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Impact of Colchicine Therapy on Arrhythmia Recurrence After Acute Pericardial Effusion

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ClinicalTrials.gov Identifier: NCT02260206
Recruitment Status : Unknown
Verified April 2019 by Yong Seog Oh, Seoul St. Mary's Hospital.
Recruitment status was:  Recruiting
First Posted : October 9, 2014
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Yong Seog Oh, Seoul St. Mary's Hospital

Brief Summary:
The effects colchicine administration for acute pericardial effusion after radiofrequency catheter ablation (RFCA) of atrial fibrillation on the recurrences of arrhythmia.

Condition or disease Intervention/treatment Phase
Pericardial Effusion Drug: Colchicine Phase 4

Detailed Description:
RFCA was started as a rhythm control of atrial fibrillation about 10 years before and the superiority of RFCA to medical treatment has been continuously reporting, so RFCA is globally performed nowadays. Acute pericardial effusion could occur during RFCA as complication, that might be developed to cardiac tamponade needed immediate pericardiocentesis. The inflammation developed after pericardiocentesis might be associated with the recurrences of atrial fibrillation, it could be presumed by the frequent occurrence of atrial fibrillation after open-heart surgery. The inflammation can be suppressed by administration of colchicine and the effects of colchicine have been proven to decrease the development of atrial fibrillation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Impact of Colchicine Therapy on Arrhythmia Recurrence After Acute Pericardial Effusion Following Catheter Ablation of Atrial Fibrillation
Study Start Date : July 2014
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Colchicine

Arm Intervention/treatment
Experimental: Colchicine
Impact of Colchicine therapy on arrhythmia Recurrence after Acute Pericardial Effusion following Catheter Ablation of Atrial Fibrillation
Drug: Colchicine
Impact of Colchicine therapy on arrhythmia Recurrence after Acute Pericardial Effusion following Catheter Ablation of Atrial Fibrillation
Other Name: Impact of Colchicine

No Intervention: No intervention
No intervention



Primary Outcome Measures :
  1. recurrence of atrial arrhythimia [ Time Frame: 1 year after colchicines administration ]
    Assessment of the recurrence of atrial arrhythimia 1 year after colchicines administration


Secondary Outcome Measures :
  1. recurrence of atrial arrhythimia [ Time Frame: 3 year after colchicines administration ]
    Assessment of the recurrence of atrial arrhythimia 3 year after colchicines administration



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients needed to pericardiocentesis during RFCA for paroxysmal or persistent atrial fibrillation.

Exclusion Criteria:

  • Hypersensitivity on Colchicine
  • The existence of intra-cardiac thrombus on trans-esophageal echocardiography
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02260206


Contacts
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Contact: Sung Hwan Kim, professor 82-2-2258-1141 sunghwan@catholic.ac.kr

Locations
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Korea, Republic of
Seoul St Mary's Hospital Recruiting
Seoul, Seo Cho Gu, Korea, Republic of, 137-701
Contact: In Ae Jung, coordinator         
Sponsors and Collaborators
Yong Seog Oh
Investigators
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Principal Investigator: Yong Seog Oh, MD Seoul St. Mary's Hospital
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Responsible Party: Yong Seog Oh, MD, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT02260206    
Other Study ID Numbers: colchicine
First Posted: October 9, 2014    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Yong Seog Oh, Seoul St. Mary's Hospital:
Pericardial Effusion
Colchicine
arrhythmia Recurrence
pericardiocentesis
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Pericardial Effusion
Recurrence
Disease Attributes
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents