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

Stroke Clinical Trial

Official title:

Know Your Pulse Post Stroke - Peripheral Pulse Taking to Detect Paroxysmal Atrial Fibrillation After Ischemic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01858779
• Other study ID #: DE-ER-KYP
• Status: Completed
• Start date: May 2013
• Est. completion date: February 10, 2020

Study information

• Verified date: February 2020
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: February 10, 2020
• Est. primary completion date: February 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke

Intervention

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.

Locations

Country	Name	City	State
Germany	Universitätsklinikum Erlangen; Dept. of Neurology	Erlangen	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of newly detected cases of atrial fibrillation		6 months
Secondary	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	6 months
Secondary	Timepoint of detection of atrial fibrillation by MPP or holter ECG		6 months
Secondary	Modification of secondary preventive medication by detection of atrial fibrillation		6 months
Secondary	Recurrent stroke and mortality		6 months

External Links

•   Universitätsklinikum Erlangen; Dept. of Neurology