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NCT05362721 · ClinicalTrials.gov registry record
PV Loop & Coarctation Study
A clinical trial of Coarctation of Aorta, sponsored by University of Minnesota.
- Recruiting
- Registry status
- 20
- Enrollment target
- 7
- Study locations
NCT05362721: Recruiting study of Coarctation of Aorta, sponsored by University of Minnesota.
NCT05362721 is a study of Coarctation of Aorta that is actively recruiting participants, run by University of Minnesota. The registered enrollment target is 20 participants. The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05362721, a study of Coarctation of Aorta, is actively recruiting participants, sponsored by University of Minnesota.
- RECRUITING
- Registry status
- 20 participants
- Enrollment target
- 7
- Study locations
Study Summary
Coarctation of the aorta accounts for 4-7% of all congenital heart disease. While stent therapy, when feasible, is the standard of care for coarctation, it may not completely improve the work (and afterload) of the heart due to its effects on the elasticity of the aorta. This study will provide the information needed to understand the effects of current management on the cardiac mechanics and work.
Primary Outcome
Arterial elastance (Ea) is measured by the pressure volume (PV) loop catheter in the left ventricle. The PV loop catheter measures pressure and volume simultaneously during the entire cardiac cycle. Arterial elastance is a measure of ventricular afterload and will be calculated using previously described formula; Ea (arterial elastance): Ea = Pend systole/ SV (where P, is pressure at end systole, and SV is stroke volume). Elastance will be reported as a continuous variable in mmHg/mL with a h
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Pressure-volume loop catheter
Study Locations (7)
California
- Children's Hospital of Los Angeles - Los Angeles
Massachusetts
- Children's Hospital of Boston - Boston
Michigan
- Helen DeVos Children's Hospital - Grand Rapids
Minnesota
- University of Minnesota - Minneapolis
Missouri
- Children's Mercy Hospital - Kansas City
Ohio
- Cincinnati Children's Hospital - Cincinnati
Texas
- University of Texas-Southwestern - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2019-06-04 |
| Est. Completion | 2026-12-31 |
What NCT05362721 shows while recruiting
NCT05362721 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target.
The record links to 1 condition, with Coarctation of Aorta appearing as the primary indexed condition, and to 1 intervention - of which Pressure-volume loop catheter is the first listed.
NCT05362721 lists 7 locations in 7 states (California, Massachusetts, Michigan).
Frequently Asked Questions
What is clinical trial NCT05362721 about?
NCT05362721 is a clinical study titled "PV Loop & Coarctation Study". Coarctation of the aorta accounts for 4-7% of all congenital heart disease. While stent therapy, when feasible, is the standard of care for coarctation, it may not completely improve the work (and afterload) of the heart due to its effects on the elasticity of the aorta. This study will provide the ...
What is the current status of trial NCT05362721?
This trial is currently recruiting. The enrollment target is 20 participants. The study started on 2019-06-04. Estimated completion is 2026-12-31.
What conditions does trial NCT05362721 study?
This clinical trial studies the following conditions: Coarctation of Aorta.
What interventions are being tested in trial NCT05362721?
The interventions under investigation include: Pressure-volume loop catheter (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05362721?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05362721 being conducted?
This trial has 7 study locations across California, Massachusetts, Michigan, Minnesota, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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