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| Name | Class |
|---|---|
| Albertinen Krankenhaus | OTHER |
| Regio Kliniken | OTHER |
| Helios University Hospital Wuppertal | OTHER |
| Kreiskliniken Reutlingen |
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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with acute stroke in whom echocardiography is indicated will be studied by TTE and TEE.
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| Name | Affiliation | Role |
|---|---|---|
| Götz Thomalla, MD | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany | |||
| Albertinen-Krankenhaus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34496617 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Included | All patients with acute ischemic stroke and undetermined origin at study inclusion who were enrolled and planned to be studied with both TTE and TEE |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Included | All patients with acute ischemic stroke and undetermined origin at study inclusion who were enrolled and planned to be studied with both TTE and TEE |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Inpatient treatment on a stroke unit usually <7 days |
|
|
In-patient treatment on a stroke unit usually <7 days
Investigator recorded all events considered related to TTE or TEE
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients Receiving TTE | All patients with acute ischemic stroke and undetermined origin at study inclusion who were enrolled studied with TTE |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Götz Thomalla | University Medical Center Hamburg-Eppendorf | +4940501377410 | thomalla@uke.de |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 16, 2016 | Jan 26, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| OTHER |
| Klinikum Karlsbad-Langensteinbach | OTHER |
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| Hamburg |
| 22457 |
| Germany |
| Regio Klinikum Pinneberg | Pinneberg | 25421 | Germany |
| Kreiskliniken Reutlingen | Reutlingen | 72764 | Germany |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Diagnosis (acute ischemic stroke, transient ischemic attack, retinal ischemia) | Count of Participants | Participants |
|
|
| 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 | All patients studied with TTE and TEE | Posted | Count of Participants | Participants | Inpatient treatment on a stroke unit usually <7 days |
|
|
|
| 0 |
| 492 |
| 0 |
| 492 |
| 0 |
| 492 |
| EG001 | Patients Receiving TEE | All patients with acute ischemic stroke and undetermined origin at study inclusion who were enrolled studied with TEE | 0 | 454 | 0 | 454 | 0 | 454 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |