University of Pittsburgh Medical Center - Presbyterian University Hospital
Pittsburgh, Pennsylvania, 15201, United States
NCT Number: NCT04128878
This is a prospective, observational study that will examine endothelial dysfunction in atrial fibrillation before and after treatment with anti-arrhythmic agents and the extent to which baseline endothelial dysfunction improves after treatment.
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Notify Me18 year–75 year
All sexes
Observational
Pittsburgh, Pennsylvania, 15201, United States
This will be a prospective, observational study and roughly 60 patients will be recruited based on strict inclusion/exclusion criteria. Goal population includes adult patients with a diagnosis of paroxysmal or persistent atrial fibrillation seen in the electrophysiology clinic and admitted to the UPMC Presbyterian electrophysiology service for initiation of anti-arrhythmic medications.
The primary goal of the study will be to evaluate the degree of endothelial function recovery seen after initiating anti-arrhythmic medical therapy. We will assess genetic markers, arterial stiffness and vasodilation in response to acetylcholine iontophoresis, nitroprusside iontophoresis, local thermal hyperemia and reactive hyperemia. Laser speckle contrast imaging will be employed to evaluate the microvasculature. SphygmoCor (arterial tonometry) will be used to assess macrovasculature. Testing will be performed at baseline prior to the 1st dose of anti- arrhythmic therapy and repeated again 1-3 months later at outpatient follow-up visit. Additionally, follow-up phone calls or office visits will take place at 6 and 12 months after the initial data collection visit to document recurrence rate of atrial fibrillation.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Exclusion criteria
will include:
The primary goal of the study will be to evaluate the change in endothelial function seen after initiating anti-arrhythmic medical therapy. Testing will be performed at baseline prior to the 1st dose of anti-arrhythmic therapy and again 1-3 months later at outpatient follow-up visit. We will record the resting flow (RF), biological zero (BZ) and peak flow (PF) as perfusion units (PU). Specifically, we will assess arterial stiffness and vasodilation in response to acetylcholine iontophoresis, nitroprusside iontophoresis, local thermal hyperemia and reactive hyperemia. Laser speckle contrast imaging will be employed to evaluate the microvasculature. SphygmoCor (arterial tonometry) will be used to assess macrovasculature.
Same as described above with sotalol.
Time frame: 1 year
Change in microvascular endothelium dependent dilation (in response to acetylcholine) assessed with laser speckle contrast imaging after initiating antiarrhythmic medical therapy.
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Samir Saba
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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