An observational study in Stroke, Acute, sponsored by Universitätsklinikum Hamburg-Eppendorf. Completed at 4 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-13.
Sponsored by Universitätsklinikum Hamburg-Eppendorf · Observational
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.
Patients with acute stroke in whom echocardiography is indicated will be studied by TTE and TEE.
Exclusion Criteria:
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
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
| Milestone | Patients Included |
|---|---|
| Started | 494 |
| Participants who received tte | 492 |
| Participants who received tee | 454 |
| Completed | 454 |
| Not completed | 40 |
Treatment relevant diagnostic findings identified by a central endpoint adjudication committee comprising both cardiologists and neurologists.
| Participants | Patients Studied With Both TTE and TEE |
|---|---|
| Treatment relevant findings in TTE — Yes | 64 |
| Treatment relevant findings in TTE — No | 390 |
| Treatment relevant findings in TEE — Yes | 86 |
| Treatment relevant findings in TEE — No | 368 |
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
| Participants | Patients Studied With Both TTE and TEE |
|---|---|
| Yes | 52 |
| No | 401 |
| Missing data | 1 |
Collected over In-patient treatment on a stroke unit usually <7 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patients Receiving TTE | 0/492 (0%) | 0/492 (0%) | 0/492 (0%) |
| Patients Receiving TEE | 0/454 (0%) | 0/454 (0%) | 0/454 (0%) |
| Age, Continuous(years) | Patients Included |
|---|---|
| Mean | 64.7 ± 13.3 |
| Sex: Female, Male(Participants) | Patients Included |
|---|---|
| Female | 204 |
| Male | 290 |
| Race and Ethnicity Not Collected(Participants) | Patients Included |
|---|
| Region of Enrollment(participants) | Patients Included |
|---|---|
| Germany | 494 |
| Diagnosis (acute ischemic stroke, transient ischemic attack, retinal ischemia)(Participants) | Patients Included |
|---|---|
| Acute ischemic stroke | 385 |
| Transient ischemic attack | 89 |
| Retinal ischemia | 20 |
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Universitätsklinikum Hamburg-Eppendorf