Prognostic Biomarkers in Patients With Acute Pericarditis

NCT02754713 | Unknown

• 1 other identifier: 14167/20/08/2009
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The study will aim at investigating novel plasma or imaging biomarkers in patients with acute pericarditis. All participants will be treated according to established clinical recommendations for the diagnosis and treatment of acute pericarditis. Study participants will undergo blood sampling for measurements of plasma biomarkers potentially involved in the pathogenesis of acute pericarditis. Imaging datasets from available imaging tests will be used to quantify imaging biomarkers. Patients will be followed up prospectively for up to 18 months. The prognostic value of plasma and/or imaging biomarkers for development of complications such as atrial fibrillation, pericarditis recurrences, constrictive pericarditis and/or the need to switch to 2nd line treatment will be sought.

Conditions

Pericarditis

Outcome Measures

Primary Outcomes (1)

• Development of of constrictive, recurrent or incessant pericarditis or poor response to NSAIDs treatment.

  Participants will be followed-up by scheduled visits at the Outpatients' Clinic at 2 weeks, 1 month, 2 months post-hospital discharge and every 3 months thereafter (or earlier if symptomatic) up to a total of 18 months.

  Up to 18 months after hospital discharge

Secondary Outcomes (1)

• Development of new atrial fibrillation

  Development of new atrial fibrillation at 7 days.

Study Arms (1)

Patients with acute pericarditis

300 patients with a first episode of acute pericarditis

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with first diagnosis of acute pericarditis

You may qualify if:

• Patients with first diagnosis of acute pericarditis

You may not qualify if:

• Not willing to provide written consent

Sponsors & Collaborators

• Hippocration General Hospital: lead

Study Sites (1)

Cardiology Department, Hippokration Hospital

Athens, Attica, 11527, Greece

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be collected for plasma biomarkers (e.g. circulating pro-inflammatory cytokines, miRNAs etc) Image datasets from available imaging tests will be also analysed to quantify imaging biomarkers (e.g. epicardial fat volume from computerised tomography, speckle-tracking analysis for cardiac ultrasound etc.).

MeSH Terms

Conditions

Pericarditis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Dimitris Tousoulis, Professor

  Cardiology Department, Hippokration Hospital, Athens Medical School

  STUDY DIRECTOR

Central Study Contacts

George Lazaros

CONTACT

glaz35@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Cardiologist

Study Record Dates

• First Submitted: April 20, 2016
• First Posted: April 28, 2016
• Study Start: September 1, 2009
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 28, 2016

Record last verified: 2016-04

Locations

GR (1)