Application of Radiomics for Diagnosis and Follow-up of Cardiovascular Device Infections: PREDICT… (NCT07454096) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Application of Radiomics for Diagnosis and Follow-up of Cardiovascular Device Infections: PREDICT Study
Spain200 participantsStarted 2026-04-30
Plain-language 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)
Who can participate
Age range
18 Years – 84 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
Timeframe: 1 month and 12 months
Trial details
NCT IDNCT07454096
SponsorFundacion Clinic per a la Recerca Biomédica