Comparative Effectiveness Study of Transthoracic and Transesophageal Echocardiography in Stroke

Completed

• Conditions: Stroke, Acute

• Registration Number: NCT03411642
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief Summary

The Comparative Effectiveness Study of Transthoracic and Transesophageal Echocardiography in Stroke (CONTEST) aims at assessing the diagnostic value of transesophageal echocardiography (TEE) and transthoracic echocardiography (TTE) with regards to treatment consequences in patients with acute ischemic stroke.

Detailed Description

For this purpose, the investigators will perform a prospective multicenter diagnostic comparative effectiveness study. Patients with acute stroke will be studied by both TTE and TEE. Patients with already defined stroke etiology and determined secondary prevention will be excluded from the trial. Treatment relevant diagnostic findings will be identified by a central endpoint adjudication committee. In order to demonstrate a hypothesized 2% absolute increase in the number of treatment relevant diagnostic findings by TEE as compared to TTE, 880 stroke patients will be enrolled in six German stroke centers. CONTEST will allow answering the question whether and for which group of stroke patients TEE is indicated in addition to TTE. By this, the study will provide evidence to guide justified recommendations for echocardiography in acute stroke patients.

Study Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2018-01-19
• Study First Submitted QC: 2018-01-25
• Study First Posted: 2018-01-26
• Primary Completion: 2019-06-30
• Study Completion: 2019-08-31
• Results First Submitted: 2021-10-03
• Status Verified: 2022-11
• Results First Submitted QC: 2022-11-06
• Last Update Submitted: 2022-11-06
• Results First Posted: 2023-09-13
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 494

Inclusion Criteria

• acute ischemic stroke or transitory ischemic attack (TIA)
• age ≥18 years
• informed consent

Exclusion Criteria

• Patients with already defined stroke etiology and determined secondary prevention treatment strategy prior to echocardiography (e.g. atrial fibrillation, carotid artery stenosis, cervical artery dissection)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With Diagnostic Findings That Lead to a Change in Acute Treatment or Treatment for Secondary Prevention	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.

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Change of Assessment of Stroke Etiology After TEE	Inpatient treatment on a stroke unit usually <7 days	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

Trial Locations

Locations (4)

Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

Albertinen-Krankenhaus; 🇩🇪 Hamburg, Germany

Regio Klinikum Pinneberg; 🇩🇪 Pinneberg, Germany

Kreiskliniken Reutlingen; 🇩🇪 Reutlingen, Germany