StrokeNCT01069276
Prehospital Transcranial Duplex in Patients With Acute Stroke
An observational study of Stroke, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
The aim of the study is to investigate patients with acute stroke prehospital with transcranial duplex ultrasound to detect an infarct of the middle cerebral artery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2008to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
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 clinical signs of acute stroke in the teritorial of the middle cerebral artery
Who may be able to join
- clinical signs of acute stroke
- possibility of TCD
Who cannot join
- acute interventions for vital signs required
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Medical Center of the Johannes Gutenberg-University Mainz
Mainz, 55131
About this study
The aim of the study is to investigate patients with acute stroke prehospital with transcranial duplex ultrasound to detect an infarct of the middle cerebral artery.
Read the detailed description
The investigation of the patients will be done by an anaesthesiologist who is part of the prehospital medical treatment in Germany. The main question is, wether a non neurologist can detect an infarction of the middle cerebral artery in a short time an lead the patient to the indicated clinic.
- Conditions
- Stroke
- Being tested
- No intervention in this study
- Keywords
- Stroke, prehospital ultrasound
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention in this studyOther
No intervention in this study
| Study group | Role | What they receive |
|---|---|---|
| Patients with clinical signs of stroke | Patients with clinical signs of stroke Receives: Other: No intervention in this study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prehospital detection of an infarction of the middle cerebral artery in patients with acute stroke
Measured: 5 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2010 (estimated)
- Study startSep 2008
- Primary completionNov 2012
- Study completionDec 2012
Why it stopped: Changes in preclinical treatment of stroke patients, no more emergency physician will met this patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Schramm, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01069276
- Sponsor's protocol ID
- 837.041.08
- Other IDs
- 6038
- Status last verified
- Jun 2020
- First submitted
- 16 Feb 2010
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehospital Transcranial Duplex in Patients With Acute Stroke
- ClinicalTrials.gov ID
- NCT01069276
- Acronym / sponsor ID
- 837.041.08
- Conditions
- Stroke
- Keywords
- Stroke, prehospital ultrasound
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Changes in preclinical treatment of stroke patients, no more emergency physician will met this patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 17 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to investigate patients with acute stroke prehospital with transcranial duplex ultrasound to detect an infarct of the middle cerebral artery.
Detailed description
The investigation of the patients will be done by an anaesthesiologist who is part of the prehospital medical treatment in Germany. The main question is, wether a non neurologist can detect an infarction of the middle cerebral artery in a short time an lead the patient to the indicated clinic.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with clinical signs of stroke | – | Other: No intervention in this studyPatients with clinical signs of stroke |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with clinical signs of acute stroke in the teritorial of the middle cerebral artery
Key inclusion criteria (2 listed)
- clinical signs of acute stroke
- possibility of TCD
Key exclusion criteria (1 listed)
- acute interventions for vital signs required
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention in this studyNo intervention in this study | Other | Patients with clinical signs of stroke |
Primary outcome
Prehospital detection of an infarction of the middle cerebral artery in patients with acute stroke
Time frame: 5 Minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Johannes Gutenberg University Mainz at 1 site 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 2 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: withdrawn, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Prehospital detection of an infarction of the middle cerebral artery in patients with acute stroke (time frame: 5 Minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2020.