Early prolonged ambulatory heart monitoring in patients with stroke

Early Prolonged Ambulatory Cardiac monitoring in Stroke: A prospective randomised open blinded endpoint study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN50253271

Enrollment

120

Registered

2016-01-28

Start date

2016-02-03

Completion date

Unknown

Last updated

2019-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischaemic stroke Circulatory System Ischaemic stroke

Interventions

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 me

Eligibility

Sex/Gender

All

Inclusion 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

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026