Efficacy of isoproterenol infusion for exclusion of left atrial appendage thrombus

JRCT ID: jRCTs031200261

Registered date:22/12/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Atrial fibrillation
• Date of first enrollment: 04/02/2021
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Isoprenaline hydrochloride injection 0.01-0.03 microgram / kg / min intravenously for up to 10 minutes

Outcome(s)

• Primary Outcome: Changes in the grade of spontaneous echo contrast in LA and LAA before and after isoprenaline infusion evaluated by the doctor performed TEE

Secondary Outcome

Changes 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 maximum: Not applicable
• Gender: Both

Include criteria

1)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 criteria

1) 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

• Primary Sponsor: Machino Tomoko
• Source(s) of Monetary Support: Japan society for the promotion of science