Acute Ischemic StrokeACUTENCT06176872
Cardiac CT Angiography in Patients With Acute Ischemic Stroke
An observational study of Acute Ischemic Stroke and Coronary Artery Disease, run by Universitätsklinikum Hamburg-Eppendorf.
Trial summary
Mortality rates after acute ischemic stroke remain high despite continuously improving treatment. In this context, it is important to note that a relevant portion of acute ischemic stroke patients die from adverse cardiovascular events, such as myocardial infarction, rather than from complications associated with the… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Acute Ischemic Stroke, Coronary Artery Disease
- What is being tested?
- Cardiac Computed Tomography Angiography
- How many people
- 165 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 40 years or above, presenting at the Emergency Department of the University Medical Center Hamburg-Eppendorf (primary care clinic) with a suspected AIS.
Who may be able to join
- Patients aged 40 years or above, presenting at the Emergency Department of the University Medical Center Hamburg-Eppendorf with a suspected acute ischemic stroke and a relevant neurological deficit (NIHSS score > 4).
Who cannot join
- A causal differential diagnosis for the acute stroke syndrome with absent intracranial vessel occlusion.
- No correlation for the patients' symptoms in the cranial CTA (no vessel obstruction).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessment of Cardiac CT Angiography in Patients Undergoing Thrombectomy for Ischemic Stroke
Mortality rates after acute ischemic stroke remain high despite continuously improving treatment. In this context, it is important to note that a relevant portion of acute ischemic stroke patients die from adverse cardiovascular events, such as myocardial infarction, rather than from complications associated with the stroke itself. A possible reason might be that this patient group often suffers from at least moderate asymptomatic coronary artery disease. This study seeks to integrate cardiac computed tomography angiography into the standard-of-care diagnostic protocol of acute ischemic stroke. The aim of this prospective mono-centric trial is to enable accurate diagnosis of therapy-relevant coronary artery disease, other concomitant cardiac findings and cardiac causes of acute ischemic stroke, without delaying stroke therapy. In the long-run, the goal is to investigate whether cardiac computed tomography angiography and the resulting therapeutic measures (interventions or medications added) can improve functional outcome and rate of adverse cardiac complications in patients with acute ischemic stroke compared to a retrospective matched-cohort of patients without cardiac CT imaging.
- Conditions
- Acute Ischemic Stroke, Coronary Artery Disease
- Being tested
- Cardiac Computed Tomography Angiography
- Keywords
- Computed Tomography Angiography
- Medical subject headings
- Ischemic Stroke, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Computed Tomography AngiographyDiagnostic test
Non-invasive imaging of the heart, the greater vessels and the coronary arteries using computed tomography.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Computed Tomography Angiography | Patients with acute ischemic stroke who receive cardiac computed tomography angiography as part of the routine diagnostic work-up of acute ischemic stroke. Receives: Diagnostic Test: Cardiac Computed Tomography Angiography | |
| Retrospective matched cohort | A retrospective matched cohort of patients with acute ischemic stroke who did not receive cardiac computed tomography angiography. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of therapy-relevant CAD and concomitant cardiac findings resulting in new therapeutic measurements.
Number of (newly) prescribed medications (e.g., anticoagulants), cardiac diagnostics/interventions/planned interventions, clinical status (NIHSS, mRs).
Measured: 1 day at hospital discharge
Secondary outcomes (1)
The rate of adverse cardiovascular events (MACE).
rate of major adverse cardiovascular events (MACE).
Measured: 90 and 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start1 Jan 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies 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
- Prospective
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- Siemens Healthcare Diagnostics Inc
- Responsible party
- Principal investigator, Gabriel Broocks, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Gabriel Broocks, MD, Principal investigator, Universitätsklinikum Hamburg-EppendorfMathias Meyer, MD, Principal investigator, Universitätsklinikum Hamburg-EppendorfJennifer Erley, MD, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06176872
- Sponsor's protocol ID
- 2022-100951-BO-ff
- Acronym
- ACUTE
- Status last verified
- Dec 2023
- First submitted
- 23 Nov 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to data protection agreements, it is not possible to share the IPD. Nevertheless,parts of the datasets can be made available from the PIs upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cardiac CT Angiography in Patients Undergoing Thrombectomy for Ischemic Stroke
- ClinicalTrials.gov ID
- NCT06176872
- Acronym / sponsor ID
- ACUTE / 2022-100951-BO-ff
- Conditions
- Acute Ischemic Stroke, Coronary Artery Disease
- Keywords
- Computed Tomography Angiography
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- Siemens Healthcare Diagnostics Inc
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 20 Dec 2023 (actual)
- 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.
Mortality rates after acute ischemic stroke remain high despite continuously improving treatment. In this context, it is important to note that a relevant portion of acute ischemic stroke patients die from adverse cardiovascular events, such as myocardial infarction, rather than from complications associated with the stroke itself. A possible reason might be that this patient group often suffers from at least moderate asymptomatic coronary artery disease. This study seeks to integrate cardiac computed tomography angiography into the standard-of-care diagnostic protocol of acute ischemic stroke. The aim of this prospective mono-centric trial is to enable accurate diagnosis of therapy-relevant coronary artery disease, other concomitant cardiac findings and cardiac causes of acute ischemic stroke, without delaying stroke therapy. In the long-run, the goal is to investigate whether cardiac computed tomography angiography and the resulting therapeutic measures (interventions or medications added) can improve functional outcome and rate of adverse cardiac complications in patients with acute ischemic stroke compared to a retrospective matched-cohort of patients without cardiac CT imaging.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiac Computed Tomography Angiography | – | Diagnostic Test: Cardiac Computed Tomography AngiographyPatients with acute ischemic stroke who receive cardiac computed tomography angiography as part of the routine diagnostic work-up of acute ischemic stroke. |
| Retrospective matched cohort | – | –A retrospective matched cohort of patients with acute ischemic stroke who did not receive cardiac computed tomography angiography. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 40 years or above, presenting at the Emergency Department of the University Medical Center Hamburg-Eppendorf (primary care clinic) with a suspected AIS.
Key inclusion criteria (1 listed)
- Patients aged 40 years or above, presenting at the Emergency Department of the University Medical Center Hamburg-Eppendorf with a suspected acute ischemic stroke and a relevant neurological deficit (NIHSS score > 4).
Key exclusion criteria (2 listed)
- A causal differential diagnosis for the acute stroke syndrome with absent intracranial vessel occlusion.
- No correlation for the patients' symptoms in the cranial CTA (no vessel obstruction).
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 |
|---|---|---|
| Cardiac Computed Tomography AngiographyNon-invasive imaging of the heart, the greater vessels and the coronary arteries using computed tomography. | Diagnostic test | Cardiac Computed Tomography Angiography |
Primary outcome
Diagnosis of therapy-relevant CAD and concomitant cardiac findings resulting in new therapeutic measurements.
Time frame: 1 day at hospital discharge
Number of (newly) prescribed medications (e.g., anticoagulants), cardiac diagnostics/interventions/planned interventions, clinical status (NIHSS, mRs).
1 secondary outcome
The rate of adverse cardiovascular events (MACE).
Time frame: 90 and 365 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Individual participant dataSharing planned: No. Due to data protection agreements, it is not possible to share the IPD. Nevertheless,parts of the datasets can be made available from the PIs upon reasonable request.
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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.
Gabriel Broocks, MD principal investigator
Universitätsklinikum Hamburg-Eppendorf
Mathias Meyer, MD principal investigator
Universitätsklinikum Hamburg-Eppendorf
Jennifer Erley, MD principal investigator
Universitätsklinikum Hamburg-Eppendorf
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke and Coronary Artery Disease, run by Universitätsklinikum Hamburg-Eppendorf.
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 1 inclusion and 2 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: opening soon, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Erley, MD (+4915157487213, j.erley@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of therapy-relevant CAD and concomitant cardiac findings resulting in new therapeutic measurements. (time frame: 1 day at hospital discharge). 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 20 Dec 2023.