Montefiore Medical Center
New York, 10470, United States
Location status: Recruiting
Location contact
Mario Garcia, MD
CONTACT
NCT Number: NCT04500899
The study proposes to develop a phenylephrine protocol to be used during transesophageal echocardiography, whereby intravenous phenylephrine would be used to increase afterload with the intent to mimic the awake hemodynamic profile and variation that occurs with normal physical activity. The expectation is to see changes in severity of Mitral Regurgitation (MR) grade with increasing afterload, which in turn can provide more accurate quantification of MR severity to assist in clinical decision making.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1 / Phase 2
New York, 10470, United States
Location status: Recruiting
Mario Garcia, MD
CONTACT
Routine echocardiography which is used to assess the severity of mitral regurgitation, sometimes underestimates the severity of mitral regurgitation, due to hemodynamic variations that occurs with normal physical activity and under the effect of sedation which is used to perform transesophageal echocardiography. By using phenylephrine during transesophageal echocardiography, the study intends to offset the hemodynamic variation that occurs with sedation and better assess the severity of mitral regurgitation, which would further assist in clinical decision-making regarding treatment. The goal of this study is to compare the severity of mitral regurgitation grade before and after the administration of phenylephrine during transesophageal echocardiography and to demonstrate a 25% increase in severity of mitral regurgitation grade compared to the baseline conditions, following the administration of phenylephrine.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A test dose of 20 mcg of Mydfrin will be administered through the peripheral intravenous line. BP will be monitored after each bolus of phenylephrine. Subsequent Mydfrin injections will then be administered in 50 mcg aliquots every 10-15 minutes, instead of 40 mcg, until the mean arterial blood pressure (MAP) increases by ≥ 20 mm Hg from the baseline MAP, however making sure not to exceed a MAP of 100 mmHg. Once a desired blood pressure has been achieved and maintained, echocardiographic evaluation of mitral regurgitation would be performed.
Other names: Phenylephrine
Time frame: Before and after phenylephrine administration during transesophageal echocardiography, approximately 40 minutes
The purpose of this study is to compare the echocardiographic parameters of MR grade before and after the use of phenylephrine during transesophageal echocardiography (TEE) and to document an increase in echocardiographic parameters of MR grade after the use of phenylephrine.
Contact information is provided by the study sponsor or research team.
Mario Garcia, MD
CONTACT
Waqas Hanif, MD
CONTACT
Montefiore Medical Center
Other
Evaluating the Severity of Mitral Regurgitation Using Phenylephrine During Transesophageal Echocardiography
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