Using PCR to improve diagnosis and management of infective endocarditis
The Role of Polymerase Chain Reaction in the Management of Patients With Infective Endocarditis: Modern Diagnostic and Therapeutic Concepts
This study tests if a special blood test can help doctors better diagnose and manage infective endocarditis in patients who need heart surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 2 sites (Roma and 1 other locations) |
| Trial ID | NCT05791357 on ClinicalTrials.gov |
What this trial studies
This study aims to prospectively evaluate the added diagnostic value of broad range polymerase chain reaction (PCR) targeting the 16 ribosomal DNA in patients diagnosed with infective endocarditis who are candidates for surgical therapy. The study is structured into four phases: screening, pre-operative clinical assessment, cardiac surgery, and follow-up. During these phases, patients will undergo various assessments including blood cultures, imaging, and intraoperative data collection to enhance the understanding of their condition and treatment outcomes. Follow-up evaluations will monitor patients' clinical status post-surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old diagnosed with infective endocarditis requiring heart valve replacement surgery.
Not a fit: Patients under 18 years old or those unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic accuracy and management strategies for patients with infective endocarditis.
How similar studies have performed: While the use of PCR in infectious disease diagnostics is established, this specific application in infective endocarditis is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. patients older than 18 years, with diagnosis of IE on a native or prosthetic valve and with a surgical indication for heart valve replacement using extracorporeal circulation (CPB). 2. patients who have signed informed consent to the partecipation of the study Exclusion criteria: 1. patients younger than 18 years 2. Failure to sign consent for personal data processing and/or study participation 3. Participation in other experimental studies 4. Patients who did not complete the examinations under study (culture test on blood and excised valve, molecular tests)
Where this trial is running
Roma and 1 other locations
- IRCCS Fondazione Policlinico Universitario Agostino Gemelli — Roma, Italy (Recruiting)
- Policlinico Agostino Gemelli — Roma, Italy (Recruiting)
Study contacts
- Principal investigator: Massimo Massetti — Fondazione Universitaria Policliino Gemelli IRCSS
- Study coordinator: Natalia Pavone, MD, PHD
- Email: natalia.pavone@policlinicogemelli.it
- Phone: 0630154814
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.