Early prolonged ambulatory heart monitoring in patients with stroke

• Register: ISRCTN
• Last refreshed on: 26 August 2019
• Main ID: ISRCTN50253271
• Date of registration: 28/01/2016
• Prospective Registration: Yes
• Primary sponsor: Kings College Hospital NHS Foundation Trust
• Public title: Early prolonged ambulatory heart monitoring in patients with stroke
• Scientific title: Early Prolonged Ambulatory Cardiac monitoring in Stroke: A prospective randomised open blinded endpoint study
• Date of first enrolment: 03/02/2016
• Target sample size: 120
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN50253271
• Study type: Interventional
• Study design: Prospective randomised open blinded endpoint study (Diagnostic)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: James Teo

Key inclusion & exclusion criteria

Inclusion criteria:
1. Aged 18 years or over
2. Cryptogenic ischaemic stroke in first 72 hours in patients not known to have atrial fibrillation (AF) or >50% carotid stenosis ipsilateral to an anterior circulation stroke
OR
3.. Cryptogenic TIA’s in first 72 hours in patients not known to have AF or >50% carotid stenosis, where the ABCD2 >4 and
3.1. ABCD2 score >4
3.2. Hemianopia
3.3. Hysphasia
3.4. DWI-positive MRI in a non-lacunar distribution

Exclusion criteria:
1. Patients unable to provide informed consent
2. Patients who are not candidates for anticoagulation
3. Patients already on anticoagulation for other causes
4. Patients with significant carotid stenosis (>50% carotid stenosis)
5. Patients with known atrial fibrillation
6. Patients with a non-AF cardiac condition requiring anticoagulation
7. A currently implanted cardiac device (e.g. Pacemarker, Implanted Cardiac Defibrillator)


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Ischaemic stroke
Circulatory System
Ischaemic stroke

Intervention(s)

Volunteers are randomised to standard cardiac work-up (24-hour Holter monitoring, CMP-arm) or a novel patch-based monitoring system (ZP-arm).

CMP-arm: Patients will receive current medical practice of ambulatory outpatient 24-hour Holter-monitoring only.

ZP-arm: In the baseline session, patients will have a patch applied to their anterior chest wall with the device kept in-situ for 14-days continuously (removed only for short-intervals, e.g. MRI-scans). On day 14, volunteers will receive a phone call reminder to return the device by post. Patients will also have the standard practice of a 24-hour Holter monitor.

All patients in both arms will also receive standard brain and vascular imaging, a routine 12-lead ECG and a transthoracic ECHO. Patients in both study arms will then be followed up for 90 days.

Primary Outcome(s)

Total AF detection rate is determined using either a standard Holter electrocardiogram or a Ziopatch cardiac monitor at day 28.

Secondary Outcome(s)

1. AF-detection-rate is determined using Holter-monitor versus ZioPatch cardiac monitor within the same patients (intragroup) using at day 90
2. AF detection rate is determined using Holter-monitor versus ZioPatch cardiac monitor at day 28
3. Anticoagulation rate is determined using review of patient clinical record at day 90
4. Ischaemic stroke or TIA rates is determined using review of patient clinical record at day 90
5. Mortality at is determined using review of patient clinical record at day 90
6. Time-to-reporting of cardiac monitoring is determined using review of patient clinical record at day 90
7. Patient feedback on cardiac monitoring is determined using questionnaires at day 90

Secondary ID(s)

20133

Source(s) of Monetary Support

Bristol-Myers Squibb

Ethics review

Status:
Approval date:
Contact:

London - Surrey Borders Research Ethics Committee, ref: 15/LO/1534

Results

• Results available: Yes
• Date Completed: 14/02/2017