Cardiac DiseasePhase 4PREDICTNCT07454096
Application of Radiomics for Diagnosis and Follow-up of Cardiovascular Device Infections: PREDICT Study
A Phase 4 study testing PET/CT imaging in people with Cardiac Disease and Device Related Infection, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Disease, Device Related Infection
- What is being tested?
- PET/CT imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 30 Apr 2026to 30 Apr 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 84 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Hospital Clinic Barcelona
Barcelona, Barcelona, 08036
Marta Hernández-Meneses, Dr., MHMENESES@clinic.cat
About this study
Official title: Application of Radiomics in Molecular Imaging (18F-FDG-PET/CT) for Diagnosis and Follow-up of Cardiovascular Device Infections: PREDICT Study
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)
Read the 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.
- Conditions
- Cardiac Disease, Device Related Infection
- Being tested
- PET/CT imaging
- Medical subject headings
- Heart Diseases, Prosthesis-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CT imagingRadiation
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 group | Role | What they receive |
|---|---|---|
| Retrospective cohort (2018-2025) | No intervention | 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) | No intervention | 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) | Experimental | 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) Receives: Radiation: PET/CT imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month and 12 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: 1 month and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start30 Apr 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- study will include three populations: * Retrospective cohort (2018-2025) * Prospective cohort (2026-2027) * Control group (prospective)
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinic per a la Recerca Biomédica
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07454096
- Sponsor's protocol ID
- 2025-524624-21-00
- Other IDs
- 2025
- Acronym
- PREDICT
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Radiomics in Molecular Imaging (18F-FDG-PET/CT) for Diagnosis and Follow-up of Cardiovascular Device Infections: PREDICT Study
- ClinicalTrials.gov ID
- NCT07454096
- Acronym / sponsor ID
- PREDICT / 2025-524624-21-00
- Conditions
- Cardiac Disease, Device Related Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fundacion Clinic per a la Recerca BiomédicaUniversity, hospital or other
- Study start
- 30 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- study will include three populations: * Retrospective cohort (2018-2025) * Prospective cohort (2026-2027) * Control group (prospective)
| Arm | Type | Receives |
|---|---|---|
| Retrospective cohort (2018-2025) | No intervention | –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) | No intervention | –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) | Experimental | Radiation: PET/CT imagingThis 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) |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET/CT imagingInclusion 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. | Radiation | Control group (prospective) |
Primary outcome
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.
Time frame: 1 month and 12 months
Diagnostic accuracy of radiomics applied to FDG-PET for CVDIs, compared with conventional visual and semiquantitative interpretation.
2 secondary outcomes
To evaluate the role of radiomics in monitoring suppressive antimicrobial therapy in patients with retained infected devices.
Time frame: 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.
Time frame: 1 month and 12 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PET/CT imaging in people with Cardiac Disease and Device Related Infection, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marta Hernandez-Meneses, Dr (+34932775400, MHMENESES@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 1 month and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.