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NCT03347032 · ClinicalTrials.gov registry record · NA
Remote Ischemic Preconditioning for Renal Protection in TAVI
A NA study of Aortic Valve Stenosis and Renal Insufficiency, sponsored by Henry Ford Health System.
- Completed
- Registry status
- NA
- Development phase
- 46
- Enrollment target
- 1
- Study location
NCT03347032: Completed NA study of Aortic Valve Stenosis and Renal Insufficiency, sponsored by Henry Ford Health System.
NCT03347032 is a NA study of Aortic Valve Stenosis and Renal Insufficiency that has completed, run by Henry Ford Health System. The registered enrollment target is 46 participants, below the 1,042-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03347032, a NA study of Aortic Valve Stenosis and Renal Insufficiency, has completed, sponsored by Henry Ford Health System.
- COMPLETED
- Registry status
- NA
- Development phase
- 46 participants
- Enrollment target
- 1
- Study location
Study Summary
Severe aortic stenosis remains a major cause of morbidity and mortality of the elderly affecting approximately 3% of elderly patients with an increasing number of patients undergoing transcatheter aortic valve interventions. As part of pre-procedural planning these patients undergo CT scans and receive contrast during the procedure. These patients often have baseline renal insufficiency and are high risk of contrast induced nephropathy despite pre-hydration techniques. The purpose of this study is to evaluate the efficacy of this simple and safe procedure in preventing renal injury in this particular population.
Primary Outcome
Assess the effects on post procedure renal injury. Lab work will be obtained in the form of a basic metabolic panel evaluating the creatinine level. A baseline basic metabolic panel will be obtained prior to scheduled procedure to evaluate baseline renal function and then 48-72 hours post procedure, the optimal time to see the effects of contrast induced nephropathy to evaluate the degree of acute kidney injury. The baseline and post procedure measurements of renal function will be compared betw
Conditions Studied
Interventions
- PROCEDURE Control
- PROCEDURE Remote ischemic preconditioning
Study Locations (1)
Michigan
- Henry Ford Hospital - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2018-02-13 |
| Est. Completion | 2018-12-30 |
| Phase | NA |
What the finished NCT03347032 record still lists
NCT03347032 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 1,042-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (96% lower).
The record links to 3 conditions, with Aortic Valve Stenosis appearing as the primary indexed condition, and to 2 interventions - of which Control is the first listed.
NCT03347032 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT03347032 about?
NCT03347032 is a clinical study titled "Remote Ischemic Preconditioning for Renal Protection in TAVI". Severe aortic stenosis remains a major cause of morbidity and mortality of the elderly affecting approximately 3% of elderly patients with an increasing number of patients undergoing transcatheter aortic valve interventions. As part of pre-procedural planning these patients undergo CT scans and rece...
What is the current status of trial NCT03347032?
This trial is currently completed. It is a NA study. The enrollment target is 46 participants. The study started on 2018-02-13. Estimated completion is 2018-12-30.
What conditions does trial NCT03347032 study?
This clinical trial studies the following conditions: Aortic Valve Stenosis, Renal Insufficiency, Contrast Induced Nephropathy.
What interventions are being tested in trial NCT03347032?
The interventions under investigation include: Control (PROCEDURE), Remote ischemic preconditioning (PROCEDURE).
Who is sponsoring clinical trial NCT03347032?
This trial is sponsored by Henry Ford Health System, which has 234 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03347032 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03347032's enrollment target sits among peer trials
46 27th of 30 higher than 3 of 30 other Aortic Valve Stenosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Aortic Valve Stenosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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