Clinical Trial: Prognostic Biomarkers in Patients With Acute Pericarditis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Prognostic Biomarkers in Patients With Acute Pericarditis

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.


Detailed Summary:

Background: Acute pericarditis is a relatively common disorder with a reported incidence ranging from 3.32 to 27.7 cases per 100,000 persons per year in the Western word.Potential complications of acute pericarditis include pericarditis recurrence, cardiac tamponade and constrictive pericarditis.To date there is limited clinical evidence on prognostic factors of outcome in acute pericarditis; use of steroids/colchicine, the kinetics of C-reactive protein (CRP) in the acute phase and the underlying aetiology have been previously associated with recurrence of acute pericarditis. Nevertheless there are currently no established biomarkers to risk stratify patients with acute pericarditis.

Methods:

This will be a prospective observational study in three hundred (n=300) patients with a first diagnosis of acute pericarditis to explore the value of plasma or imaging biomarkers in predicting clinical outcome.

Written informed consent will be obtained obtained from all patients. The protocol has been approved by the Institutional Ethics Committee (ref. number 14167/20/08/2009) and will be carried out in accordance with the principles of the declaration of Helsinki.

Diagnosis of acute pericarditis and choice of treatment Acute pericarditis was diagnosed based on clinical recommendations. Baseline clinical and demographic data were recorded in all cases. In line with the current guidelines, diagnostic work-up included clinical history and examination, ECG, chest x-ray, echocardiography and routine blood tests including among others high-sensitivity cardiac troponin I and CRP.12 In patients with high risk features for secondary forms or complicated course13 additional tests will be performed at the discretion of the attending physician.<
Sponsor: Hippocration General Hospital

Current Primary Outcome: Development of of constrictive, recurrent or incessant pericarditis or poor response to NSAIDs treatment. [ Time Frame: Up to 18 months after hospital discharge ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Development of new atrial fibrillation [ Time Frame: Development of new atrial fibrillation at 7 days. ]

Patients will be monitored by daily ECGs up to 1 week for the development of new atrial fibrillation


Original Secondary Outcome: Same as current

Information By: Hippocration General Hospital

Dates:
Date Received: April 20, 2016
Date Started: September 2009
Date Completion: December 2025
Last Updated: April 25, 2016
Last Verified: April 2016