Comparative Effectiveness Study of Transthoracic and Transesophageal Echocardiography in Stroke

NCT ID: NCT03411642

Last Updated: 2023-09-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

494 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-01

Study Completion Date

2019-08-31

Brief Summary

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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

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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.

Conditions

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Stroke, Acute

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Albertinen Krankenhaus

OTHER

Sponsor Role collaborator

Regio Kliniken

OTHER

Sponsor Role collaborator

Helios University Hospital Wuppertal

OTHER

Sponsor Role collaborator

Kreiskliniken Reutlingen

OTHER

Sponsor Role collaborator

Klinikum Karlsbad-Langensteinbach

OTHER

Sponsor Role collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Götz Thomalla, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Locations

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Universitätsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Site Status

Albertinen-Krankenhaus

Hamburg, , Germany

Site Status

Regio Klinikum Pinneberg

Pinneberg, , Germany

Site Status

Kreiskliniken Reutlingen

Reutlingen, , Germany

Site Status

Countries

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Germany

References

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Thomalla G, Upneja M, Camen S, Jensen M, Schroder J, Barow E, Boskamp S, Ostermeier B, Kissling S, Leinisch E, Tiburtius C, Clausen H, Cheng B, Blankenberg S, Nedelmann M, Steinbrecher A, Andres F, Rosenkranz M, Sinning C, Schnabel RB, Gerloff C. Treatment-Relevant Findings in Transesophageal Echocardiography After Stroke: A Prospective Multicenter Cohort Study. Stroke. 2022 Jan;53(1):177-184. doi: 10.1161/STROKEAHA.121.034868. Epub 2021 Sep 9.

Reference Type DERIVED
PMID: 34496617 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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PV5225

Identifier Type: -

Identifier Source: org_study_id

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