Application of Radiomics for Diagnosis and Follow-up of Cardiovascular Device Infections: PREDICT Study (PREDICT)

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)

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiac Disease; Device Related Infection
• Intervention / Treatment: Radiation: PET/CT imaging

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Maria Joyera; Phone Number: +34932775400; Email: joyera@recerca.clinic.cat
• Study Contact Backup: Name: Marta Hernandez-Meneses, Dr; Phone Number: +34932775400; Email: MHMENESES@clinic.cat

Study Locations

• Spain
  • Barcelona
    • Barcelona, Barcelona, Spain, 08036
      • Hospital Clinic Barcelona
      • Contact: Marta Hernández-Meneses, Dr.; Email: MHMENESES@clinic.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
No Intervention: 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.
Experimental: 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)	Radiation: 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 results. All medical management will otherwise follow standard clinical practice.

What is the study measuring?

Primary 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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fundacion Clinic per a la Recerca Biomédica

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: March 2, 2026
• First Submitted That Met QC Criteria: March 2, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Infections; Pathological Conditions, Signs and Symptoms; Heart Diseases; Prosthesis-Related Infections
• Other Study ID Numbers: 2025-524624-21-00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No