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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01903980
Other study ID # Epipericardial Fat Necrosis
Secondary ID Pericardial Necr
Status Completed
Phase N/A
First received July 17, 2013
Last updated July 17, 2013
Start date June 2013
Est. completion date July 2013

Study information

Verified date July 2013
Source Hospital Sirio-Libanes
Contact n/a
Is FDA regulated No
Health authority Brazil: Brazilian Research Ethics National Commitee
Study type Observational [Patient Registry]

Clinical 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). 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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date July 2013
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- patients with imaging criteria of EFN (defined as a round fat attenuation lesion with peripheral stranding located in the epipericardial fat)

Exclusion Criteria:

- no exclusion criteria

Study Design

Observational Model: Case-Crossover, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Intervention

Other:
No intervention. It is a retrospective study
No intervention. It is a retrospective study

Locations

Country Name City State
Brazil Hospital Sirio Libanes Sao paulo
Brazil Hospital Sirio-Libanes Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
Hospital Sirio-Libanes

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Other Describe Clinical and Radiological data of epipericardial fat necrosis 18 months Yes
Primary Determinate the incidence of epipericardial fat necrosis 18 months Yes
Secondary Identify misdiagnosed cases of epipericardial fat necrosis 18 months Yes