StrokeNCT04352790
Multifactorial Risk Stratification in Stroke Patients With Cardiac Disease
An observational study of Stroke and Cardiac Disease, run by University Hospital Tuebingen.
Trial summary
Prospective registry for multifactorial risk factor assessment, enrolling consecutive ischemic stroke/transient ischemic attack patients with structural, inflammatory, or arrhythmogenic cardiac disease, who are admitted to our University Hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Cardiac Disease
- How many people
- 878 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2012to 31 Dec 2020
- How long will I take part?
- 12 Months
- 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: Consecutive ischemic stroke/transient ischemic attack patients (brain, spinal crd, or retinal) with structural, inflammatory, or arrhythmogenic cardiac disease, who are admitted to our University Hospital.
Who may be able to join
- Ischemic stroke or transient ischemic attack (brain, spinal cord, or retinal)
Who cannot join
- Acute intracranial hemorrhage
About this study
Official title: Multifactorial Risk Stratification in Patients With Ischemic Stroke or Transient Ischemic Attack and Structural, Inflammatory, or Arrhythmogenic Cardiac Disease
Prospective registry for multifactorial risk factor assessment, enrolling consecutive ischemic stroke/transient ischemic attack patients with structural, inflammatory, or arrhythmogenic cardiac disease, who are admitted to our University Hospital.
Read the detailed description
The prospective registry shall provide new insights into the multiple associations, and respective therapeutic implications of cardio-vascular risk factors and stroke. For that reason consecutive patients with ischemic stroke/transient ischemic attack (brain, spinal cord, or retinal) and structural (e.g. patent foramen ovale), septic or aseptic endocarditis or myocarditis, or supra-ventricular or ventricular arrhythmia, who are admitted to our University Hospital, are enrolled. Multifactorial assessment of risk factors is based on medical history, laboratory biomarkers, electrocardiogram incl. cardiac autonomic function analysis, and (long-term) cardiac rhythm monitoring, as well as transthoracic and transesophageal echocardiography. Inclusion of follow-up visits permit longitudinal and prognostic evaluation of routine diagnostic and therapeutic interventions for secondary stroke prevention (e.g. implantable loop recorders or interventional closure of patent foramen ovale).
- Conditions
- Stroke, Cardiac Disease
- Keywords
- patent foramen ovale, loop recorder, atrial fibrillation, heart rhythm monitoring, autonomic dysfunction, cryptogenic stroke, embolic stroke of undetermined source, ESUS, transient ischemic attack, retinal ischemia
- Medical subject headings
- Stroke, Heart Diseases, Foramen Ovale, Patent, Atrial Fibrillation, Primary Dysautonomias, Ischemic Stroke, Ischemic Attack, Transient
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of any stroke
Recurrent ischemic stroke or intracranial hemorrhage during follow-up
Measured: ≥ 12 months
Secondary outcomes (11)
Rate of mortality
Death from any cause during follow-up
Measured: ≥ 12 months
Rate of ischemic stroke
Ischemic stroke recurrence during follow-up
Measured: ≥ 12 months
Rate of transient ischemic attack
Transient ischemic attack recurrence during follow-up
Measured: ≥ 12 months
Rate of systemic embolism
Systemic embolism during follow-up
Measured: ≥ 12 months
Rate of myocardial infarction
Myocardial infarction during follow-up
Measured: ≥ 12 months
Rate of intracranial hemorrhage
Intracranial hemorrhage during follow-up
Measured: ≥ 12 months
Rate of major Bleedings
Major Bleedings during follow-up
Measured: ≥ 12 months
Rate of major or clinically relevant non-major bleedings
Major or clinically relevant non-major bleedings during follow-up
Measured: ≥ 12 months
Rate of serious adverse events
Serious adverse events during follow-up
Measured: ≥ 12 months
Rate of new-onset atrial fibrillation
Detection of atrial fibrillation during follow-up
Measured: ≥ 12 months
modified Rankin Score; range from 0 to 6, with '0' indicating the best outcome (i.e. no deficit), and '6' the worst outcome (i.e. death)
modified Rankin Scale score at follow-up
Measured: ≥ 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start1 Mar 2012
- Primary completion30 Nov 2019
- Study completion31 Dec 2020 (estimated)
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 StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- 878 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04352790
- Sponsor's protocol ID
- 402/2009BO2, 522/2012BO2
- Status last verified
- Apr 2020
- First submitted
- 15 Apr 2020
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Poli S, Diedler J, Hartig F, Gotz N, Bauer A, Sachse T, Muller K, Muller I, Stimpfle F, Duckheim M, Steeg M, Eick C, Schreieck J, Gawaz M, Ziemann U, Zuern CS. Insertable cardiac monitors after cryptogenic stroke--a risk factor based approach to enhance the detection rate for paroxysmal atrial fibrillation. Eur J Neurol. 2016 Feb;23(2):375-81. doi: 10.1111/ene.12843. Epub 2015 Oct 16.
PubMed 26470854Poli S, Siebert E, Mbroh J, Poli K, Krumbholz M, Mengel A, Greulich S, Hartig F, Muller KAL, Bocksch W, Gawaz M, Ziemann U, Zuern CS. Closure or medical therapy of patent foramen ovale in cryptogenic stroke: prospective case series. Neurol Res Pract. 2021 Apr 1;3(1):16. doi: 10.1186/s42466-021-00114-3.
PubMed 33789756
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multifactorial Risk Stratification in Patients With Ischemic Stroke or Transient Ischemic Attack and Structural, Inflammatory, or Arrhythmogenic Cardiac Disease
- ClinicalTrials.gov ID
- NCT04352790
- Acronym / sponsor ID
- 402/2009BO2, 522/2012BO2
- Conditions
- Stroke, Cardiac Disease
- Keywords
- patent foramen ovale, loop recorder, atrial fibrillation, heart rhythm monitoring, autonomic dysfunction, cryptogenic stroke, embolic stroke of undetermined source, ESUS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 878 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 1 Mar 2012 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 20 Apr 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.
Prospective registry for multifactorial risk factor assessment, enrolling consecutive ischemic stroke/transient ischemic attack patients with structural, inflammatory, or arrhythmogenic cardiac disease, who are admitted to our University Hospital.
Detailed description
The prospective registry shall provide new insights into the multiple associations, and respective therapeutic implications of cardio-vascular risk factors and stroke. For that reason consecutive patients with ischemic stroke/transient ischemic attack (brain, spinal cord, or retinal) and structural (e.g. patent foramen ovale), septic or aseptic endocarditis or myocarditis, or supra-ventricular or ventricular arrhythmia, who are admitted to our University Hospital, are enrolled. Multifactorial assessment of risk factors is based on medical history, laboratory biomarkers, electrocardiogram incl. cardiac autonomic function analysis, and (long-term) cardiac rhythm monitoring, as well as transthoracic and transesophageal echocardiography. Inclusion of follow-up visits permit longitudinal and prognostic evaluation of routine diagnostic and therapeutic interventions for secondary stroke prevention (e.g. implantable loop recorders or interventional closure of patent foramen ovale).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive ischemic stroke/transient ischemic attack patients (brain, spinal crd, or retinal) with structural, inflammatory, or arrhythmogenic cardiac disease, who are admitted to our University Hospital.
Key inclusion criteria (1 listed)
- Ischemic stroke or transient ischemic attack (brain, spinal cord, or retinal)
Key exclusion criteria (1 listed)
- Acute intracranial hemorrhage
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
Rate of any stroke
Time frame: ≥ 12 months
Recurrent ischemic stroke or intracranial hemorrhage during follow-up
11 secondary outcomes
Rate of mortality
Time frame: ≥ 12 months
Rate of ischemic stroke
Time frame: ≥ 12 months
Rate of transient ischemic attack
Time frame: ≥ 12 months
Rate of systemic embolism
Time frame: ≥ 12 months
Rate of myocardial infarction
Time frame: ≥ 12 months
Rate of intracranial hemorrhage
Time frame: ≥ 12 months
Rate of major Bleedings
Time frame: ≥ 12 months
Rate of major or clinically relevant non-major bleedings
Time frame: ≥ 12 months
Rate of serious adverse events
Time frame: ≥ 12 months
Rate of new-onset atrial fibrillation
Time frame: ≥ 12 months
modified Rankin Score; range from 0 to 6, with '0' indicating the best outcome (i.e. no deficit), and '6' the worst outcome (i.e. death)
Time frame: ≥ 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
- Results publication: PubMed 26470854Poli S, Diedler J, Hartig F, Gotz N, Bauer A, Sachse T, Muller K, Muller I, Stimpfle F, Duckheim M, Steeg M, Eick C, Schreieck J, Gawaz M, Ziemann U, Zuern CS. Insertable cardiac monitors after cryptogenic stroke--a risk factor based approach to enhance the detection rate for paroxysmal atrial fibrillation. Eur J Neurol. 2016 Feb;23(2):375-81. doi: 10.1111/ene.12843. Epub 2015 Oct 16.
- Derived from this study: PubMed 33789756Poli S, Siebert E, Mbroh J, Poli K, Krumbholz M, Mengel A, Greulich S, Hartig F, Muller KAL, Bocksch W, Gawaz M, Ziemann U, Zuern CS. Closure or medical therapy of patent foramen ovale in cryptogenic stroke: prospective case series. Neurol Res Pract. 2021 Apr 1;3(1):16. doi: 10.1186/s42466-021-00114-3.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Cardiac Disease, run by University Hospital Tuebingen.
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 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: status not confirmed, as of the sponsor's last update on 22 Apr 2020. 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?
Results are not available in the source record.
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?
Rate of any stroke (time frame: ≥ 12 months). 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 NCT04352790, 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 22 Apr 2020.