Stroke, AcuteCONTESTNCT03411642

Comparative Effectiveness Study of Transthoracic and Transesophageal Echocardiography in Stroke

An observational study of Stroke, Acute, run by Universitätsklinikum Hamburg-Eppendorf at 4 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Stroke, Acute
How many people: 494 participants
Where: 4 sitesGermany
Study dates: 1 Jul 2017to 31 Aug 2019
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients with acute stroke in whom echocardiography is indicated will be studied by TTE and TEE.

Who may be able to join

acute ischemic stroke or transitory ischemic attack (TIA)
age ≥18 years
informed consent

Who cannot join

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)

Trial locations and contacts

4 sites in 1 country.

Germany4 sites

Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
Albertinen-Krankenhaus
Hamburg, 22457
Regio Klinikum Pinneberg
Pinneberg, 25421
Kreiskliniken Reutlingen
Reutlingen, 72764

Other trials in Germany

About this study

Read the 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.

Conditions: Stroke, Acute
Keywords: Stroke, echocardiography
Medical subject headings: Stroke

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Inpatient treatment on a stroke unit usually <7 days

Secondary outcomes (1)

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
Measured: Inpatient treatment on a stroke unit usually <7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 201731 Aug 2019

First posted26 Jan 2018
Study start1 Jul 2017
Primary completion30 Jun 2019
Study completion31 Aug 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Stroke, AcuteStudies of the same condition, open and under way.
More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 494 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03411642
Sponsor's protocol ID: PV5225
Acronym: CONTEST
Status last verified: Nov 2022
First submitted: 19 Jan 2018
Last updated: 13 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 34496617

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Stroke, Acute trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Effectiveness Study of Transthoracic and Transesophageal Echocardiography in Stroke
ClinicalTrials.gov ID: NCT03411642
Acronym / sponsor ID: CONTEST / PV5225
Conditions: Stroke, Acute
Keywords: Stroke, echocardiography
Study type: Observational
Recruitment status: Completed
Enrolment: 494 participants (actual)
Lead sponsor: Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
Collaborators: Albertinen Krankenhaus, Regio Kliniken, Helios University Hospital Wuppertal, Kreiskliniken Reutlingen, Klinikum Karlsbad-Langensteinbach
Study start: 1 Jul 2017 (actual)
Primary completion: 30 Jun 2019 (actual)
Study completion: 31 Aug 2019 (actual)
First posted: 26 Jan 2018 (actual)
Results: Posted 13 Sep 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Cross-sectional

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with acute stroke in whom echocardiography is indicated will be studied by TTE and TEE.

Key inclusion criteria (3 listed)

acute ischemic stroke or transitory ischemic attack (TIA)
age ≥18 years
informed consent

Key exclusion criteria (1 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Number of Participants With Diagnostic Findings That Lead to a Change in Acute Treatment or Treatment for Secondary Prevention
Time frame: 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.

1 secondary outcome

Number of Patients With Change of Assessment of Stroke Etiology After TEE
Time frame: Inpatient treatment on a stroke unit usually <7 days

Results and safety

Results posted to the registry on 13 Sep 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients Included	494	454

Primary outcome: Number of Participants With Diagnostic Findings That Lead to a Change in Acute Treatment or Treatment for Secondary Prevention

Time frame: Inpatient treatment on a stroke unit usually <7 days. Count of participants. Unit: Participants

Measure	Patients Studied With Both TTE and TEE n = 454
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

1 secondary outcome is reported in the full results.

Adverse events

Time frame: In-patient treatment on a stroke unit usually <7 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients Receiving TTE	0 of 492 (0%)	0 of 492 (0%)	0 of 492
Patients Receiving TEE	0 of 454 (0%)	0 of 454 (0%)	0 of 454

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34496617Thomalla 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.

Related trials for Stroke, Acute

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Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Götz Thomalla, MD principal investigator

Universitätsklinikum Hamburg-Eppendorf

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke, Acute, run by Universitätsklinikum Hamburg-Eppendorf at 4 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Diagnostic Findings That Lead to a Change in Acute Treatment or Treatment for Secondary Prevention (time frame: Inpatient treatment on a stroke unit usually <7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03411642, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.