Know Your Pulse Post Stroke-Measurement of Peripheral Pulse for Detection of Atrial Fibrillation After Ischemic Stroke
Know Your Pulse Post Stroke - Peripheral Pulse Taking to Detect Paroxysmal Atrial Fibrillation After Ischemic Stroke
1 other identifier
observational
300
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2013
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 13, 2013
CompletedFirst Posted
Study publicly available on registry
May 21, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 10, 2020
CompletedFebruary 12, 2020
February 1, 2020
6.8 years
May 13, 2013
February 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of newly detected cases of atrial fibrillation
6 months
Secondary Outcomes (4)
Comparison of detection rates by MPP and by serial holter ECG (3 months, 6 months)
6 months
Timepoint of detection of atrial fibrillation by MPP or holter ECG
6 months
Modification of secondary preventive medication by detection of atrial fibrillation
6 months
Recurrent stroke and mortality
6 months
Study Arms (1)
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.
Interventions
All patients will be introduced and trained for the measurement of peripheral pulse. Patients will keep a pulse-diary tro detect atrial fibrillation.
All petients will receive regular 72h Holter ECG at 3 and 6 months after inclusion in the study.
Eligibility Criteria
Patients with acute ischemic stroke without the history of atrial fibrillation
You may qualify if:
- 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
You may not qualify if:
- Previously documented episode of atrial fibrillation or flutter
- Patient and/or relatives are unable to reliably perform pulse self measurement
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universitätsklinikum Erlangen; Dept. of Neurology
Erlangen, Bavaria, 91054, Germany
Related Publications (1)
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.
PMID: 25804569DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin Köhrmann, MD
Universitätsklinikum Erlangen
- PRINCIPAL INVESTIGATOR
Bernd Kallmünzer, MD
Universitätsklinikum Erlangen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
May 13, 2013
First Posted
May 21, 2013
Study Start
May 1, 2013
Primary Completion
February 10, 2020
Study Completion
February 10, 2020
Last Updated
February 12, 2020
Record last verified: 2020-02