Sponsor study identifier
Secondary identifiers
NIH
interventional
200
1 country
1
Study Start
April 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2, 2026
Actual (reported)March 6, 2026
Actual (reported)April 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
April 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
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.
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hospital Clinic Barcelona
Barcelona, Barcelona, 08036, Spain
First Submitted
March 2, 2026
First Posted
March 6, 2026
Study Start
April 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Do Nasogastric Tubes After Cardiac Surgery Reduce Nausea and Vomiting
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)
Contact the study team to confirm eligibility.
Primary Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
March 6, 2026
Record last verified: 2026-03
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Source: ClinicalTrials.gov.
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