Feasibility of a Deep Learning-based Algorithm for Non-invasive Assessment of Vulnerable Coronary Plaque
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Deep Learning-based Vulnerable Plaque Detection and Assessment Tool.
- Who it may be relevant to
- Registry conditions: Chronic Coronary Syndrome, Coronary Artery Disease, Stable Angina, Acute Coronary Syndrome. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Other Deep Learning-based Vulnerable Plaque Detection and Assessment Tool
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 C
Primary outcome measures
- Data Collection [Time frame: Through study completion, an average of 1 year]
Secondary outcome measures (2)
- Accuracy of Tool [Time frame: Through study completion, an average of 1 year]
- Safety Events [Time frame: Through study completion, an average of 1 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Ospedale Di Voghera, Azienda Socio-Sanitaria Territoriale di Pavia — Pavia
Identifiers
NCT: NCT06186336 · 12019187648