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NCT02044471 · ClinicalTrials.gov registry record · NA
The IMPULSE Study: Pilot
A NA study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT02044471 is a NA study that has completed, run by Baylor College of Medicine. The registered enrollment target is 20 participants.
The verdict
NCT02044471, a NA study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study Summary
Continuous-flow (CF) left ventricular assist devices (LVADs) are an important tool in the treatment of end-stage heart failure, affording patients significantly improved quantity and quality of life. In recent years, tens of thousands of LVADs have been implanted worldwide, with nearly 1,000 at the Texas Heart Institute (THI). Despite the benefits from LVAD therapy, one major weakness is the high frequency of late strokes, reported up to 19%. CF LVADs minimize or remove the pulsatility within the blood system, introducing a new and incompletely understood physiology. Increased sympathetic ("fight or flight" nervous system) tone secondary to lack of pulse in the blood system can cause high blood pressure, with subsequent hemorrhaging strokes (bleeding into the brain) are one possible explanation for this high adverse event rate in CF LVAD patients. A simple intervention to decrease the increased sympathetic tone is called "ischemic conditioning"; a sphygmomanometer (blood pressure cuff) is placed on the patient's arm to compress a major artery (ischemia) with subsequent release of the cuff (reperfusion) for set periods of time. This has been shown to reduce blood pressure and major adverse cardiovascular events in other patient populations. We plan to conduct a trial to evaluate this intervention, ischemic conditioning, in patients with CF LVADs. We hypothesize that IC will cause a reduction in blood pressure and strokes in this patient population.
Interventions
- OTHER Remote Ischemic Conditioning (using Sphygmomanometer)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2014-08 |
| Est. Completion | 2016-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02044471
The ClinicalTrials.gov registry entry for NCT02044471 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Remote Ischemic Conditioning (using Sphygmomanometer) is the first listed.
NCT02044471 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02044471 about?
NCT02044471 is a clinical study titled "The IMPULSE Study: Pilot". Continuous-flow (CF) left ventricular assist devices (LVADs) are an important tool in the treatment of end-stage heart failure, affording patients significantly improved quantity and quality of life. In recent years, tens of thousands of LVADs have been implanted worldwide, with nearly 1,000 at the ...
What is the current status of trial NCT02044471?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2014-08. Estimated completion is 2016-12.
What interventions are being tested in trial NCT02044471?
The interventions under investigation include: Remote Ischemic Conditioning (using Sphygmomanometer) (OTHER).
Who is sponsoring clinical trial NCT02044471?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
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