Cardiac Disease, Device Related Infection
Conditions
Brief 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)
Detailed description
The study is a 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 be conducted in one Spanish hospital where two hundred patients will be included in the corresponding cohort according to their characteristics (see section "5.1 Description of Study Population"). The study will include three populations: • Retrospective cohort (2018-2025): patients with a confirmed CVDIs who underwent FDG-PET for diagnosis or follow-up. The retrospective cohort will include patients from 2018 to 2025 who have already undergone FDG-PET imaging and for whom complete clinical, microbiological, and therapeutic data are available. These data were collected under a previously approved protocol with CEIm (Clinical Research Ethics Committee) authorization: HCB/2015/0769 and HCB/2024/1173. No new procedures will be performed on retrospective patients; only a re-analysis of existing FDG-PET/CT scans using radiomics techniques will be conducted. • Prospective cohort (2026-2027): This cohort will include patients with a confirmed CVDI undergoing FDG-PET/CT as part of standard clinical care. Patients will be included before performing any FDG-PET/CT examination, which will be acquired after signing informed consent. All diagnostic and therapeutic procedures, including antibiotic or SAT when indicated, will follow standard clinical practice and will not be influenced by the study. Written informed consent will be obtained to authorize the use of their clinical and imaging data for research purposes. • Control group (prospective): This group will include 40 patients with recently implanted cardiovascular devices and no clinical suspicion of infection, distributed as follows: * 10 pacemakers, * 10 valvular prostheses, * 10 vascular prostheses, * 10 transcatheter aortic valve implants (TAVIs) 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.
Interventions
RADIATIONPET/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.
Sponsors
Fundacion Clinic per a la Recerca Biomédica
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
study will include three populations: * Retrospective cohort (2018-2025) * Prospective cohort (2026-2027) * Control group (prospective)
Eligibility
Sex/Gender
ALL
Age
18 Years to 84 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the role of radiomics in monitoring suppressive antimicrobial therapy in patients with retained infected devices. | 1 month and 12 months | Performance of AI-based predictive models (combining radiomic and clinical features) for: * Distinguishing infection vs. non-infection. * Predicting resolution of infection and supporting discontinuation of suppressive antimicrobial therapy. |
| To identify normal 18F-FDG uptake patterns in cardiovascular devices in patients without suspected infection, stratified by sex and time from device implantation. | 1 month and 12 month | Characterization of physiological 18F-FDG uptake patterns in cardiovascular device carriers without infection, stratified by sex and time since implantation. |
Countries
Spain
Contacts
CONTACTMarta Hernandez-Meneses, Dr
CONTACTMaria Joyera
Outcome results
None listed