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JAPANESE
国立保健医療科学院
JRCT ID: jRCTs031200261

Registered date:22/12/2020

Efficacy of isoproterenol infusion for exclusion of left atrial appendage thrombus

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedAtrial fibrillation
Date of first enrollment04/02/2021
Target sample size20
Countries of recruitment
Study typeInterventional
Intervention(s)Isoprenaline hydrochloride injection 0.01-0.03 microgram / kg / min intravenously for up to 10 minutes

Outcome(s)

Primary OutcomeChanges in the grade of spontaneous echo contrast in LA and LAA before and after isoprenaline infusion evaluated by the doctor performed TEE
Secondary OutcomeChanges in the grade of spontaneous echo contrast in LA and LAA before and after isoprenaline infusion evaluated by other independent investigator Changes in the LAA blood flow velocity, LAA wall motion velocity, left ventricular ejection fraction before and after isoprenaline infusion Number of cases for which the presence or absence of LAA thrombus could be diagnosed after isoprenaline infusion, and prevalence of LAA thrombus

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteria1)Patients with valvular or non-valvular atrial fibrillation (AF) 2)Patients undergoing transesophageal echocardiography (TEE) for evaluation of intracardiac thrombus before catheter ablation for AF, percutaneous left atrial appendage (LAA) occlusion, percutaneous mitral valve commissurotomy, and electrical cardioversion, or patients suspected cardiogenic stroke and undergoing TEE to evaluate intracardiac thrombus 3)Patients with a CHADS2 score of 1 or higher 4)Patients receiving anticoagulant therapy 5)Men and women over 20 years old 6)Patients with written informed consent 7)Patients with severe blood flow stasis (spontaneous echo contrast grade of 3 or 4) in left atrium (LA) and LAA
Exclude criteria1) Patients with past history of LAA occlusion or resection 2) Patients with sinus rhythm during TEE 3) Patients with obvious LAA thrombus without infusion of isoprenaline 4) Patients with systolic blood pressure of 80 mmHg or less or 180 mmHg or more before the start of TEE 5) Patients with heart rate (measured by the average method) of 100 bpm or more before the start of TEE 6) Patients with esophageal ulcer, esophageal varices, esophageal diverticulum, and high risk of esophageal injury or bleeding by TEE 7) Patients receiving catecholamines, ephedrine, methylephedrine, methylephedrine saccharinate, fenoterol, droxidopa 8) Patients with digitalis intoxication 9) Patients with hypertrophic cardiomyopathy who have significant obstruction with a maximum pressure gradient of 30 mmHg or more in the left ventricle 10) Patients with unstable angina 11) Patients with a history of Takotsubo cardiomyopathy 12) Patients with a history of hyperthyroidism 13) Patients with severe hypokalemia (serum potassium level <3.0 mEq / L) 14) Patients with disorientation, quadriplegia, dysarthria, and visual field impairment 15) Women who are pregnant or may become pregnant 16) Patients who are judged inappropriate by the researcher

Related Information

Contact

Public contact
Name Tomoko Machino
Address 1-1-1 Tennodai, Tsukuba Ibaraki Japan 305-8575
Telephone +81-29-853-3143
E-mail tomoko-machino@md.tsukuba.ac.jp
Affiliation University of Tsukuba
Scientific contact
Name Tomoko Machino
Address 2-1-1 Amakubo, Tsukuba Ibaraki Japan 305-8576
Telephone +81-298533143
E-mail tomoko-machino@md.tsukuba.ac.jp
Affiliation University of Tsukuba Hospital