronary Atheroscleroses

Keywords

Artificial intelligenceRadiomicsDeep learningCoronary artery diseaseNon-contrast computed tomography

Outcome Measures

Primary Outcomes (6)

  • Build a non-contrast CT radiomic signature of CAD

    3 years

  • Implement a machine learning model to discriminate patients with no CAD from patients with at least minimal disease (CAD-RADS=0 vs. CAD-RADS>0).

    3 years

  • Implement a machine learning model to detect coronary inflammation as defined using the Fat Attenuation Index (FAI ≥ -70.1 HU) in patients with no visible coronary plaque (CAD-RADS=0).

    3 years

  • Build a user-friendly plugin to facilitate users experience and distribution of our technology in clinical practice.

    3 years

  • Evaluate the real-world operationality and performance of the plugin in an international multicentre prospective cohort study.

    3 years

  • Create a national registry of cardiac CT

    3 years

Secondary Outcomes (2)

  • Setup a human blood biobank to identify the peripheral blood mononuclear cells (PBMCs) and plasma proteomics associated with CT data and clinical outcomes.

    3 years

  • Setup a public CT imaging repository

    3 years

Study Arms (1)

Stable chest pain and unknown CAD who underwent CTCA and CCS in the same scanning session

CAD: Presence of minimal coronary artery disease (i.e., coronary stenosis 0-25%) Normal coronary arteries: No visible coronary atherosclerosis

Diagnostic Test: CT coronary angiography and non-contrast CT

Interventions

CT coronary angiography and non-contrast CTDIAGNOSTIC_TEST

A CTCA is an X-ray computed tomography of the coronary arteries that allows visualization of coronary plaques with high temporal and spatial resolution, however, it implies the use of iodine contrast and exposition to clinically significant ionizing radiation. Non-contrast ECG-gated CT ("calcium score" - CCS image). A non-contrast cardiac CT for CCS can be performed very quickly with significantly lower radiation (\~6 times lower) than CTCA and without the need for contrast.

Also known as: Non-contrast computed tomography
Stable chest pain and unknown CAD who underwent CTCA and CCS in the same scanning session

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Stable chest pain patients with unknown CAD who underwent a CTCA with paired non-contrast CT

You may qualify if:

  • \- Patient with stable chest pain who underwent a CTCA

You may not qualify if:

  • Missing non-contrast CT image (coronary calcium score image)
  • Known coronary artery disease
  • Prior myocardial infarction
  • Prior PCI or CABG

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine of Porto

Porto, Portugal

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood samples for proteomics analysis

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2024

First Posted

May 31, 2024

Study Start

June 1, 2024

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

May 31, 2024

Record last verified: 2024-02

Locations

PT(1)