CARDIOVASCular Unexpected fiNdings in patiEnts Undergoing eXecution of PET/tc

NCT06774391 | Completed

• 1 other identifier: CV-UNEXPET/TC
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this single-center observational study is to retrospectively evaluate incidental findings at the cardiovascular level in a selection of patients referred to the O.U. of Nuclear Medicine of Policlinco S.Orsola-Malpighi who underwent a PET/CT investigation. In particular, the present study is aimed to explore in such patients occasional findings of hypercapturing radiopharmaceutical findings specifically referred to:

• infection inflammatory processes of implantable cardiac devices (ICDs, pacemakers);
• phenomena affecting the atria during episodes of atrial fibrillation;
• infection and inflammatory processes of cardiovascular structures (endocarditis, myocarditis, pericarditis, amyloidosis). Patients who performed PET/CT examination at the Sant'Orsola-Malpighi Nuclear Medicine O.U. during the period between 01/01/2017 and 31/12/2019 will be included in this registry. Any cardiovascular events that occurred within the Sant'Orsola-Malpighi Polyclinic setting and up to 3 months after the date of the PET/CT scan will be subsequently evaluated.

Conditions

Cardiovascular Disease Other

Keywords

CIED; amyloidosis; cardiomyopathies; atrial fibrillation; PET/TC

Outcome Measures

Primary Outcomes (1)

• Prevalence of all incidental cardiovascular findings hypercapturing 18-fluorodeoxyglucose and not justified by history

  The primary objective of the study is to assess the prevalence of all incidental cardiovascular findings hypercapturing the radiopharmaceutical and not justified by history, with subsequent characterization of the sites in relation to the indication for performing PET-CT.

  At enrollment

Secondary Outcomes (1)

• incidence of hospitalization for cardiovascular causes in subjects with incidental findings hypercapturing the radiopharmaceutical, compared with subjects without such findings compared with negative subjects

  From enrollment to 3 months after

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who performed PET/CT examinations at the Sant'Orsola-Malpighi Nuclear Medicine OU in the period between 01/01/2017 and 31/12/2019. Based on the services provided, it is estimated about 35,000-45,000 total examinations. Of these, through the infortmatic approach described just above, only patients of interest will be selected: an estimated 1,000. It should be noted that in the event that each patient has performed more than one PET/CT scan for the purpose of the study, a different patient ID will be identified for each investigation performed.

You may qualify if:

• All patients referred to the U.O. of Nuclear Medicine of Policlinico S.Orsola-Malpighi who underwent a PET/CT investigation from 01/01/2017 to 31/12/2019.
• age \> 18 years old

You may not qualify if:

• Pregnant women

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS - Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Amyloidosis; Cardiomyopathies; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Igor Diemberger, Prof, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 14, 2025
• Study Start: January 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: January 14, 2025

Record last verified: 2024-11

Locations

IT (1)