Comparative Effectiveness Study of Transthoracic and Transesophageal Echocardiography in Stroke

Stroke, Acute Clinical Trial

— CONTEST  

Official title:

Comparative Effectiveness Study of Transthoracic and Transesophageal Echocardiography in Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03411642
• Other study ID #: PV5225
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: August 31, 2019

Study information

• Verified date: November 2022
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 494
• Est. completion date: August 31, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Locations

Country	Name	City	State
Germany	Albertinen-Krankenhaus	Hamburg
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg
Germany	Regio Klinikum Pinneberg	Pinneberg
Germany	Kreiskliniken Reutlingen	Reutlingen

Sponsors (6)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	Albertinen-Krankenhaus Hamburg, Helios University Hospital Wuppertal, Klinikum Karlsbad-Langensteinbach, Kreiskliniken Reutlingen, Regio Klinikum Pinneberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Diagnostic Findings That Lead to a Change in Acute Treatment or Treatment for Secondary Prevention	Treatment relevant diagnostic findings identified by a central endpoint adjudication committee comprising both cardiologists and neurologists.	Inpatient treatment on a stroke unit usually <7 days
Secondary	Number of Patients With Change of Assessment of Stroke Etiology After 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	Inpatient treatment on a stroke unit usually <7 days