Application of Radiomics for Diagnosis and Follow-up of Cardiovascular Device Infections: PREDICT Study
Starting soon · Phase 4
Conditions studied: Cardiac Disease, Device Related Infection
In brief
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)
Key facts
- Study ID
- NCT07454096
- Run by
- Fundacion Clinic per a la Recerca Biomédica
- People needed
- 200
- Starts
- 2026-04-30
- Expected to finish
- 2028-04-30
- Last updated by the study team
- 2026-03-06
Who can join
Age: 18 and older, up to 84. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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).
Where it is running
- Hospital Clinic Barcelona — Barcelona, Barcelona, Spain
Full record on ClinicalTrials.gov
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