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Clinical Trials in Spain / NCT07454096
Starting soon Phase 4

Application of Radiomics for Diagnosis and Follow-up of Cardiovascular Device Infections: PREDICT Study

NCT07454096 · tracked via the Priya Life Science Spain tracker
Sponsor
Fundacion Clinic per a la Recerca Biomédica
Phase
Phase 4
Started
2026-04-30
Last updated
2026-03-06

Condition(s) studied

Cardiac DiseaseDevice Related Infection

Investigational drug(s) / intervention(s)

PET/CT imaging

PET/CT imaging: Inclusion will occur after device implantation and informed consent signature. FDG-PET/CT imaging will be performed at approximately 1 month and 12 months post-implantation. These patients will not receive any specific treatment related to the study, beyond the procedures planned in the study schedule to record potential adverse events related to FDG administration and to facilitate the communication of imaging results. All medical management will otherwise follow standard clinical practice.

Study summary

Single center, open-label, phase IV clinical trial to study the application of radiomics in molecular imaging for diagnosis and follow-up of CVDIs. The study will include three populations:

* Retrospective cohort (2018-2025)
* Prospective cohort (2026-2027)
* Control group (prospective)

Eligibility

Sex
ALL
Min age
18 Years
Max age
84 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Age ≥ 18 years. * Implanted cardiovascular device (prosthetic valve, TAVI, CIED, vascular graft/endograft). * For infected cohorts: patients studied by FDG-PET with definitive diagnosis of CVDI based on multidisciplinary evaluation. * For control group: no clinical suspicion of infection at time of inclusion. * Written Informed consent provided (prospective cohort and control group). * Women of child-bearing potential must have a negative pregnancy test in serum or urine before the inclusion in the study and agree to use highly effective contraceptive methods during the study. Highly effective contraceptive methods will include: intrauterine device, bilateral tubal occlusion, vasectomized partner and sexual abstinence (only if refraining from heterosexual intercourse during the period of twelve months of duration of the study). Exclusion Criteria: * Inability to undergo FDG-PET due to contraindications (e.g., allergies, claustrophobia). * Pregnancy or breastfeeding. * Incomplete clinical data or lack of access to imaging studies. * Refusal or withdrawal of informed consent (for control and prospective cohort).

Primary outcome measure(s)

  • To assess the diagnostic performance of radiomics applied to FDG-PET in patients with cardiovascular device infections (CVDIs), in comparison with standard visual and semiquantitative analysis. — 1 month and 12 months
    Diagnostic accuracy of radiomics applied to FDG-PET for CVDIs, compared with conventional visual and semiquantitative interpretation.

Trial sites (1)

FacilityCityRegionStatus
Hospital Clinic Barcelona Barcelona Barcelona

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07454096 on ClinicalTrials.gov ↗ ← All trials in Spain