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NCT03223441 · ClinicalTrials.gov registry record
Pulse Wave Velocity as a Predictor for Postoperative Cardiovascular Events
A clinical trial of Arterial Stiffness and Post-Op Complication, sponsored by Kenichi Ueda.
- Completed
- Registry status
- 543
- Enrollment target
- 1
- Study location
NCT03223441: Completed study of Arterial Stiffness and Post-Op Complication, sponsored by Kenichi Ueda.
NCT03223441 is a study of Arterial Stiffness and Post-Op Complication that has completed, run by Kenichi Ueda. The registered enrollment target is 543 participants, above the 78-participant average among 12 other Arterial Stiffness trials with a reported enrollment target (596% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03223441, a study of Arterial Stiffness and Post-Op Complication, has completed, sponsored by Kenichi Ueda.
- COMPLETED
- Registry status
- 543 participants
- Enrollment target
- 1
- Study location
Study Summary
Vascular stiffness increases as a person ages, due to the repetitive stress that is put on the vascular system which causes changes in the elasticity of the vessel walls. The increased stiffness of the arteries puts added stress on the circulatory system. This rise in stiffness has been shown to be associated with an increased risk of cardiovascular events, in both presumably healthy patients, as well as elderly patients The current method for assessing perioperative cardiac risk is the Goldman's Revised Cardiac Risk Index (RCRI). This method, however, does not include a direct measurement of arterial stiffness. Applanation tonometry is a non-invasive technique that has been shown to reliably provide indices of arterial stiffness While the use of applanation tonometry has been widely studied in general medicine, it is has not been studied for pre-operative risk assessment in surgical patients. The purpose of this investigation is to examine whether aortic stiffness is an independent risk factor for developing cardiovascular related adverse events in patients who are having major surgery under general anesthesia. Applanation tonometry will be performed on the right carotid and femoral arteries to assess carotid-femoral pulse wave velocity, a surrogate for aortic stiffness. (SphygmoCor system, AtCor Medical, Sydney, Australia). The measurement will be obtained before induction of general anesthesia in the presurgical area. Patients' medical history, intraoperative hemodynamics, and any postoperative complications will be recorded to determine significant correlations and relationships. This information will potentially help identify future patients that might be at greater risk of developing an adverse cardiovascular event following their surgical procedure.
Primary Outcome
The study is aimed to compare arterial stiffness between patients who develop postoperative adverse cardiac complications and those who don't in patients who are undergoing major elective surgery. This includes coronary artery disease, congestive heart failure, cereberal artery disease, thrombolic event, carotid artery disease, kidney injury, valvular disease, significant EKG changes, respiratory failure and death. Arterial stiffness will be measured by pulse wave velocity (m/s) with a SphygmoCo
Conditions Studied
Study Locations (1)
Iowa
- University of Iowa Hospitals and Clinics - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 543 participants |
| Start Date | 2015-06 |
| Est. Completion | 2018-02 |
What the finished NCT03223441 record still lists
NCT03223441 is an observational study that tracks outcomes without assigning an intervention. The registered 543 participants enrollment target is mid-sized for trials with a published cap, above the 78-participant average among 12 other Arterial Stiffness trials with a reported enrollment target (596% higher).
The record links to 2 conditions, with Arterial Stiffness appearing as the primary indexed condition, and to 0 interventions.
NCT03223441 reports a single indexed study location in Iowa.
Frequently Asked Questions
What is clinical trial NCT03223441 about?
NCT03223441 is a clinical study titled "Pulse Wave Velocity as a Predictor for Postoperative Cardiovascular Events". Vascular stiffness increases as a person ages, due to the repetitive stress that is put on the vascular system which causes changes in the elasticity of the vessel walls. The increased stiffness of the arteries puts added stress on the circulatory system. This rise in stiffness has been shown to be ...
What is the current status of trial NCT03223441?
This trial is currently completed. The enrollment target is 543 participants. The study started on 2015-06. Estimated completion is 2018-02.
What conditions does trial NCT03223441 study?
This clinical trial studies the following conditions: Arterial Stiffness, Post-Op Complication.
Who is sponsoring clinical trial NCT03223441?
This trial is sponsored by Kenichi Ueda, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03223441 being conducted?
This trial has 1 study location across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03223441's enrollment target sits among peer trials
543 1st of 12 higher than 12 of 12 other Arterial Stiffness trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Arterial Stiffness 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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