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

NCT07454096 | Not Yet Recruiting Phase 4

• 1 other identifier: 2025-524624-21-00
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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)

Conditions

Cardiac Disease; Device Related Infection

Outcome Measures

Primary Outcomes (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.

  Diagnostic accuracy of radiomics applied to FDG-PET for CVDIs, compared with conventional visual and semiquantitative interpretation.

  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.

  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.

  1 month and 12 month

Study Arms (3)

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)

Radiation: PET/CT imaging

Interventions

PET/CT imaging RADIATION

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.

Control group (prospective)

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• Written Informed consent provided (prospective cohort and control group).

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).

Sponsors & Collaborators

• Fundacion Clinic per a la Recerca Biomédica: lead

Study Sites (1)

Hospital Clinic Barcelona

Barcelona, Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Heart Diseases; Prosthesis-Related Infections

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Marta Hernandez-Meneses, Dr

CONTACT

+34932775400; MHMENESES@clinic.cat

Maria Joyera

CONTACT

+34932775400; joyera@recerca.clinic.cat

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: study will include three populations: * Retrospective cohort (2018-2025) * Prospective cohort (2026-2027) * Control group (prospective)

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 6, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)