Ischemic StrokeNCT02578979
Serial ECG Versus Holter to Detect Atrial Fibrillation in Elderly Ischemic Stroke Patients
A study testing Electrocardiogram and Holter in people with Ischemic Stroke, run by Chang Gung Memorial Hospital at 6 sites in Taiwan.
Trial summary
Paroxysmal atrial fibrillation is often undetected because characteristics such as short duration, episodic, and frequently asymptomatic nature make it challenging to diagnose at the bedside, leading to suboptimal secondary prevention. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Electrocardiogram and Holter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 826 participants
- Where
- 6 sitesTaiwan
- Study dates
- 1 Oct 2015to 31 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Cerebral ischemia defined as stroke (sudden focal neurologic deficit lasting >24 h consistent with the territory of a major cerebral artery and categorized as ischemic) and/or a corresponding lesion on brain imaging
- Stroke symptoms within 2 days
- Age ≥65 years
Who cannot join
- History of atrial fibrillation or documented atrial fibrillation prior to randomization
- Indication for oral anticoagulation at randomization
- Absolute contraindication for oral anticoagulation at randomization
- Intracerebral hemorrhage in medical history
- Implanted pacemaker device or cardioverter/defibrillator
- End stage renal disease
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Taiwan6 sites
Chia-yi Christian Hospital
Chiayi City, 600
Dalin Tzu Chi General Hospital
Dalin, 622
Chang Gung Memorial Hospital, Keelung Branch
Keelung, 204
Chang Gung Memorial Hospital, Chiayi Branch
Puzih, 613
National Taiwan University Hospital
Taipei, 100
Chang Gung Memorial Hospital, Linkuo Branch
Taoyuan, 333
About this study
Official title: Serial Electrocardiogram Versus Holter to Detect Atrial Fibrillation in Elderly Patients With Acute Ischemic Stroke: Study Protocol of a Randomized Controlled Trial
Paroxysmal atrial fibrillation is often undetected because characteristics such as short duration, episodic, and frequently asymptomatic nature make it challenging to diagnose at the bedside, leading to suboptimal secondary prevention. It is not uncommon for paroxysmal atrial fibrillation to be undetected in a single electrocardiogram (ECG) on admission. Conventional 24-hour Holter monitoring is often used to detect paroxysmal atrial fibrillation. However, systematic review suggests Holter monitoring will identify atrial fibrillation in only an additional 4.6% of patients, no better than detection rates observed in groups lacking routine monitoring. On the other hand, for ischemic stroke patients with sinus rhythm at baseline but paroxysmal atrial fibrillation still suspected, no recommendation beyond repeated 12-lead ECGs is made in the United Kingdom guideline. Serial 12-lead ECG has been used to detect possible paroxysmal atrial fibrillation among acute ischemic stroke patients and found 15 new cases of atrial fibrillation in 133 acute ischemic stroke patients (11.3%) without atrial fibrillation at baseline. The optimal investigation strategy, including modality, duration of investigation, and patient subgroup remains undefined, not only for efficacy in the detection of atrial fibrillation, but also cost-effectiveness in healthcare systems. The objective of this project is to conduct a pragmatic multicenter randomized controlled trial for the comparison of serial 12-lead ECG once daily for 5 days and 24-hour Holter to detect paroxysmal atrial fibrillation in acute ischemic stroke patients without atrial fibrillation identified by baseline ECG or history.
Read the detailed description
Investigators plan to enroll 900 participants from six hospitals in Taiwan. Patients will be eligible for enrollment if they are admitted due to acute ischemic stroke within 2 days, with 65 years of age or older, do not have known atrial fibrillation on history or baseline ECG at admission. Investigators will randomly assigned participants in a 1:1 ratio to undergo daily 12-lead ECG once daily for 5 days (intervention group) or 24-hour Holter monitoring (control group).
- Conditions
- Ischemic Stroke
- Being tested
- Electrocardiogram, Holter
- Keywords
- atrial fibrillation, ischemic stroke, electrocardiogram, holter
- Medical subject headings
- Ischemic Stroke, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectrocardiogramDevice
Patients will receive electrocardiogram for detecting atrial fibrillation - a 5-day routine ECG.
HolterDevice
Patients will receive electrocardiogram for detecting atrial fibrillation - a 24-h Holter.
| Study group | Role | What they receive |
|---|---|---|
| ECG for 5 days | Experimental | Patients will receive 12-lead electrocardiogram for 5 days during their hospitalization. Receives: Device: Electrocardiogram |
| 24-h Holter | Active comparator | Patients will receive a 24-h Holter during their hospitalization. Receives: Device: Holter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of atrial fibrillation detected
Measured: within 3 month of stroke onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study start1 Oct 2015
- Primary completion31 Jul 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 826 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital, Chiayi Christian Hospital, Dalin Tzu Chi General Hospital
- Responsible party
- Principal investigator, Meng Lee, Chang Gung Memorial Hospital
- Investigators
- Meng Lee, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02578979
- Sponsor's protocol ID
- NMRPD1E0891
- Status last verified
- Jul 2019
- First submitted
- 12 Oct 2015
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Huang WY, Lee M, Sung SF, Tang SC, Chang KH, Huang YS, Lee JD, Lee TH, Jeng JS, Chung CM, Wu YL, Hsieh TT, Ovbiagele B. Atrial fibrillation trial to evaluate real-world procedures for their utility in helping to lower stroke events: A randomized clinical trial. Int J Stroke. 2021 Apr;16(3):300-310. doi: 10.1177/1747493020938297. Epub 2020 Jul 8.
PubMed 32640882Hsieh TT, Lee M, Huang WY, Tang SC, Sung SF, Chang KH, Lee JD, Lee TH, Huang YS, Jeng JS, Chung CM, Wu YL, Ovbiagele B. Atrial fibrillation trial to evaluate real-world procedures for their utility in helping to lower stroke events (AFTER-PULSE): Study protocol for a randomized controlled trial. Contemp Clin Trials Commun. 2017 Jun;6:127-130. doi: 10.1016/j.conctc.2017.04.005. Epub 2017 Apr 26.
PubMed 29082335
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serial Electrocardiogram Versus Holter to Detect Atrial Fibrillation in Elderly Patients With Acute Ischemic Stroke: Study Protocol of a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02578979
- Acronym / sponsor ID
- NMRPD1E0891
- Conditions
- Ischemic Stroke
- Keywords
- atrial fibrillation, ischemic stroke, electrocardiogram, holter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 826 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital, Chiayi Christian Hospital, Dalin Tzu Chi General Hospital
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 19 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Paroxysmal atrial fibrillation is often undetected because characteristics such as short duration, episodic, and frequently asymptomatic nature make it challenging to diagnose at the bedside, leading to suboptimal secondary prevention. It is not uncommon for paroxysmal atrial fibrillation to be undetected in a single electrocardiogram (ECG) on admission. Conventional 24-hour Holter monitoring is often used to detect paroxysmal atrial fibrillation. However, systematic review suggests Holter monitoring will identify atrial fibrillation in only an additional 4.6% of patients, no better than detection rates observed in groups lacking routine monitoring. On the other hand, for ischemic stroke patients with sinus rhythm at baseline but paroxysmal atrial fibrillation still suspected, no recommendation beyond repeated 12-lead ECGs is made in the United Kingdom guideline. Serial 12-lead ECG has been used to detect possible paroxysmal atrial fibrillation among acute ischemic stroke patients and found 15 new cases of atrial fibrillation in 133 acute ischemic stroke patients (11.3%) without atrial fibrillation at baseline. The optimal investigation strategy, including modality, duration of investigation, and patient subgroup remains undefined, not only for efficacy in the detection of atrial fibrillation, but also cost-effectiveness in healthcare systems. The objective of this project is to conduct a pragmatic multicenter randomized controlled trial for the comparison of serial 12-lead ECG once daily for 5 days and 24-hour Holter to detect paroxysmal atrial fibrillation in acute ischemic stroke patients without atrial fibrillation identified by baseline ECG or history.
Detailed description
Investigators plan to enroll 900 participants from six hospitals in Taiwan. Patients will be eligible for enrollment if they are admitted due to acute ischemic stroke within 2 days, with 65 years of age or older, do not have known atrial fibrillation on history or baseline ECG at admission. Investigators will randomly assigned participants in a 1:1 ratio to undergo daily 12-lead ECG once daily for 5 days (intervention group) or 24-hour Holter monitoring (control group).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECG for 5 days | Experimental | Device: ElectrocardiogramPatients will receive 12-lead electrocardiogram for 5 days during their hospitalization. |
| 24-h Holter | Active comparator | Device: HolterPatients will receive a 24-h Holter during their hospitalization. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Cerebral ischemia defined as stroke (sudden focal neurologic deficit lasting >24 h consistent with the territory of a major cerebral artery and categorized as ischemic) and/or a corresponding lesion on brain imaging
- Stroke symptoms within 2 days
- Age ≥65 years
Key exclusion criteria (6 listed)
- History of atrial fibrillation or documented atrial fibrillation prior to randomization
- Indication for oral anticoagulation at randomization
- Absolute contraindication for oral anticoagulation at randomization
- Intracerebral hemorrhage in medical history
- Implanted pacemaker device or cardioverter/defibrillator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectrocardiogramPatients will receive electrocardiogram for detecting atrial fibrillation - a 5-day routine ECG. | Device | ECG for 5 days |
| HolterPatients will receive electrocardiogram for detecting atrial fibrillation - a 24-h Holter. | Device | 24-h Holter |
Primary outcome
Number of atrial fibrillation detected
Time frame: within 3 month of stroke onset
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
- Derived from this study: PubMed 32640882Huang WY, Lee M, Sung SF, Tang SC, Chang KH, Huang YS, Lee JD, Lee TH, Jeng JS, Chung CM, Wu YL, Hsieh TT, Ovbiagele B. Atrial fibrillation trial to evaluate real-world procedures for their utility in helping to lower stroke events: A randomized clinical trial. Int J Stroke. 2021 Apr;16(3):300-310. doi: 10.1177/1747493020938297. Epub 2020 Jul 8.
- Derived from this study: PubMed 29082335Hsieh TT, Lee M, Huang WY, Tang SC, Sung SF, Chang KH, Lee JD, Lee TH, Huang YS, Jeng JS, Chung CM, Wu YL, Ovbiagele B. Atrial fibrillation trial to evaluate real-world procedures for their utility in helping to lower stroke events (AFTER-PULSE): Study protocol for a randomized controlled trial. Contemp Clin Trials Commun. 2017 Jun;6:127-130. doi: 10.1016/j.conctc.2017.04.005. Epub 2017 Apr 26.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meng Lee, MD principal investigator
Chang Gung Memorial Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrocardiogram and Holter in people with Ischemic Stroke, run by Chang Gung Memorial Hospital at 6 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of atrial fibrillation detected (time frame: within 3 month of stroke onset). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02578979, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2019.