Stroke, Acute
Conditions
Keywords
Stroke, echocardiography
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.
Interventions
None listed
Sponsors
Albertinen Krankenhaus
Regio Kliniken
Helios University Hospital Wuppertal
Kreiskliniken Reutlingen
Klinikum Karlsbad-Langensteinbach
Universitätsklinikum Hamburg-Eppendorf
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Diagnostic Findings That Lead to a Change in Acute Treatment or Treatment for Secondary Prevention | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Change of Assessment of Stroke Etiology After TEE | 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 |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 494 |
| Total | 494 |
Baseline characteristics
| Characteristic | Patients Included | — |
|---|---|---|
| Age, Continuous | 64.7 years STANDARD_DEVIATION 13.3 | — |
| Diagnosis (acute ischemic stroke, transient ischemic attack, retinal ischemia) Acute ischemic stroke | 385 Participants | — |
| Diagnosis (acute ischemic stroke, transient ischemic attack, retinal ischemia) Retinal ischemia | 20 Participants | — |
| Diagnosis (acute ischemic stroke, transient ischemic attack, retinal ischemia) Transient ischemic attack | 89 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Germany | 494 participants | — |
| Sex: Female, Male Female | 204 Participants | — |
| Sex: Female, Male Male | 290 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 492 | 0 / 454 |
| other Total, other adverse events | 0 / 492 | 0 / 454 |
| serious Total, serious adverse events | 0 / 492 | 0 / 454 |
Outcome results
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.
Time frame: Inpatient treatment on a stroke unit usually <7 days
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Patients Studied With Both TTE and TEE | Number of Participants With Diagnostic Findings That Lead to a Change in Acute Treatment or Treatment for Secondary Prevention | Treatment relevant findings in TTE | No | 390 Participants |
| Patients Studied With Both TTE and TEE | Number of Participants With Diagnostic Findings That Lead to a Change in Acute Treatment or Treatment for Secondary Prevention | Treatment relevant findings in TEE | Yes | 86 Participants |
| Patients Studied With Both TTE and TEE | Number of Participants With Diagnostic Findings That Lead to a Change in Acute Treatment or Treatment for Secondary Prevention | Treatment relevant findings in TEE | No | 368 Participants |
| Patients Studied With Both TTE and TEE | Number of Participants With Diagnostic Findings That Lead to a Change in Acute Treatment or Treatment for Secondary Prevention | Treatment relevant findings in TTE | Yes | 64 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
Time frame: Inpatient treatment on a stroke unit usually <7 days
Population: All patients studied with TTE and TEE
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients Studied With Both TTE and TEE | Number of Patients With Change of Assessment of Stroke Etiology After TEE | Yes | 52 Participants |
| Patients Studied With Both TTE and TEE | Number of Patients With Change of Assessment of Stroke Etiology After TEE | No | 401 Participants |
| Patients Studied With Both TTE and TEE | Number of Patients With Change of Assessment of Stroke Etiology After TEE | Missing data | 1 Participants |