Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06186336

Feasibility of a Deep Learning-based Algorithm for Non-invasive Assessment of Vulnerable Coronary Plaque

The primary objective of this study is to assess the accuracy in terms of sensitivity, specificity, negative and positive predicted values of the DL-based algorithm with respect to correct identification of the plaque and associated vulnerability grade.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Chronic Coronary Syndrome Acute Coronary Syndrome Angina Pectoris Angina, Stable Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stable Angina Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale Di Voghera, Azienda Socio-Sanitaria Territoriale di Pavia

Pavia, Lombardy, 27100, Italy

Location contact

Pietro Broglia, MD

CONTACT

[email protected]

+39 0383 695682

Pietro Broglia, MD

CONTACT

About this study

Data collected in this study will be used for technology development, scientific evaluation, education, and regulatory submissions for future products. This is a pre-market, open label, prospective, non-randomized clinical research study conducted at one site in Italy. The product being researched is the Deep Learning-based (DL) algorithm for non-invasive detection of vulnerable coronary plaque.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients referred for a clinically indicated CCTA and ICA with OCT imaging examinations;
  • Diagnosis of chronic coronary syndrome, known CAD, or stable angina; AND,
  • Patients with ACS that may undergo a CCTA and not refer directly to the Cath lab for revascularization procedures.

Exclusion criteria

  • Contradictions to contrast;
  • Contraindications for beta blocker;
  • BMI >30;
  • High heart rate ≥75 BPM;
  • Atrial Fibrillation;
  • Arrythmia or irregular heartbeats;
  • Any prior coronary revascularization;
  • Presence of pacemaker or implantable cardioverter defibrillator; OR,
  • Patients with TAVI/TAVR.

Treatment and study plan

Deep Learning-based Vulnerable Plaque Detection and Assessment Tool

Other

Scanning requirements for the clinically indicated CCTA and ICA with OCT will be performed according to current site(s) guidelines and procedures. Administration of medications (such as contrast agents and potentially beta-blockers and other medications) will be given according to standard hospital care.

This is a prospective research study evaluating an investigational product. The tool's use is intended for research purposes and is not intended as a substitute for required medical care. The CCTA and ICA with OCT will be processed in real-time using the site's locally available post-processing tools in order to guide the subject's medical care. Once the ICA with OCT is complete, the de-identified CCTA data will be inputted in the investigational tool.

The clinically indicated CCTA and the ICA with OCT will both take approximately 1 hour and will take place within 10 days. No additional imaging is needed as part of the study.

Primary outcomes

  1. Data Collection

    Time frame: Through study completion, an average of 1 year

    Number of subjects with raw CCTA and ICA with OCT data

Secondary outcomes

  1. Accuracy of Tool

    Time frame: Through study completion, an average of 1 year

    Sensitivity, specificity, negative, and positive predicted values of the DL-based algorithm with respect to correct identification of the plaque and associated vulnerability grade in comparison to qualified readers

  2. Safety Events

    Time frame: Through study completion, an average of 1 year

    Number of AEs, SAEs, and product issues

Study contacts

Contact information is provided by the study sponsor or research team.

Melissa Challman

CONTACT

[email protected]

8582213007

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Collaborators

  • Azienda Socio-Sanitaria Territoriale di Pavia

Registry information

Acronym: FOCUS DL

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 2, 2024
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.