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NCT Number: NCT03411642

Comparative Effectiveness Study of Transthoracic and Transesophageal Echocardiography in Stroke

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.

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Key information

Conditions

Stroke, Acute Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Albertinen-Krankenhaus, Hamburg, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Collaborators

  • Albertinen Krankenhaus
  • Helios University Hospital Wuppertal
  • Klinikum Karlsbad-Langensteinbach
  • Kreiskliniken Reutlingen
  • Regio Kliniken

Registry information

Acronym: CONTEST

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 26, 2018
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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