Acute Ischemic StrokeMissPerfeCTNCT04277728
Hypoperfusion-hypodensity Mismatch for the Identification of Patients With Stroke Within 4.5 Hours
An observational study of Acute Ischemic Stroke, run by University Hospital Muenster at 1 site in Germany.
Trial summary
Intravenous thrombolysis is recommended within 4.5 hours of stroke onset. The aim of the study is to evaluate whether a hypodensity on native CT within the virtually entire area of hypoperfusion on perfusion CT, i.e. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- hypoperfusion-hypodensity mismatch
- How many people
- 689 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2018to 31 Dec 2019
- 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 acute ischemic stroke and known time of symptom onset.
Who may be able to join
- acute ischemic stroke
- evidence of acute intracranial vessel occlusion (any supratentorial proximal or peripheral artery of the anterior cerebral artery, middle cerebral artery or posterior cerebral artery territory) by CT hyper dense thrombus and/or CTangiography vessel occlusion and/or by ischemic perfusion deficit
- evidence for acute ischemic perfusion deficit, i.e. acute symptoms attributable to ischemic CT perfusion lesion
- complete native CT and CTperfusion performed on admission
- sufficient CT and CTperfusion quality for judgement of acute ischemic hypodensity
- known time of symptom onset.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mismatch Between Hypoperfusion and Hypodensity on CT for the Identification of Patients With Stroke Onset Within 4.5 Hours
Intravenous thrombolysis is recommended within 4.5 hours of stroke onset. The aim of the study is to evaluate whether a hypodensity on native CT within the virtually entire area of hypoperfusion on perfusion CT, i.e. hypoperfusion-hypodensity mismatch, identifies patients within the time window of thrombolysis in a multicenter cohort. The investigators hypothesize hypoperfusion-hypodensity mismatch will identify patients ≤ 4,5 hours of symptom onset with >70% specificity and >85% positive predictive value.
- Conditions
- Acute Ischemic Stroke
- Being tested
- hypoperfusion-hypodensity mismatch
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypoperfusion-hypodensity mismatchDiagnostic test
hypoperfusion-hypodensity mismatch on computed tomography
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive predictive value of "hypoperfusion hypodensity mismatch" for the identification of patients ≤4.5 hours
Measured: on admission
Specificity of "hypoperfusion hypodensity mismatch" for the identification of patients ≤4.5 hours
Measured: on admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start1 Jan 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 689 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jens Minnerup, MD, Principal investigator, University Hospital Muenster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277728
- Sponsor's protocol ID
- 100001
- Acronym
- MissPerfeCT
- Status last verified
- Feb 2020
- First submitted
- 17 Feb 2020
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sporns PB, Kemmling A, Meyer L, Krogias C, Puetz V, Thierfelder KM, Duering M, Lukas C, Kaiser D, Langner S, Brehm A, Rotkopf LT, Kunz WG, Beuker C, Heindel W, Fiehler J, Schramm P, Wiendl H, Minnerup H, Psychogios MN, Minnerup J. Computed tomography hypoperfusion-hypodensity mismatch vs. automated perfusion mismatch to identify stroke patients eligible for thrombolysis. Front Neurol. 2023 Dec 29;14:1320620. doi: 10.3389/fneur.2023.1320620. eCollection 2023.
PubMed 38225983Sporns PB, Kemmling A, Minnerup H, Meyer L, Krogias C, Puetz V, Thierfelder K, Duering M, Kaiser D, Langner S, Massoth C, Brehm A, Rotkopf L, Kunz WG, Karch A, Fiehler J, Heindel W, Schramm P, Royl G, Wiendl H, Psychogios M, Minnerup J. CT Hypoperfusion-Hypodensity Mismatch to Identify Patients With Acute Ischemic Stroke Within 4.5 Hours of Symptom Onset. Neurology. 2021 Nov 23;97(21):e2088-e2095. doi: 10.1212/WNL.0000000000012891. Epub 2021 Oct 14.
PubMed 34649883
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mismatch Between Hypoperfusion and Hypodensity on CT for the Identification of Patients With Stroke Onset Within 4.5 Hours
- ClinicalTrials.gov ID
- NCT04277728
- Acronym / sponsor ID
- MissPerfeCT / 100001
- Conditions
- Acute Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 689 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 20 Feb 2020 (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.
Intravenous thrombolysis is recommended within 4.5 hours of stroke onset. The aim of the study is to evaluate whether a hypodensity on native CT within the virtually entire area of hypoperfusion on perfusion CT, i.e. hypoperfusion-hypodensity mismatch, identifies patients within the time window of thrombolysis in a multicenter cohort. The investigators hypothesize hypoperfusion-hypodensity mismatch will identify patients ≤ 4,5 hours of symptom onset with >70% specificity and >85% positive predictive value.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute ischemic stroke and known time of symptom onset.
Key inclusion criteria (6 listed)
- acute ischemic stroke
- evidence of acute intracranial vessel occlusion (any supratentorial proximal or peripheral artery of the anterior cerebral artery, middle cerebral artery or posterior cerebral artery territory) by CT hyper dense thrombus and/or CTangiography vessel occlusion and/or by ischemic perfusion deficit
- evidence for acute ischemic perfusion deficit, i.e. acute symptoms attributable to ischemic CT perfusion lesion
- complete native CT and CTperfusion performed on admission
- sufficient CT and CTperfusion quality for judgement of acute ischemic hypodensity
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| hypoperfusion-hypodensity mismatchhypoperfusion-hypodensity mismatch on computed tomography | Diagnostic test | – |
Primary outcome
Positive predictive value of "hypoperfusion hypodensity mismatch" for the identification of patients ≤4.5 hours
Time frame: on admission
Specificity of "hypoperfusion hypodensity mismatch" for the identification of patients ≤4.5 hours
Time frame: on admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Derived from this study: PubMed 38225983Sporns PB, Kemmling A, Meyer L, Krogias C, Puetz V, Thierfelder KM, Duering M, Lukas C, Kaiser D, Langner S, Brehm A, Rotkopf LT, Kunz WG, Beuker C, Heindel W, Fiehler J, Schramm P, Wiendl H, Minnerup H, Psychogios MN, Minnerup J. Computed tomography hypoperfusion-hypodensity mismatch vs. automated perfusion mismatch to identify stroke patients eligible for thrombolysis. Front Neurol. 2023 Dec 29;14:1320620. doi: 10.3389/fneur.2023.1320620. eCollection 2023.
- Derived from this study: PubMed 34649883Sporns PB, Kemmling A, Minnerup H, Meyer L, Krogias C, Puetz V, Thierfelder K, Duering M, Kaiser D, Langner S, Massoth C, Brehm A, Rotkopf L, Kunz WG, Karch A, Fiehler J, Heindel W, Schramm P, Royl G, Wiendl H, Psychogios M, Minnerup J. CT Hypoperfusion-Hypodensity Mismatch to Identify Patients With Acute Ischemic Stroke Within 4.5 Hours of Symptom Onset. Neurology. 2021 Nov 23;97(21):e2088-e2095. doi: 10.1212/WNL.0000000000012891. Epub 2021 Oct 14.
- Individual participant dataSharing planned: Undecided
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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.
Jens Minnerup, MD principal investigator
University Hospital Muenster
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 Acute Ischemic Stroke, run by University Hospital Muenster 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 6 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 20 Feb 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Positive predictive value of "hypoperfusion hypodensity mismatch" for the identification of patients ≤4.5 hours (time frame: on admission). The study lists 2 primary outcomes in all. 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 NCT04277728, which also lists 2 linked publications.
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 Feb 2020.