Pericardial EffusionPhase 4NCT02260206
Impact of Colchicine Therapy on Arrhythmia Recurrence After Acute Pericardial Effusion
A Phase 4 study testing Colchicine in people with Pericardial Effusion, run by Yong Seog Oh at 1 site in South Korea.
Trial summary
The effects colchicine administration for acute pericardial effusion after radiofrequency catheter ablation (RFCA) of atrial fibrillation on the recurrences of arrhythmia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pericardial Effusion
- What is being tested?
- Colchicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2014to Oct 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients needed to pericardiocentesis during RFCA for paroxysmal or persistent atrial fibrillation.
Who cannot join
- Hypersensitivity on Colchicine
- The existence of intra-cardiac thrombus on trans-esophageal echocardiography
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Colchicine Therapy on Arrhythmia Recurrence After Acute Pericardial Effusion Following Catheter Ablation of Atrial Fibrillation
The effects colchicine administration for acute pericardial effusion after radiofrequency catheter ablation (RFCA) of atrial fibrillation on the recurrences of arrhythmia.
Read the 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.
- Conditions
- Pericardial Effusion
- Being tested
- Colchicine
- Keywords
- Pericardial Effusion, Colchicine, arrhythmia Recurrence, pericardiocentesis
- Medical subject headings
- Pericardial Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
Also called Impact of Colchicine
Impact of Colchicine therapy on arrhythmia Recurrence after Acute Pericardial Effusion following Catheter Ablation of Atrial Fibrillation
| Study group | Role | What they receive |
|---|---|---|
| Colchicine | Experimental | Impact of Colchicine therapy on arrhythmia Recurrence after Acute Pericardial Effusion following Catheter Ablation of Atrial Fibrillation Receives: Drug: Colchicine |
| No intervention | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence of atrial arrhythimia
Assessment of the recurrence of atrial arrhythimia 1 year after colchicines administration
Measured: 1 year after colchicines administration
Secondary outcomes (1)
recurrence of atrial arrhythimia
Assessment of the recurrence of atrial arrhythimia 3 year after colchicines administration
Measured: 3 year after colchicines administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2014 (estimated)
- Study startJul 2014
- Primary completionSep 2019
- Study completionOct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pericardial EffusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- None (Open label)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yong Seog Oh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yong Seog Oh, Seoul St. Mary's Hospital
- Investigators
- Yong Seog Oh, MD, Principal investigator, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02260206
- Sponsor's protocol ID
- colchicine
- Status last verified
- Apr 2024
- First submitted
- 5 Oct 2014
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Colchicine Therapy on Arrhythmia Recurrence After Acute Pericardial Effusion Following Catheter Ablation of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02260206
- Acronym / sponsor ID
- colchicine
- Conditions
- Pericardial Effusion
- Keywords
- Pericardial Effusion, Colchicine, arrhythmia Recurrence, pericardiocentesis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Yong Seog OhUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Sep 2019 (actual)
- Study completion
- Oct 2023 (actual)
- First posted
- 9 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The effects colchicine administration for acute pericardial effusion after radiofrequency catheter ablation (RFCA) of atrial fibrillation on the recurrences of arrhythmia.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- None (Open label)
| Arm | Type | Receives |
|---|---|---|
| Colchicine | Experimental | Drug: ColchicineImpact of Colchicine therapy on arrhythmia Recurrence after Acute Pericardial Effusion following Catheter Ablation of Atrial Fibrillation |
| No intervention | No intervention | –No intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients needed to pericardiocentesis during RFCA for paroxysmal or persistent atrial fibrillation.
Key exclusion criteria (3 listed)
- Hypersensitivity on Colchicine
- The existence of intra-cardiac thrombus on trans-esophageal echocardiography
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColchicineAlso: Impact of ColchicineImpact of Colchicine therapy on arrhythmia Recurrence after Acute Pericardial Effusion following Catheter Ablation of Atrial Fibrillation | Drug | Colchicine |
Primary outcome
recurrence of atrial arrhythimia
Time frame: 1 year after colchicines administration
Assessment of the recurrence of atrial arrhythimia 1 year after colchicines administration
1 secondary outcome
recurrence of atrial arrhythimia
Time frame: 3 year after colchicines administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yong Seog Oh, MD principal investigator
Seoul St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Colchicine in people with Pericardial Effusion, run by Yong Seog Oh at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence of atrial arrhythimia (time frame: 1 year after colchicines administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.