Trial Outcomes & Findings for Comparative Effectiveness Study of Transthoracic and Transesophageal Echocardiography in Stroke (NCT NCT03411642)

NCT ID: NCT03411642

Last Updated: 2023-09-13

Results Overview

Treatment relevant diagnostic findings identified by a central endpoint adjudication committee comprising both cardiologists and neurologists.

• Recruitment status: COMPLETED
• Target enrollment: 494 participants
• Primary outcome timeframe: Inpatient treatment on a stroke unit usually <7 days
• Results posted on: 2023-09-13

Participant Flow

Participant milestones

Measure	Patients Included All patients with acute ischemic stroke and undetermined origin at study inclusion who were enrolled and planned to be studied with both TTE and TEE
Overall Study STARTED	494
Overall Study Participants Who Received TTE	492
Overall Study Participants Who Received TEE	454
Overall Study COMPLETED	454
Overall Study NOT COMPLETED	40

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Patients Included n=494 Participants All patients with acute ischemic stroke and undetermined origin at study inclusion who were enrolled and planned to be studied with both TTE and TEE
Age, Continuous	64.7 years STANDARD_DEVIATION 13.3 • n=494 Participants
Sex: Female, Male Female	204 Participants n=494 Participants
Sex: Female, Male Male	290 Participants n=494 Participants
Region of Enrollment Germany	494 participants n=494 Participants
Diagnosis (acute ischemic stroke, transient ischemic attack, retinal ischemia) Acute ischemic stroke	385 Participants n=494 Participants
Diagnosis (acute ischemic stroke, transient ischemic attack, retinal ischemia) Transient ischemic attack	89 Participants n=494 Participants
Diagnosis (acute ischemic stroke, transient ischemic attack, retinal ischemia) Retinal ischemia	20 Participants n=494 Participants

PRIMARY outcome

Timeframe: Inpatient treatment on a stroke unit usually <7 days

Treatment relevant diagnostic findings identified by a central endpoint adjudication committee comprising both cardiologists and neurologists.

Outcome measures

Measure	Patients Studied With Both TTE and TEE n=454 Participants Patients studied with both TTE and TEE
Number of Participants With Diagnostic Findings That Lead to a Change in Acute Treatment or Treatment for Secondary Prevention Treatment relevant findings in TTE · Yes	64 Participants
Number of Participants With Diagnostic Findings That Lead to a Change in Acute Treatment or Treatment for Secondary Prevention Treatment relevant findings in TTE · No	390 Participants
Number of Participants With Diagnostic Findings That Lead to a Change in Acute Treatment or Treatment for Secondary Prevention Treatment relevant findings in TEE · Yes	86 Participants
Number of Participants With Diagnostic Findings That Lead to a Change in Acute Treatment or Treatment for Secondary Prevention Treatment relevant findings in TEE · No	368 Participants

SECONDARY outcome

Timeframe: Inpatient treatment on a stroke unit usually <7 days

Population: All patients studied with TTE and TEE

Number of patients with change in the assessment of stroke etiology (cardioembolism, large artery atherosclerosis, small vessel disease, other determined etiology, unknown etiology) after performing TEE

Outcome measures

Measure	Patients Studied With Both TTE and TEE n=454 Participants Patients studied with both TTE and TEE
Number of Patients With Change of Assessment of Stroke Etiology After TEE Yes	52 Participants
Number of Patients With Change of Assessment of Stroke Etiology After TEE No	401 Participants
Number of Patients With Change of Assessment of Stroke Etiology After TEE Missing data	1 Participants

Adverse Events

Patients Receiving TTE

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Patients Receiving TEE

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Dr. Götz Thomalla

University Medical Center Hamburg-Eppendorf

Phone: +4940501377410

Email: thomalla@uke.de

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place