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Know Your Pulse Post Stroke-Measurement of Peripheral Pulse for Detection of Atrial Fibrillation After Ischemic Stroke

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ClinicalTrials.gov Identifier: NCT01858779
Recruitment Status : Unknown
Verified May 2013 by Martin Köhrmann, University of Erlangen-Nürnberg Medical School.
Recruitment status was:  Recruiting
First Posted : May 21, 2013
Last Update Posted : June 3, 2013
Sponsor:
Information provided by (Responsible Party):
Martin Köhrmann, University of Erlangen-Nürnberg Medical School

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.


Condition or disease Intervention/treatment
Stroke Atrial Fibrillation Behavioral: Measurement of peripheral pulse Device: 72h holter ECG

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 Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Know Your Pulse Post Stroke - Peripheral Pulse Taking to Detect Paroxysmal Atrial Fibrillation After Ischemic Stroke
Study Start Date : May 2013
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.

Behavioral: Measurement of peripheral pulse
All patients will be introduced and trained for the measurement of peripheral pulse. Patients will keep a pulse-diary tro detect atrial fibrillation.

Device: 72h holter ECG
All petients will receive regular 72h Holter ECG at 3 and 6 months after inclusion in the study.
Other Name: Regular 72h Holter ECGs are used




Primary Outcome Measures :
  1. Number of newly detected cases of atrial fibrillation [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Comparison of detection rates by MPP and by serial holter ECG (3 months, 6 months) [ Time Frame: 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

  2. Timepoint of detection of atrial fibrillation by MPP or holter ECG [ Time Frame: 6 months ]
  3. Modification of secondary preventive medication by detection of atrial fibrillation [ Time Frame: 6 months ]
  4. Recurrent stroke and mortality [ Time Frame: 6 months ]


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with acute ischemic stroke without the history of atrial fibrillation
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Previously documented episode of atrial fibrillation or flutter
  • Patient and/or relatives are unable to reliably perform pulse self measurement

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01858779


Contacts
Contact: Martin Köhrmann, MD +49 9131 85 ext 39190 martin.koehrmann@uk-erlangen.de
Contact: Bernd Kallmünzer, MD +49 9131 85 ext 39190 bernd.kallmuenzer@uk-erlangen.de

Locations
Germany
Universitätsklinikum Erlangen; Dept. of Neurology Recruiting
Erlangen, Bavaria, Germany, 91054
Contact: Martin Köhrmann, MD    +49 9131 85 ext 39190    martin.koehrmann@uk-erlangen.de   
Contact: Bernd Kallmünzer, MD    +49 9131 85 ext 39190    bernd.kallmuenzer@uk-erlangen.de   
Principal Investigator: Martin Köhrmann, MD         
Principal Investigator: Bernd Kallmünzer, MD         
Sub-Investigator: Natalia Kurka, MD         
Principal Investigator: Lars Marquardt, MD PHD         
Sub-Investigator: Kosmas Macha, MD         
Sub-Investigator: David Stark, MD         
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
Study Chair: Martin Köhrmann, MD Universitätsklinikum Erlangen
Principal Investigator: Bernd Kallmünzer, MD Universitätsklinikum Erlangen
Principal Investigator: Lars Marquardt, MD PHD Universitätsklinikum Erlangen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Martin Köhrmann, MD, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT01858779     History of Changes
Other Study ID Numbers: DE-ER-KYP
First Posted: May 21, 2013    Key Record Dates
Last Update Posted: June 3, 2013
Last Verified: May 2013

Keywords provided by Martin Köhrmann, University of Erlangen-Nürnberg Medical School:
stroke
atrial fibrillation
secondary prevention of stroke
peripheral pulse measurement

Additional relevant MeSH terms:
Stroke
Atrial Fibrillation
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes