StrokeNCT01858779
Know Your Pulse Post Stroke-Measurement of Peripheral Pulse for Detection of Atrial Fibrillation After Ischemic Stroke
An observational study of Stroke and Atrial Fibrillation, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
Atrial fibrillation (AF) is the most common cause of cardioembolism and a leading cause of ischemic stroke. The diagnosis of AF after cerebral ischemia is difficult to establish even during the treatment at specialised stroke units, as paroxysmal episodes may terminate spontaneously before arrival at the hospital and… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Stroke, Atrial Fibrillation
- What is being tested?
- Measurement of peripheral pulse and 72h holter ECG
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- May 2013to 10 Feb 2020
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute ischemic stroke without the history of atrial fibrillation
Who may be able to join
- Acute cerebral ischemia and treatment on our stroke unit
- No previous history of AF and no evidence of AF during complete diagnostic work up (including at least ECG, telemetric monitoring, transthoracic echocardiography, extracranial und transcranial dopplersonography, routine laboratory)
- Patient and/ relatives understand study procedures and is willing and able to learn the method of pulse measurements
- Min. CHADS2-Score of 1 (prior to present stroke)
- Age 50 and above
Who cannot join
- Previously documented episode of atrial fibrillation or flutter
- Patient and/or relatives are unable to reliably perform pulse self measurement
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsklinikum Erlangen; Dept. of Neurology
Erlangen, Bavaria, 91054
About this study
Official title: Know Your Pulse Post Stroke - Peripheral Pulse Taking to Detect Paroxysmal Atrial Fibrillation After Ischemic Stroke
Atrial fibrillation (AF) is the most common cause of cardioembolism and a leading cause of ischemic stroke. The diagnosis of AF after cerebral ischemia is difficult to establish even during the treatment at specialised stroke units, as paroxysmal episodes may terminate spontaneously before arrival at the hospital and do not always show early recurrence. However, the diagnosis of AF is of particular clinical relevance since adaequate anticoagulation is one of the most effective secondary preventive treatments in stroke. The detection rate of AF after stroke increases progressively by extending the duration and intensity of cardiac monitoring. For this purpose innovative medical devices and implantable event recorders have been suggested. However, high socioeconomic expenses, malcompliance and the invasiveness of some of these approaches currently limit their use to a minority of affected patients, while the growing number of stroke survivors is lacking access to free and simple screening tools.
For primary prevention, the measurement of the peripheral pulse (MPP) is currently the only guideline-recommended screening method among individuals aged 65 years or older. In contrast, MPP has never been applied in the setting of secondary stroke prevention, probably because several factors were expected to interfere with this simple technique, including sensomotor and neuropsychiologic handicaps of stroke patients 18. This study investigates feasibility and validity of MPP in this cohort (pilot phase) and compares daily MPP for 6 months with repeated holter-ECG in patients after ischemic stroke.
Read the detailed description
This prospective, single-center, observational trial will enroll n=300 patients with acute cerebral ischemia without detection of AF after standard stroke unit diagnostic procedures. During the acute in-hospital phase at the stroke unit, patients and, if available, relatives are introduced to and trained for peripheral pulse self measurements. Experiences on this educational process, including feasibility and diagnostic accuracy have already been gained during a pilot phase of the study (n=256 patients). Pulse rate and subjective perception of absolute pulse arrhythmia are assessed by the patient and/or relatives at least three times daily or during palpitations, with results being documented in a patient diary. After hospital discharge, the patient continues with daily measurements (min. 3 times per day) for 6 months. In parallel the patient will transmit ECGs using a handheld mobile ECG-device as a control to the study center. This ECG will be reviewed for episodes of atrial fibrillation. If the patient recognizes new pulse arrhythmias or an excess of pulse rate beyond an upper or lower limit of >120/min or <45/min, resp., the patient is requested to transmit an additional ECG to the study center. In this case, a 12-lead ECG and further diagnostic tests (e.g. cardiac marker or echocardiography) is initiated. As an internal control group the same patients will receive standard 72h holter ECG at 3 and 6 months which will be evaluated for episodes of atrial fibrillation by an investigator blinded for clinical data as well as results from the pulse measurements. Detection rates (pulse measurements, holter ECGs) as well as time of first diagnosis of atrial fibrillation using the different diagnostic approaches will be important endpoints of the study.
- Conditions
- Stroke, Atrial Fibrillation
- Being tested
- Measurement of peripheral pulse, 72h holter ECG
- Keywords
- stroke, atrial fibrillation, secondary prevention of stroke, peripheral pulse measurement
- Medical subject headings
- Stroke, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of peripheral pulseBehavioural
All patients will be introduced and trained for the measurement of peripheral pulse. Patients will keep a pulse-diary tro detect atrial fibrillation.
72h holter ECGDevice
Also called Regular 72h Holter ECGs are used
All petients will receive regular 72h Holter ECG at 3 and 6 months after inclusion in the study.
| Study group | Role | What they receive |
|---|---|---|
| Study-cohort | Patients after ischemic stroke without a history of atrial fibrillation will perform measurements of peripheral pulse three times daily and in case of symptomatic arrhythmic episodes. Results will be entered into a diary which will be send to the center every month. In parallel to the measurements, patients will transmit ECGs via a mobile ECG recorder to the study center.
At 3 and 6 months after inclusion patients will be evaluated using 72h holter ECG. During the whole study period AEs as well as SAEs and changes in medications are recorded. Receives: Behavioral: Measurement of peripheral pulse; Device: 72h holter ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of newly detected cases of atrial fibrillation
Measured: 6 months
Secondary outcomes (4)
Comparison of detection rates by MPP and by serial holter ECG (3 months, 6 months)
Rates of newly detected cases of atrial fibrillation using MPP are compared to the detection rate using holter ECG at 3 months and 6 months post inclusion
Measured: 6 months
Timepoint of detection of atrial fibrillation by MPP or holter ECG
Measured: 6 months
Modification of secondary preventive medication by detection of atrial fibrillation
Measured: 6 months
Recurrent stroke and mortality
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startMay 2013
- Primary completion10 Feb 2020
- Study completion10 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 of Erlangen-Nürnberg Medical SchoolThe 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bernd Kallmünzer, University of Erlangen-Nürnberg Medical School
- Investigators
- Martin Köhrmann, MD, Principal investigator, University of Erlangen-NürnbergBernd Kallmünzer, MD, Principal investigator, University of Erlangen-Nürnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01858779
- Sponsor's protocol ID
- DE-ER-KYP
- Status last verified
- Feb 2020
- First submitted
- 13 May 2013
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Kallmunzer B, Bobinger T, Kopp M, Kurka N, Arnold M, Hilz MJ, Schwab S, Kohrmann M. Impact of heart rate dynamics on mortality in the early phase after ischemic stroke: a prospective observational trial. J Stroke Cerebrovasc Dis. 2015 May;24(5):946-51. doi: 10.1016/j.jstrokecerebrovasdis.2014.12.009. Epub 2015 Mar 21.
PubMed 25804569
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Know Your Pulse Post Stroke - Peripheral Pulse Taking to Detect Paroxysmal Atrial Fibrillation After Ischemic Stroke
- ClinicalTrials.gov ID
- NCT01858779
- Acronym / sponsor ID
- DE-ER-KYP
- Conditions
- Stroke, Atrial Fibrillation
- Keywords
- stroke, atrial fibrillation, secondary prevention of stroke, peripheral pulse measurement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 21 May 2013 (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.
Atrial fibrillation (AF) is the most common cause of cardioembolism and a leading cause of ischemic stroke. The diagnosis of AF after cerebral ischemia is difficult to establish even during the treatment at specialised stroke units, as paroxysmal episodes may terminate spontaneously before arrival at the hospital and do not always show early recurrence. However, the diagnosis of AF is of particular clinical relevance since adaequate anticoagulation is one of the most effective secondary preventive treatments in stroke. The detection rate of AF after stroke increases progressively by extending the duration and intensity of cardiac monitoring. For this purpose innovative medical devices and implantable event recorders have been suggested. However, high socioeconomic expenses, malcompliance and the invasiveness of some of these approaches currently limit their use to a minority of affected patients, while the growing number of stroke survivors is lacking access to free and simple screening tools.
For primary prevention, the measurement of the peripheral pulse (MPP) is currently the only guideline-recommended screening method among individuals aged 65 years or older. In contrast, MPP has never been applied in the setting of secondary stroke prevention, probably because several factors were expected to interfere with this simple technique, including sensomotor and neuropsychiologic handicaps of stroke patients 18. This study investigates feasibility and validity of MPP in this cohort (pilot phase) and compares daily MPP for 6 months with repeated holter-ECG in patients after ischemic stroke.
Detailed description
This prospective, single-center, observational trial will enroll n=300 patients with acute cerebral ischemia without detection of AF after standard stroke unit diagnostic procedures. During the acute in-hospital phase at the stroke unit, patients and, if available, relatives are introduced to and trained for peripheral pulse self measurements. Experiences on this educational process, including feasibility and diagnostic accuracy have already been gained during a pilot phase of the study (n=256 patients). Pulse rate and subjective perception of absolute pulse arrhythmia are assessed by the patient and/or relatives at least three times daily or during palpitations, with results being documented in a patient diary. After hospital discharge, the patient continues with daily measurements (min. 3 times per day) for 6 months. In parallel the patient will transmit ECGs using a handheld mobile ECG-device as a control to the study center. This ECG will be reviewed for episodes of atrial fibrillation. If the patient recognizes new pulse arrhythmias or an excess of pulse rate beyond an upper or lower limit of >120/min or <45/min, resp., the patient is requested to transmit an additional ECG to the study center. In this case, a 12-lead ECG and further diagnostic tests (e.g. cardiac marker or echocardiography) is initiated. As an internal control group the same patients will receive standard 72h holter ECG at 3 and 6 months which will be evaluated for episodes of atrial fibrillation by an investigator blinded for clinical data as well as results from the pulse measurements. Detection rates (pulse measurements, holter ECGs) as well as time of first diagnosis of atrial fibrillation using the different diagnostic approaches will be important endpoints of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study-cohort | – | Behavioral: Measurement of peripheral pulse, Device: 72h holter ECGPatients after ischemic stroke without a history of atrial fibrillation will perform measurements of peripheral pulse three times daily and in case of symptomatic arrhythmic episodes. Results will be entered into a diary which will be send to the center every month. In parallel to the measurements, patients will transmit ECGs via a mobile ECG recorder to the study center. At 3 and 6 months after inclusion patients will be evaluated using 72h holter ECG. During the whole study period AEs as well as SAEs and changes in medications are recorded. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute ischemic stroke without the history of atrial fibrillation
Key inclusion criteria (5 listed)
- Acute cerebral ischemia and treatment on our stroke unit
- No previous history of AF and no evidence of AF during complete diagnostic work up (including at least ECG, telemetric monitoring, transthoracic echocardiography, extracranial und transcranial dopplersonography, routine laboratory)
- Patient and/ relatives understand study procedures and is willing and able to learn the method of pulse measurements
- Min. CHADS2-Score of 1 (prior to present stroke)
- Age 50 and above
Key exclusion criteria (2 listed)
- Previously documented episode of atrial fibrillation or flutter
- Patient and/or relatives are unable to reliably perform pulse self measurement
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 |
|---|---|---|
| Measurement of peripheral pulseAll patients will be introduced and trained for the measurement of peripheral pulse. Patients will keep a pulse-diary tro detect atrial fibrillation. | Behavioural | Study-cohort |
| 72h holter ECGAlso: Regular 72h Holter ECGs are usedAll petients will receive regular 72h Holter ECG at 3 and 6 months after inclusion in the study. | Device | Study-cohort |
Primary outcome
Number of newly detected cases of atrial fibrillation
Time frame: 6 months
4 secondary outcomes
Comparison of detection rates by MPP and by serial holter ECG (3 months, 6 months)
Time frame: 6 months
Timepoint of detection of atrial fibrillation by MPP or holter ECG
Time frame: 6 months
Modification of secondary preventive medication by detection of atrial fibrillation
Time frame: 6 months
Recurrent stroke and mortality
Time frame: 6 months
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 12 Feb 2020.
- Derived from this study: PubMed 25804569Kallmunzer B, Bobinger T, Kopp M, Kurka N, Arnold M, Hilz MJ, Schwab S, Kohrmann M. Impact of heart rate dynamics on mortality in the early phase after ischemic stroke: a prospective observational trial. J Stroke Cerebrovasc Dis. 2015 May;24(5):946-51. doi: 10.1016/j.jstrokecerebrovasdis.2014.12.009. Epub 2015 Mar 21.
- Universitätsklinikum Erlangen; Dept. of NeurologyLink provided by the sponsor.
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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.
Martin Köhrmann, MD principal investigator
University of Erlangen-Nürnberg
Bernd Kallmünzer, MD principal investigator
University of Erlangen-Nürnberg
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 and Atrial Fibrillation, run by University of Erlangen-Nürnberg Medical School 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 5 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: finished, as of the sponsor's last update on 12 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?
Number of newly detected cases of atrial fibrillation (time frame: 6 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 NCT01858779, 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 12 Feb 2020.