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Clinical Trial NCT07454096 (PREDICT) for Cardiac Disease, Device Related Infection is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Application of Radiomics for Diagnosis and Follow-up of Cardiovascular Device Infections: PREDICT Study Phase 4 200 Open-Label
Clinical Trial NCT07454096 (PREDICT) is designed to study Diagnostic for Cardiac Disease, Device Related Infection. This Phase 4 interventional study is not yet recruiting. Enrollment is planned to begin on April 30, 2026 until the study accrues 200 participants. Led by Fundacion Clinic per a la Recerca Biomédica, this study is expected to complete by April 30, 2028. The latest data from ClinicalTrials.gov was last updated on March 6, 2026.
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:
•...
Show MoreOfficial Title
Application of Radiomics in Molecular Imaging (18F-FDG-PET/CT) for Diagnosis and Follow-up of Cardiovascular Device Infections: PREDICT Study
Conditions
Cardiac DiseaseDevice Related InfectionOther Study IDs
- PREDICT
- 2025-524624-21-00
NCT ID Number
Start Date (Actual)
2026-04-30
Last Update Posted
2026-03-06
Completion Date (Estimated)
2028-04-30
Enrollment (Estimated)
200
Study Type
Interventional
PHASE
Phase 4
Status
Not yet recruiting
Primary Purpose
Diagnostic
Design Allocation
Non-Randomized
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
No InterventionRetrospective 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 H...Show More | N/A |
No InterventionProspective 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 inf...Show More | N/A |
ExperimentalControl 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) | 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 resu...Show More |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | Diagnostic accuracy of radiomics applied to FDG-PET for CVDIs, compared with conventional visual and semiquantitative interpretation. | 1 month and 12 months |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
To evaluate the role of radiomics in monitoring suppressive antimicrobial therapy in patients with retained infected devices. | 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. | 1 month and 12 months |
To identify normal 18F-FDG uptake patterns in cardiovascular devices in patients without suspected infection, stratified by sex and time from device implantation. | Characterization of physiological 18F-FDG uptake patterns in cardiovascular device carriers without infection, stratified by sex and time since implantation. | 1 month and 12 month |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- 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).
- 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).
Fundacion Clinic per a la Recerca BiomédicaStudy Central Contact
Contact: Marta Hernandez-Meneses, Dr, +34932775400, [email protected]
Contact: Maria Joyera, +34932775400, [email protected]
1 Study Locations in 1 Countries
Barcelona
Hospital Clinic Barcelona, Barcelona, Barcelona, 08036, Spain
Marta Hernández-Meneses, Dr., Contact, [email protected]