Comparative Effectiveness Study of Transthoracic and Transesophageal Echocardiography in Stroke (CONTEST)

November 6, 2022 updated by: Universitätsklinikum Hamburg-Eppendorf
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

494

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg-Eppendorf
      • Hamburg, Germany, 22457
        • Albertinen-Krankenhaus
      • Pinneberg, Germany, 25421
        • Regio Klinikum Pinneberg
      • Reutlingen, Germany, 72764
        • Kreiskliniken Reutlingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with acute stroke in whom echocardiography is indicated will be studied by TTE and TEE.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Diagnostic Findings That Lead to a Change in Acute Treatment or Treatment for Secondary Prevention
Time Frame: 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.
Inpatient treatment on a stroke unit usually <7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients With Change of Assessment of Stroke Etiology After TEE
Time Frame: 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
Inpatient treatment on a stroke unit usually <7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Collaborators

Kreiskliniken Reutlingen
Helios University Hospital Wuppertal
Klinikum Karlsbad-Langensteinbach
Albertinen-Krankenhaus Hamburg
Regio Klinikum Pinneberg

Investigators

  • Principal Investigator: Götz Thomalla, MD, Universitätsklinikum Hamburg-Eppendorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

August 31, 2019

Study Registration Dates

First Submitted

January 19, 2018

First Submitted That Met QC Criteria

January 25, 2018

First Posted (Actual)

January 26, 2018

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

November 6, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PV5225

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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