Pericardial Effusion Clinical Trial
Official title:
A Trial of Complete Percutaneous Pericardial Drainage Facilitated by Intrapericardial Alteplase Compared to Conventional Pericardiocentesis When Indicated in Adults With Large Pericardial Effusion Due to Tuberculous and Non-tuberculous Pericarditis
The Second Investigation of the Management of Pericarditis (IMPI-2) Trial will compare the effectiveness and safety of complete percutaneous pericardial drainage facilitated by intrapericardial alteplase (recombinant human tissue-type plasminogen activator) to conventional pericardiocentesis when indicated in 2176 patients with large pericardial effusion due to tuberculous and non-tuberculous pericarditis. An internal pilot study of 218 patients will initially confirm the feasibility of conducting a large-scale multi-centre clinical trial of intrapericardial fibrinolysis in patients with large pericardial effusion, and also provide preliminary safety data, following a dose finding study of intrapericardial alteplase.
Intrapericardial fibrinolytic agents are used in the drainage of tuberculous, purulent,
neoplastic and other inflammatory pericardial effusions to prevent recurrent effusions and
constrictive pericarditis. This use is based on evidence from case reports and a small trial
that did not have the statistical power to reliably evaluate the effect of pericardial
drainage facilitated by intrapericardial fibrinolysis on safety and important clinical
outcomes.
The Second Investigation of the Management of Pericarditis (IMPI-2) Trial will compare the
effectiveness and safety of complete percutaneous pericardial drainage facilitated by
intrapericardial alteplase (recombinant human tissue-type plasminogen activator) to
conventional pericardiocentesis when indicated in 2176 patients with large pericardial
effusion due to tuberculous and non-tuberculous pericarditis. An internal pilot study of 218
patients will initially confirm the feasibility of conducting a large-scale multi-centre
clinical trial of intrapericardial fibrinolysis in patients with large pericardial effusion,
and also provide preliminary safety data, following a dose finding study of intrapericardial
alteplase.
Hypothesis: We hypothesise that patients with large pericardial effusion randomized to
intrapericardial alteplase to ensure complete pericardial drainage will have at least a 35%
reduction in cardiac tamponade requiring pericardiocentesis or constrictive pericarditis
compared to conventional pericardiocentesis when indicated.
Objectives: The primary objectives of the IMPI-2 Trial are:
1. To demonstrate the feasibility of conducting a multicentre clinical trial of
intrapericardial fibrinolysis in patients with large pericardial effusion, and to assess
the safety of intrapericardial alteplase in an internal pilot study, and
2. To determine the effectiveness of intrapericardial alteplase in reducing the composite
outcome of cardiac tamponade requiring pericardiocentesis or constrictive pericarditis
in patients with large pericardial effusion in the full trial.
Should the internal pilot study demonstrate feasibility and safety; all 218 patients will be
rolled-over into the full scale IMPI-2 trial of 2176 participants. The primary outcome is the
first occurrence of cardiac tamponade requiring pericardiocentesis or constrictive
pericarditis. The secondary safety endpoint is safety of intrapericardial fibrinolysis
measured by effect on major bleeding, and serious and non-serious adverse events. The
secondary efficacy outcomes are constrictive pericarditis, and cardiac tamponade requiring
pericardiocentesis, analysed separately, and persistent or recurrent pericardial effusion
without cardiac tamponade, hospitalisation, and death. The secondary diagnostic outcomes are
proportion with bacteriologically confirmed tuberculosis from any organ or tissue; time to
diagnosis of bacteriologically confirmed tuberculosis in days; accuracy of novel tests for
the diagnosis of tuberculosis; proportion with specific diagnosis of any pericardial disease;
time to diagnosis of a specific pericardial disease in days.
Study Design: IMPI-2 is a prospective randomized open blinded end-point trial that will
enroll 2176 patients with large pericardial effusion over 36 months from up to 30 centres in
South Africa and Africa. Eligible patients will be randomly assigned to receive complete
pericardial drainage facilitated by intrapericardial fibrinolysis or conventional
pericardiocentesis when indicated on enrollment to the study. Patients will be followed at 2
weeks, 6 weeks, 12 weeks, and in months 6, and 12 after enrollment. The IMPI Project Office,
University of Cape Town, South Africa will manage and coordinate the study in association
with the Pericarditis Research Unit, Walter Sisulu University, South Africa and the
Population Health Research Institute, McMaster University, Canada.
Importance: IMPI-2 addresses very serious complications of large pericardial effusion (i.e.,
cardiac tamponade and constrictive pericarditis), which are associated with high mortality
despite pericardiocentesis or pericardiectomy. This study will utilise the research network
that was established by the IMPI trial which was completed in 2014.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02045641 -
Pleural and Pericardial Effusion Following Open Heart Surgery
|
N/A | |
Completed |
NCT03327688 -
Point-of-care Ultrasound in Finland
|
N/A | |
Completed |
NCT02808897 -
Active Clearance of Chest Tubes After Cardiac Surgery: A Prospective Randomized Controlled Study
|
N/A | |
Not yet recruiting |
NCT06293924 -
Pericardial Fluid Analysis in Recurrent Pericarditis
|
||
Active, not recruiting |
NCT01552187 -
COlchicine for Prevention of the Post-pericardiotomy Syndrome and Post-operative Atrial Fibrillation (COPPS-2 Trial)
|
Phase 3 | |
Completed |
NCT00247052 -
Non Steroidal Anti Inflammatory Treatment for Post Operative Pericardial Effusion
|
Phase 4 | |
Completed |
NCT05061914 -
Surgical Options for Management of Pericardial Effusion
|
N/A | |
Completed |
NCT00684125 -
Evaluation of Different Strategies of Pericardial Drainage After Aortic Valvular Surgery
|
N/A | |
Completed |
NCT02260206 -
Impact of Colchicine Therapy on Arrhythmia Recurrence After Acute Pericardial Effusion
|
Phase 4 | |
Recruiting |
NCT05146492 -
Pericardial Effusion From Acute Myocardial Infarction: Contributing Factors and Prognosis at One Year (EPERICARDIM)
|
N/A | |
Active, not recruiting |
NCT05077111 -
A Comparative Study Between Regional Anesthesia in Thoracoscopes and the Conventional General Anesthesia
|
Phase 4 | |
Recruiting |
NCT01665495 -
Drainage or Pericardiocentesis (DROP) Alone for Recurrent Non-malignant Pericardial Effusions Requiring Intervention
|
N/A | |
Recruiting |
NCT04464655 -
A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
|
||
Recruiting |
NCT06159985 -
Effect of Left Posterior Pericardiotomy for the Prevention of POAF
|
N/A | |
Completed |
NCT01266694 -
Cochicine Treatment for Post- Operative Pericardial Effusion
|
Phase 4 | |
Recruiting |
NCT04279327 -
Cell Block Immunohistochemistry in Effusion Cytology
|
||
Completed |
NCT03887286 -
Focused Cardiac Ultrasound
|
N/A |