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NCT02898337 · ClinicalTrials.gov registry record
Methadone-Induced QT Interval Prolongation in a Narcotic Treatment Center
A clinical trial, sponsored by Indiana University.
- Completed
- Registry status
- 170
- Enrollment target
NCT02898337 is a clinical trial that has completed, run by Indiana University. The registered enrollment target is 170 participants.
The verdict
NCT02898337 has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- 170 participants
- Enrollment target
Study Summary
Torsades de pointes (TdP) is a polymorphic ventricular tachycardia associated with prolongation of the heart rate-corrected QT (QTc) interval on the electrocardiogram (ECG). TdP can result in catastrophic outcomes, including sudden cardiac death. QTc interval prolongation is a well-known adverse event associated with methadone use. While some risk factors for methadone-associated QTc interval prolongation and TdP have been identified, the contribution of interacting drugs and concomitant administration of other QTc interval-prolonging agents to overall risk has not been determined. The effect of ECG screening and monitoring on clinical outcomes in patients taking methadone has not been evaluated, and clinical opinion regarding routine ECG and risk factor monitoring varies. Twelve lead ECGs are costly and time-intensive for clinic staff. ECG screening in selected patients based on presence of QTc interval risk factors, rather than broadly in all patients taking methadone, would facilitate more targeted, strategic QTc interval monitoring. The FDA-approved AliveCor® handheld smart phone/tablet device records a single lead ECG (iECG) within 30 seconds. Use of this device may facilitate simpler, more rapid and less costly ECG monitoring in patients receiving care in narcotic treatment centers. Our long-term goals are to determine mechanisms by which drugs cause arrhythmias, to identify patients at greatest risk of drug-induced arrhythmias, and to determine safe and effective methods for prevention and management of drug-induced arrhythmias. Specific Aim 1: Identify independent risk factors for methadone-induced QTc interval prolongation in patients undergoing care in a narcotic treatment center. Research Design: This will be a retrospective/prospective analysis of ECGs and health information from patients receiving methadone therapy in the Eskenazi Health Midtown Narcotic Treatment Center in Indianapolis, IN. Currently, at the Midtown Narcotic Treatment Center, baseli
Interventions
- DEVICE AliveCor handheld mobile ECG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 170 participants |
| Start Date | 2016-11 |
| Est. Completion | 2018-05-22 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02898337
The ClinicalTrials.gov registry entry for NCT02898337 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 170 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which AliveCor handheld mobile ECG is the first listed.
NCT02898337 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02898337 about?
NCT02898337 is a clinical study titled "Methadone-Induced QT Interval Prolongation in a Narcotic Treatment Center". Torsades de pointes (TdP) is a polymorphic ventricular tachycardia associated with prolongation of the heart rate-corrected QT (QTc) interval on the electrocardiogram (ECG). TdP can result in catastrophic outcomes, including sudden cardiac death. QTc interval prolongation is a well-known adverse eve...
What is the current status of trial NCT02898337?
This trial is currently completed. The enrollment target is 170 participants. The study started on 2016-11. Estimated completion is 2018-05-22.
What interventions are being tested in trial NCT02898337?
The interventions under investigation include: AliveCor handheld mobile ECG (DEVICE).
Who is sponsoring clinical trial NCT02898337?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
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