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| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Non-Randomized; Endpoint Classification: Pharmacokinetics Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Diagnostic |
| Conditions: |
Arrhythmia Atrial Fibrillation Atrial Flutter |
| Intervention: |
Procedure: Fat tissue needle aspiration |
Participant Flow
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| Recruitment at a teaching hospital, from July 2006 to October 2007. |
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| 67 consecutive patients were evaluated and 30 patients included. Reasons for non inclusion were: impossible to retrace history of amiodarone administration: 19 patients; less than 3 months on amiodarone treatment: 10 patients; unable to give informed consent: 4 patients; refused to participate: 4 patients. |
| Description | |
|---|---|
| Amiodarone/Fat Tissue Needle Aspiration | Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings |
| Amiodarone/Fat Tissue Needle Aspiration | |
|---|---|
| STARTED | 30 |
| COMPLETED | 30 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Description | |
|---|---|
| Amiodarone/Fat Tissue Needle Aspiration | Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings |
| Amiodarone/Fat Tissue Needle Aspiration | |
|---|---|
|
Number of Participants
[units: participants] |
30 |
|
Age
[units: participants] |
|
| <=18 years | 0 |
| Between 18 and 65 years | 6 |
| >=65 years | 24 |
|
Age
[units: years] Mean ± Standard Deviation |
75 ± 14 |
|
Gender
[units: participants] |
|
| Female | 11 |
| Male | 19 |
|
Region of Enrollment
[units: participants] |
|
| France | 30 |
Outcome Measures
| 1. Primary: | Relationship Between Amiodarone Concentration in Fat Tissue and Cumulated Dose. [ Time Frame: One single measure ] |
| 2. Primary: | Relationship Between Amiodarone Concentrations in Fat Tissue and in Plasma. [ Time Frame: One single measure, taken just before daily administration ] |
| 3. Primary: | Relationship Between Amiodarone Concentrations in Fat Tissue and Developing Adverse Effects. [ Time Frame: Cumulated time on amiodarone (varies in each patient) ] |
| 4. Secondary: | Pain and Complications (if Any) Caused by Fat Tissue Needle Aspirations [ Time Frame: 24 hours after needle aspiration ] |
| 5. Secondary: | Presence of Any Adverse Effect Attributable to Amiodarone. [ Time Frame: Cumulated time on amiodarone (varies in each patient) ] |
More Information
| Principal Investigators are NOT employed by the organization sponsoring the study. |
| There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. |
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| Small number of patients included. High variability of amiodarone concentrations in fat tissue between the 2 simultaneous samples for some patients. Incidence of amiodarone-related adverse effects probably overestimated. |
| Responsible Party: | Dr Carmelo Lafuente-Lafuente, Unité de Recherches Therapeutiques. Hopital Lariboisiere. |
| ClinicalTrials.gov Identifier: | NCT00313443 History of Changes |
| Other Study ID Numbers: | ATACA-URT04/06 |
| Study First Received: | April 10, 2006 |
| Results First Received: | June 18, 2009 |
| Last Updated: | July 6, 2011 |
| Health Authority: | France: Ministry of Health |
