PV Loop & Coarctation Study
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|ClinicalTrials.gov Identifier: NCT05362721|
Recruitment Status : Recruiting
First Posted : May 5, 2022
Last Update Posted : May 5, 2022
|Condition or disease||Intervention/treatment|
|Coarctation of Aorta||Diagnostic Test: Pressure-volume loop catheter|
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||Assessment of the Impact of Transcatheter Stenting of Aortic Coarctation on the Left Ventricular Afterload and Work Using Left Ventricular Pressure Volume Loops|
|Actual Study Start Date :||June 4, 2019|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||December 31, 2023|
|Pressure-volume loop catheter||
Diagnostic Test: Pressure-volume loop catheter
The cardiac catheterization procedure will be done according to standard protocol as part of the standard clinical care. This has become the standard of care in any patient in which it feasible and is performed with low risk.
- Change in left ventricular afterload measured by arterial elastance [ Time Frame: Immediately following intervention ]
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 higher number indicating an increase in elastance and a negative number indicating a decrease in elastance. Change in elastance before and after stent placement will be compared using paired T test.
- Change in left ventricular performance measured by ESPVR [ Time Frame: Immediately following intervention ]The end systolic pressure volume relationship (ESPVR) summarizes ventricular systolic function and is measured as a slope of End systolic ventricular elastance (Ees) and volume-axis intercept Vo such that ESP = Ees (ESV-Vo) (ESP = end-systolic pressure, ESV = end-systolic volume, Vo represents the unstressed volume, which is the volume required to fill the ventricle before pressure rises). Shifts of the ESPVR occur with changes in ventricular contractility such that increases in contractility are associated with upward/leftward shifts of the ESPVR. ESPVR is obtained by analysing the data and PV loops obtained by PV loop catheter in the left ventricle before and after intervention. It will be depicted as a continuous variable in mmHg/ml as well as graphically as a slope. Changes before and after intervention will be compared as shifts in ESPVR.
- Change in left ventricular work as measured by Stroke Work [ Time Frame: Immediately following intervention ]Stroke work (SW) is a continuous variable that measures the work done by the left ventricle in ejecting blood in one cardiac cycle. It is the area under one loop and is measured in mmHg.ml. SW is obtained by analysing the data and PV loops obtained by PV loop catheter in the left ventricle before and after intervention. SW before and after intervention will be compared as continuous variables using appropriate statistical tests.
- Change in left ventricular efficiency as measured by ventricular arterial coupling [ Time Frame: Immediately following intervention ]VA coupling is calculated by the ratio of effective arterial elastance (Ea), a measure of afterload, to LV endsystolic elastance (Ees), a relatively load independent measure of LV chamber performance. Both these measures are expressed in mmHg/ml and as continuous variables. Normal determined Ea and Ees values in resting subjects are 2.2 ± 0.8 mmHg/ml and 2.3 ± 1.0 mmHg/ml, respectively. When Ea/Ees ratio is approximately equal to 1.0, LV and arterial system are optimally coupled to produce stroke work, a measure of the efficiency of LV work, corresponding to the product of systolic arterial pressure and stroke volume, and related to oxygen consumption. When Ea/Ees ratio is <1.0, the stroke work remains close to optimal values, but when EA/EES ratio is >1.0, the stroke work significantly falls, and the LV becomes progressively less efficient. We will compare VA coupling before and after intervention and will be analyzed as continuous variables with appropriate statistical tests.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05362721
|Contact: Brittany Faanesfirstname.lastname@example.org|
|United States, Massachusetts|
|Children's Hospital of Boston||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Ryan Callahan, MD 617-355-2079 email@example.com|
|United States, Michigan|
|Helen DeVos Children's Hospital||Recruiting|
|Grand Rapids, Michigan, United States, 49503|
|Contact: Oliver Aregullin, MD 616-267-9150 firstname.lastname@example.org|
|United States, Minnesota|
|University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Brittany Faanes 612-625-5929 email@example.com|
|Principal Investigator: Gurumurthy Hiremath, MD|
|United States, Missouri|
|Children's Mercy Hospital||Recruiting|
|Kansas City, Missouri, United States, 64108|
|Contact: Toby Rockefeller, MD firstname.lastname@example.org|
|United States, Ohio|
|Cincinnati Children's Hospital||Recruiting|
|Cincinnati, Ohio, United States, 45229|
|Contact: Sarosh (Shawn) Batlivala, MD 513-636-4432 email@example.com|
|Principal Investigator:||Gurumurthy Hiremath||University of Minnesota|