Infective EndocarditisPET-NAVIENCT04792281
Impact of FDG-PET/CT on Management of Patients with Native Valve Infective Endocarditis
An observational study of Infective Endocarditis and Native Valve Endocarditis, run by Montreal Heart Institute at 6 sites in Canada.
Trial summary
The proposed study is a multicentric prospective observational cohort study of patients with suspected NVE. The study population includes those with Possible IE according to the modified Duke criteria and investigated at one of the 6 participating sites which include 2 cardiac centers, the MHI and the IUCPQ, as well… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infective Endocarditis, Native Valve Endocarditis
- How many people
- 97 participants
- Where
- 6 sitesCanada
- Study dates
- 31 Aug 2021to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes those with Possible IE according to the modified Duke criteria and investigated at one of the 5 participating sites
Who may be able to join
- 18 years of age or older, capable to provide informed consent;
- Referred for a FDG-PET/CT study
- Classified as having Possible IE prior to FDG-PET/CT imaging;
- Patients must be able to tolerate the physical/logistical requirements of a PET/CT scan.
Who cannot join
- Subjects with prosthetic cardiac valve and/or CIED;
- Pregnant or breastfeeding female;
- Body mass index > 45 kg/m2.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Canada6 sites, 6 recruiting
- Not yet recruiting
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 3E4
Daniel Juneau
- Recruiting
Montreal Heart Institute
Montreal, Quebec, H3l 3c1
Matthieu Pelletier-Galarneau, 5143763330 ext. 4418, matthieu.pelletier-galarneau@icm-mhi.org
- Recruiting
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Gad Abikhzer, 514-340-8222, gad101@hotmail.com
- Not yet recruiting
McGill University Health Center
Montreal, Quebec, H4A 3J1
Anthony Ciarallo, 514-934-1934, Anthony.Ciarallo.med@ssss.gouv.qc.ca
- Not yet recruiting
University Institute of Cardiology and Respirology of Quebec
Québec, Quebec, G1V 4G5
Jean-Francois Sarrazin
- Not yet recruiting
Centre Hospitalier de l'Universite de Sherbrooke
Sherbrooke, Quebec, J1H5H3
Etienne Rousseau
About this study
The proposed study is a multicentric prospective observational cohort study of patients with suspected NVE. The study population includes those with Possible IE according to the modified Duke criteria and investigated at one of the 6 participating sites which include 2 cardiac centers, the MHI and the IUCPQ, as well as 4 tertiary care centers, the Jewish General Hospital , the McGill University Health Centre and the CHUS.
- Conditions
- Infective Endocarditis, Native Valve Endocarditis
- Keywords
- PET/CT, FDG, Duke Criteria
- Medical subject headings
- Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspected native valve endocarditis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with Possible IE that will be appropriately reclassified
Proportion of patients with Possible IE that will be appropriately reclassified as Definite IE by the addition of FDG-PET to the Duke criteria.
Measured: 3 months
Secondary outcomes (9)
Sensitivity, specificity, and accuracy of FDG-PET for the detection of NVE
Measured: 3 months
Sensitivity, specificity, and accuracy of the Duke criteria with FDG-PET for detection of NVESensitivity, specificity, and accuracy of the Duke criteria with FDG-PET for detection of NVE
Measured: 3 months
Sensitivity, specificity, and accuracy of the Duke criteria with FDG-PET but excluding TEE for the detection of NVE
Measured: 3 months
Differences in maximal standardized uptake value (SUVmax) between infected and non-infected valves
Measured: 3 months
Differences target-to-background ratio (TBR) between infected and non-infected valves
Measured: 3 months
Proportion of patients in whom a TEE was not necessary to diagnose NVE through the addition of FDG-PET
Measured: 3 months
Proportion of patients with final diagnosis of IE with septic emboli detected on whole body FDGPET
Measured: 3 months
Differences in the rate of sub-optimal suppression protocol between males and females
Measured: 3 months
Proportion of patients with incidental cancer identified on FDG-PET
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start31 Aug 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infective EndocarditisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 97 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthieu Pelletier-Galarneau, MD MSc, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792281
- Sponsor's protocol ID
- MP-33-2020-2674
- Acronym
- PET-NAVIE
- Status last verified
- Nov 2024
- First submitted
- 5 Mar 2021
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of FDG-PET/CT on Management of Patients with Native Valve Infective Endocarditis
- ClinicalTrials.gov ID
- NCT04792281
- Acronym / sponsor ID
- PET-NAVIE / MP-33-2020-2674
- Conditions
- Infective Endocarditis, Native Valve Endocarditis
- Keywords
- PET/CT, FDG, Duke Criteria
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 97 participants (estimated)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study is a multicentric prospective observational cohort study of patients with suspected NVE. The study population includes those with Possible IE according to the modified Duke criteria and investigated at one of the 6 participating sites which include 2 cardiac centers, the MHI and the IUCPQ, as well as 4 tertiary care centers, the Jewish General Hospital , the McGill University Health Centre and the CHUS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected native valve endocarditis | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes those with Possible IE according to the modified Duke criteria and investigated at one of the 5 participating sites
Key inclusion criteria (4 listed)
- 18 years of age or older, capable to provide informed consent;
- Referred for a FDG-PET/CT study
- Classified as having Possible IE prior to FDG-PET/CT imaging;
- Patients must be able to tolerate the physical/logistical requirements of a PET/CT scan.
Key exclusion criteria (3 listed)
- Subjects with prosthetic cardiac valve and/or CIED;
- Pregnant or breastfeeding female;
- Body mass index > 45 kg/m2.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients with Possible IE that will be appropriately reclassified
Time frame: 3 months
Proportion of patients with Possible IE that will be appropriately reclassified as Definite IE by the addition of FDG-PET to the Duke criteria.
9 secondary outcomes
Sensitivity, specificity, and accuracy of FDG-PET for the detection of NVE
Time frame: 3 months
Sensitivity, specificity, and accuracy of the Duke criteria with FDG-PET for detection of NVESensitivity, specificity, and accuracy of the Duke criteria with FDG-PET for detection of NVE
Time frame: 3 months
Sensitivity, specificity, and accuracy of the Duke criteria with FDG-PET but excluding TEE for the detection of NVE
Time frame: 3 months
Differences in maximal standardized uptake value (SUVmax) between infected and non-infected valves
Time frame: 3 months
Differences target-to-background ratio (TBR) between infected and non-infected valves
Time frame: 3 months
Proportion of patients in whom a TEE was not necessary to diagnose NVE through the addition of FDG-PET
Time frame: 3 months
Proportion of patients with final diagnosis of IE with septic emboli detected on whole body FDGPET
Time frame: 3 months
Differences in the rate of sub-optimal suppression protocol between males and females
Time frame: 3 months
Proportion of patients with incidental cancer identified on FDG-PET
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Montreal Heart Institute
Montreal, Canada
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infective Endocarditis and Native Valve Endocarditis, run by Montreal Heart Institute at 6 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with Possible IE that will be appropriately reclassified (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.