Clinical trial NCT03411642: Comparative Effectiveness Study of Transthoracic and Transesophageal Echocardiography in Stroke
Official title: Comparative Effectiveness Study of Transthoracic and Transesophageal Echocardiography in Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke, Acute
Keywords: Stroke, echocardiography
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: Albertinen Krankenhaus
name: Regio Kliniken
name: Helios University Hospital Wuppertal
name: Kreiskliniken Reutlingen
name: Klinikum Karlsbad-Langensteinbach
First posted: 2018-01-26
Enrollment: 494
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute stroke in whom echocardiography is indicated will be studied by TTE and TEE.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of Participants With Diagnostic Findings That Lead to a Change in Acute Treatment or Treatment for Secondary Prevention
timeFrame: Inpatient treatment on a stroke unit usually <7 days
Secondary outcomes:
measure: Number of Patients With Change of Assessment of Stroke Etiology After TEE
timeFrame: Inpatient treatment on a stroke unit usually <7 days
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Hamburg
country: Germany
facility: Albertinen-Krankenhaus
city: Pinneberg
country: Germany
facility: Regio Klinikum Pinneberg
city: Reutlingen
country: Germany
facility: Kreiskliniken Reutlingen
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Götz Thomalla, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.