NCT03253315

Brief Summary

The pericardium is a double-walled sac containing the heart and the roots of the great vessels. The pericardial sac has two layers, a serous visceral l layer (also known as epicardium when it comes into contact with the myocardium) and a fibrous parietal layer. It encloses the pericardial cavity, which contains pericardial fluid. The pericardium fixes the heart to the mediastinum, gives protection against infection and provides lubrication for the heart. Pericardial diseases may be either isolated disease or part of a systemic disease Diseases of the pericardium present clinically in one of several ways

  • Acute and recurrent pericarditis
  • Pericardial effusion without major hemodynamic compromise
  • Cardiac tamponade with cardiac compromise
  • Constrictive pericarditis

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 17, 2017

Completed
15 days until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

August 17, 2017

Status Verified

August 1, 2017

Enrollment Period

1 year

First QC Date

August 7, 2017

Last Update Submit

August 15, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Echocardiographic signs

    1. normal cardiac size by echocardiography (measurable by echocardiographic probe) 2. normal thickening of pericardium by echocardiography .(measurable by echocardiographic probe)

    one month

Eligibility Criteria

Age12 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

patients who above one year of age up to 18 years diagnosed with pericarditis and/or pericardial effusions are candidates for the study.

You may qualify if:

  • Children with pericarditis and/or pericardial effusion above one year of age detected clinically and by echocardiography

You may not qualify if:

  • children below one year of age. - children with malignant effusion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Egypt

Location

MeSH Terms

Conditions

Pericarditis

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
15 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 7, 2017

First Posted

August 17, 2017

Study Start

September 1, 2017

Primary Completion

September 1, 2018

Study Completion

April 1, 2019

Last Updated

August 17, 2017

Record last verified: 2017-08

Locations