Epipericardial Fat NecrosisepipericardialNCT01903980
Epipericardial Fat Necrosis: A Misdiagnosed Condition
An observational study of Epipericardial Fat Necrosis, run by Hospital Sirio-Libanes at 2 sites in Brazil.
Trial summary
Epipericardial fat necrosis is a benign and self-limited condition that mainly curses with acute pleuritic chest pain and therefore must be an important differential diagnosis for patients in emergency department (ED). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Epipericardial Fat Necrosis
- How many people
- 10 participants
- Where
- 2 sitesBrazil
- Study dates
- Jun 2013to Jul 2013
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients from the emergency department of SIrio-Libanes Hospital who performed a chest CT due to any reason
Who may be able to join
- patients with imaging criteria of EFN (defined as a round fat attenuation lesion with peripheral stranding located in the epipericardial fat)
Who cannot join
- no exclusion criteria
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Hospital Sirio Libanes
São Paulo, São Paulo, 01080050
Hospital Sirio-Libanes
São Paulo, São Paulo, 01080050
About this study
Epipericardial fat necrosis is a benign and self-limited condition that mainly curses with acute pleuritic chest pain and therefore must be an important differential diagnosis for patients in emergency department (ED). The knowledge of characteristics symptoms and correct management may avoid misdiagnosis or mistakes with other severe conditions like pulmonary embolism, pericarditis or acute coronary disease.
Despite the importance of this entity, only fewer than 40 cases have been reported since 1957, when the condition was first described.
We have seen a couple of similar cases in our institution during a short period of time, and we suspect that these numbers doesn't mean the real prevalence of epipericardial fat necrosis, so maybe this condition could be underdiagnosed. Instead, there isn't a study that tried to estimate an incidence of this entity.
- Conditions
- Epipericardial Fat Necrosis
- Being tested
- No intervention. It is a retrospective study
- Keywords
- Epipericardial Fat Necrosis, Fat Necrosis, Chest Pain, Pericardial Necrosis, Pleuritic pain
- Medical subject headings
- Fat Necrosis, Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention. It is a retrospective studyOther
No intervention. It is a retrospective study
| Study group | Role | What they receive |
|---|---|---|
| EFN Cases | Cases of patients with epipericardial fat necrosis CT findings Receives: Other: No intervention. It is a retrospective study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determinate the incidence of epipericardial fat necrosis
Measured: 18 months
Secondary outcomes (1)
Identify misdiagnosed cases of epipericardial fat necrosis
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epipericardial Fat NecrosisStudies 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Hospital Sirio-Libanes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karina de Souza Giassi, Hospital Sirio-Libanes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01903980
- Sponsor's protocol ID
- Epipericardial Fat Necrosis
- Other IDs
- Pericardial Necrosis
- Acronym
- epipericardial
- Status last verified
- Jul 2013
- First submitted
- 17 Jul 2013
- Last updated
- 19 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epipericardial Fat Necrosis: A Misdiagnosed Condition
- ClinicalTrials.gov ID
- NCT01903980
- Acronym / sponsor ID
- epipericardial / Epipericardial Fat Necrosis
- Conditions
- Epipericardial Fat Necrosis
- Keywords
- Epipericardial Fat Necrosis, Fat Necrosis, Chest Pain, Pericardial Necrosis, Pleuritic pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hospital Sirio-LibanesUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 19 Jul 2013 (estimated)
- 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.
Epipericardial fat necrosis is a benign and self-limited condition that mainly curses with acute pleuritic chest pain and therefore must be an important differential diagnosis for patients in emergency department (ED). The knowledge of characteristics symptoms and correct management may avoid misdiagnosis or mistakes with other severe conditions like pulmonary embolism, pericarditis or acute coronary disease.
Despite the importance of this entity, only fewer than 40 cases have been reported since 1957, when the condition was first described.
We have seen a couple of similar cases in our institution during a short period of time, and we suspect that these numbers doesn't mean the real prevalence of epipericardial fat necrosis, so maybe this condition could be underdiagnosed. Instead, there isn't a study that tried to estimate an incidence of this entity.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EFN Cases | – | Other: No intervention. It is a retrospective studyCases of patients with epipericardial fat necrosis CT findings |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients from the emergency department of SIrio-Libanes Hospital who performed a chest CT due to any reason
Key inclusion criteria (1 listed)
- patients with imaging criteria of EFN (defined as a round fat attenuation lesion with peripheral stranding located in the epipericardial fat)
Key exclusion criteria (1 listed)
- no exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention. It is a retrospective studyNo intervention. It is a retrospective study | Other | EFN Cases |
Primary outcome
Determinate the incidence of epipericardial fat necrosis
Time frame: 18 months
1 secondary outcome
Identify misdiagnosed cases of epipericardial fat necrosis
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2013.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epipericardial Fat Necrosis, run by Hospital Sirio-Libanes at 2 sites in Brazil.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 19 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determinate the incidence of epipericardial fat necrosis (time frame: 18 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 19 Jul 2013.